ABCDEFGHIJMNOPQRSTUVWXYZAAABACADAEAFAGAHAI
1
YearBrandBLA/ NDADrugs@FDA LinkDrug Trial Snapshot LinkEnrollment (per Snapshot)Number of Clinical Trials (per Snapshot)Clinical Trial NCT # (per Snapshot)INNFDA Approval dateDate of EMA approval (D/M/Y form)FDA Review ClassORIGNDA Chem TypeWHO ATC CodeOrphan for initial approved indicationNumber of Orphan indications approved on date of initial FDA approvalDesignation Date for initial orphan indicationFDA numberBreakthrough* (Designation began 2013)FastrackPRVIndicationShort indicationCancerOriginal applicantCompanyOriginal label URL
2
2020GemtesaNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=213006https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-gemtesa1,0851vibegron2020-Dec-23STANDARDORIG-11213006To treat overactive bladderoveractive bladderUROVANT SCIENCES GMBH
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213006s000lbl.pdf
3
2020EbangaBLAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761172https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-ebanga3421ansuvimab-zykl2020-Dec-21ORIG-1ORPHAN15/8/2019761172To treat ebolaebolaRIDGEBACK BIOTHERAPEUTICSnot listed
4
2020OrgovyxNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=214621https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-orgovyx9301NCT03085095relugolix2020-Dec-18PRIORITYORIG-11214621
To treat advanced prostate cancer, Press Release
prostate cancercancerMYOVANT SCIENCES
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214621s000lbl.pdf
5
2020MargenzaBLAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761150https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-margenza5361NCT02492711margetuximab (anti-HER2 mAb2020-Dec-16ORIG-1761150To treat HER2+ breast cancerbreast cancercancerMACROGENICS INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761150s000lbl.pdf
6
2020KlisyriNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=213189https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-klisyri2tirbanibulin2020-Dec-14STANDARDORIG-11213189
To treat actinic Keratosis of the face or scalp
actinic KeratosisALMIRALL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213189s000lbl.pdf
7
2020OrladeyoNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=214094https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-orladeyo1201NCT03485911berotralstat2020-Dec-04STANDARDORIG-11ORPHAN111/01/2017214094
To treat patients with hereditary angioedema
hereditary angioedema
BioCryst Pharmaceuticals, Inc.BIOCRYST
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214094s000lbl.pdf
8
2020
Gallium 68 PSMA-11
NDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212642https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-ga-68-psma-119602Trial 1: NCT0336847/NCT02919111; Trial 2: NCT02940262/NCT02918357Gallium 68 PSMA-112020-Dec-01STANDARDORIG-11212642, 212643
For detection and localization of prostate cancer
prostate cancercancerUCLA Nuclear Medicine, UCSF Nuclear MedicineUNIV CA LOS ANGELES
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212642s000lbl.pdf
9
2020DanyelzaBLAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761171https://www.fda.gov/drugs/drug-approvals-and-databases/drugs-trials-snapshot-danyelza972NCT03363373; NCT01757626naxitamab-gqgk2020-Nov-25ORIG-1ORPHAN106/24/2013761171
To treat high-risk refractory or relapsed neuroblastoma
neuroblastomacancerY-mAbs Therapeutics, Inc.Y-MABS THERAPEUTICS INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761171lbl.pdf
10
2020ImcivreeNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=213793https://www.fda.gov/drugs/drug-trials-snapshots-imcivree272NCT02896192; NCT03287960setmelanotide2020-Nov-25PRIORITYORIG-11ORPHAN204/04/2016213793
To treat obesity and the control of hunger associated with pro-opiomelanocortin deficiency, a rare disorder that causes severe obesity that begins at an early age
obesity disorderRHYTHM Pharmaceuticals, Inc.RHYTHM
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213793Orig1s000RPLlbl.pdf
11
2020OxlumoNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=214103https://www.fda.gov/drugs/drug-approvals-and-databases/drugs-trials-snapshot-oxlumo552NCT03681184; NCT03905694lumasiran2020-Nov-23PRIORITYORIG-11ORPHAN102/08/2016214103To treat hyperoxaluria type 1hyperoxaluriaAlnylam PharmaceuticalsALNYLAM PHARMS INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214103lbl.pdf
12
2020ZokinvyNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=213969https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-zokinvy622NCT00425607; NCT00916747lonafarnib2020-Nov-20PRIORITYORIG-11ORPHAN104/18/2011213969
To treat rare conditions related to premature aging
premature agingEiger BioPharmaceuticals, Inc.EIGER BIOPHARMS
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213969s000lbl.pdf
13
2020VekluryNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=214787https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-veklury2,0433NCT04280705; NCT04292899; NCT04292730remdesivir2020-Oct-22PRIORITYORIG-11214787To treat COVID-19COVID-19GILEAD SCIENCES INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214787Orig1s000lbl.pdf
14
2020InmazebBLAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761169https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-inmazeb3221NCT03719586
atoltivimab, maftivimab, and odesivimab-ebgn
2020-Oct-14ORIG-1ORPHAN107/14/2016761169To treat ebola virusebolaREGENERON PHARMACEUTICALS
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761169s000lbl.pdf
15
2020GavretoNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=213721https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-gavreto2201NCT03037385pralsetinib2020-Sep-04PRIORITYORIG-11ORPHAN104/11/2018213721To treat non-small lung cancerlung cancercancerBLUEPRINT MEDICINES
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213721s000lbl.pdf
16
2020DetectnetNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=213227https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-detectnet1752Not listedcopper Cu 64 dotatate injection2020-Sep-03PRIORITYORIG-11ORPHAN105/18/2016213227
To help detect certain types of neuroendocrine tumors
neuroendocrine tumors
cancerRADIOMEDIX
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213227s000lbl.pdf
17
2020SogroyaBLAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761156https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-sogroya3001NCT02229851somapacitan-beco2020-Aug-28ORIG-1761156Growth hormoneGrowth hormoneNOVO NORDISK INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761156s000lbl.pdf
18
2020WinleviNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=213433https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-winlevi1,4402NCT02608450; NCT02608476clascoterone2020-Aug-26STANDARDORIG-11213433To treat acneacneCASSIOPEA SPA
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213433s000lbl.pdf
19
2020EnspryngBLAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761149https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-enspryng1162NCT02073279; NCT02028884satralizumab-mwge2020-Aug-14ORIG-1ORPHAN1761149
To treat neuromyelitis optica spectrum disorder
optical disorderGENENTECH
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761149s000lbl.pdf
20
2020ViltepsoNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212154https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-viltepso162Trial 1: NCT02740972; Trial 2 (NCT not listed)viltolarsen2020-Aug-12PRIORITYORIG-11ORPHAN101/12/2017212154
To treat Duchenne muscular dystrophy
Duchenne muscular dystrophy
NIPPON SHINYAKU
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212154Orig1s000lbl.pdf
21
2020OlinvykNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=210730https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-olinvyk1,5583Trial 1: NCT02815709; Trial 2: NCT02820324; Trial 3 (NCT not listed)oliceridine2020-Aug-07STANDARDORIG-11210730
To manage acute pain in certain adults
pain managementTREVENA
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210730s000lbl.pdf
22
2020EvrysdiNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=213535https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-evrysdi2012NCT02913482; NCT02908685risdiplam2020-Aug-07PRIORITYORIG-11ORPHAN101/04/2017213535To treat spinal muscular atrophySMAGENENTECH INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213535s000lbl.pdf
23
2020LampitNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=213464https://www.fda.gov/drugs/development-approval-process-drugs/drug-trials-snapshots-lampit2191NCT02625974nifurtimox2020-Aug-06PRIORITYORIG-11ORPHAN108/05/2010213464
To treat Chagas disease in certain pediatric patients younger than age 18
ChagasBAYER HEALTHCARE
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213464s000lbl.pdf
24
2020BlenrepBLAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761158https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-blenrep971NCT03525678belantamab mafodotin-blmf2020-Aug-05ORIG-1ORPHAN106/22/2017761158To treat multiple myelomamultiple myelomacancerGLAXOSMITHKLINE
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761158s000lbl.pdf
25
2020MonjuviBLAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761163https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshots-monjuvi811NCT02399085tafasitamab-cxix2020-Jul-31ORIG-1ORPHAN112/01/2014761163
To treat relapsed or refractory diffuse large B-cell lymphoma
B-cell lymphomacancerMORPHOSYS US INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761163s000lbl.pdf
26
2020XeglyzeNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206966https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-xeglyze6992Not listedabametapir2020-Jul-24STANDARDORIG-11206966To treat head liceliceDR REDDYS LABS SA
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206966lbl.pdf
27
2020InqoviNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212576https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-inqovi2132NCT02103478; NCT03306264decitabine and cedazuridine2020-Jul-07PRIORITYORIG-11ORPHAN108/21/2019212576
To treat adult patients with myelodysplastic syndromes
myelodysplastic syndromes
OTSUKA
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212576s000lbl.pdf
28
2020RukobiaNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212950https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-rukobia2721NCT02362503fostemsavir2020-Jul-02PRIORITYORIG-11212950To treat HIVHIVVIIV HLTHCARE
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212950s000lbl.pdf
29
2020ByfavoNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212295https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-byfavo1,0063NCT02290873; NCT02296892; NCT02532647remimazolam2020-Jul-02STANDARDORIG-11, 4212295For sedationsedationACACIA
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212295s000lbl.pdf
30
2020DojolviNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=213687https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-dojolvi2653NCT018863; NCT022141; NCT01379625triheptanoin2020-Jun-30STANDARDORIG-11ORPHAN104/15/2015213687
To treat molecularly long-chain fatty acid oxidation disorders
fatty acid oxidation disorders
ULTRAGENYX PHARM INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213687s000lbl.pdf
31
2020ZepzelcaNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=213702https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-zepzelca1051NCT02454972lurbinectedin2020-Jun-15PRIORITYORIG-11ORPHAN108/01/2018213702
To treat metastatic small cell lung cancer
lung cancercancerJAZZ
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213702s000lbl.pdf
32
2020UpliznaBLAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761142https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-uplizna2131NCT02200770inebilizumab-cdon2020-Jun-11ORIG-1ORPHAN102/10/2016761142
To treat neuromyelitis optica spectrum disorder
optical disorderVIELA BIO
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761142s000lbl.pdf
33
2020TauvidNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212123https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-tauvid1,92119Not listedflortaucipir F182020-May-28PRIORITYORIG-11212123
Diagnostic agent for patients with Alzheimer’s disease
Alzheimer’sAVID RADIOPHARMS INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212123s000lbl.pdf
34
2020ArtesunateNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=213036https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-artesunate6,8863Trial 3 enrollment missingNot listedartesunate2020-May-26PRIORITYORIG-11ORPHAN103/28/2006213036, 213170To treat severe malariamalariaAMIVAS
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213036s000lbl.pdf
35
2020CeriannaNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212155https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-cerianna1092Plus Published data of 1207 patients from multiple trials Not listedfluoroestrdiol F182020-May-20STANDARDORIG-11212155
Diagnostic imaging agent for certain patients with breast cancer
imaging agent for breast cancer
ZIONEXA
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212155s000lbl.pdf
36
2020QinlockNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=213973https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-qinlock1291NCT03353753ripretinib2020-May-15PRIORITYORIG-11ORPHAN110/02/2014213973
To treat advanced gastrointestinal-stromal tumors
GI cancercancerDECIPHERA PHARMS
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213973s000lbl.pdf
37
2020RetevmoNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=213246https://www.fda.gov/drugs/development-approval-process-drugs/drug-trials-snapshots-retevmo7021NCT03157128selpercatinib2020-May-08PRIORITYORIG-11ORPHAN210/30/2019213246To treat lung and thyroid cancers
lung and thyroid cancers
cancerLOXO ONCOLOGY INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213246s000lbl.pdf
38
2020TabrectaNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=213591https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-tabrecta3341NCT02414139capmatinib2020-May-06PRIORITYORIG-11ORPHAN103/15/2019213591
To treat patients with non small cell lung cancer
lung cancercancerNOVARTIS PHARM
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213591s000lbl.pdf
39
2020OngentysNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212489https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-ongentys5222NCT01568073; NCT01227655opicapone2020-Apr-24STANDARDORIG-11212489
To treat patients with Parkinson’s disease experiencing “off” episodes
Parkinson'sNEUROCRINE
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212489s000lbl.pdf
40
2020TrodelvyBLAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761115https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-trodelvy1081NCT01631552sacituzumab govitecan-hziy2020-Apr-22ORIG-1761115
To treat adult patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease
breast cancercancerIMMUNOMEDICS INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761115s000lbl.pdf
41
2020PemazyreNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=213736https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-pemazyre1461NCT02924376pemigatinib2020-Apr-17PRIORITYORIG-11ORPHAN103/12/2018213736
To treat certain patients with cholangiocarcinoma, a rare form of cancer that forms in bile ducts
bile duct cancercancerINCYTE CORP
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213736s000lbl.pdf
42
2020TukysaNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=213411https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-tukysa6011NCT02614794tucatinib2020-Apr-17PRIORITYORIG-11ORPHAN106/05/2017213411
To treat advanced unresectable or metastatic HER2-positive breast cancer
breast cancercancerSEAGEN
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213411s000lbl.pdf
43
2020KoselugoNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=213756https://www.fda.gov/drugs/resources-information-approved-drugs/drug-trials-snapshots-koselugo501NCT01362803selumetinib2020-Apr-10PRIORITYORIG-11ORPHAN102/14/2018213756
To treat neurofibromatosis type 1, a genetic disorder of the nervous system causing tumors to grow on nerves
nervous system disorder
ASTRAZENECA PHARMS
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213756s000lbl.pdf
44
2020ZeposiaNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=209899https://www.fda.gov/drugs/development-approval-process-drugs/drug-trials-snapshots-zeposia1,7672NCT02294058; NCT02047734ozanimod2020-Mar-25STANDARDORIG-11209899
To treat relapsing forms of multiple sclerosis
MSCELGENE INTL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209899s000lbl.pdf
45
2020IsturisaNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212801https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-isturisa1371NCT02180217osilodrostat2020-Mar-06STANDARDORIG-11ORPHAN109/13/2013212801
To treat adults with Cushing’s disease who either cannot undergo pituitary gland surgery or have undergone the surgery but still have the disease
Cushing's diseaseRECORDATI RARE
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212801s000lbl.pdf
46
2020SarclisaBLAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761113https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-sarclisa3071NCT02990338isatuximab2020-Mar-02ORIG-11ORPHAN105/22/2014761113To treat multiple mylomamultiple myelomacancerSANOFI AVENTIS US
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761113s000lbl.pdf
47
2020Nurtec ODTNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212728https://www.fda.gov/drugs/development-approval-process-drugs/drug-trials-snapshots-nurtec-odt1,3511NCT03461757rimegepant2020-Feb-27PRIORITYORIG-11212728To treat migrainemigrainesBIOHAVEN PHARM
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212728s000lbl.pdf
48
2020BarhemsysNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=209510https://www.fda.gov/drugs/development-approval-process-drugs/drug-trials-snapshots-barhemsys2,3234Not listedamisulpride2020-Feb-26STANDARDORIG-11209510
To help prevent nausea and vomiting after surgery
nauseaACACIA
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209510s000lbl.pdf
49
2020VyeptiNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761119https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-vyepti1,7412NCT02559895; NCT02974153eptinezumab-jjmr2020-Feb-21ORIG-11761119
For the preventive treatment of migraine in adults
migraines
Lundbeck Seattle BioPharmaceuticals, Inc.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761119s000lbl.pdf
50
2020NexletolNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=211616https://www.fda.gov/drugs/resources-information-approved-drugs/drug-trials-snapshots-nexletol3,0092NCT02666664; NCT02991118bempedoic acid2020-Feb-21STANDARDORIG-11211616
To treat adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C
cholesterol-related heart disease
ESPERION THERAPS INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211616s000lbl.pdf
51
2020PizensyNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=211281https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-pizensy5941NCT02819297lactitol2020-Feb-12STANDARDORIG-11211281
To treat chronic idiopathic constipation (CIC) in adults
chronic constipationBRAINTREE LABS
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211281s000lbl.pdf
52
2020TazverikNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=211723https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-tazverik621NCT02601950tazemetostat2020-Jan-23PRIORITYORIG-11ORPHAN106/15/2017211723, 213400To treat epithelioid sarcomaepithelioid sarcomacancerEPIZYME INC
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211723s000lbl.pdf
53
2020TepezzaBLAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761143https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-tepezza1702NCT01868997; NCT03298867teprotumumab-trbw2020-Jan-21ORIG-11ORPHAN105/06/2013761143To treat Thyroid eye diseasethyroid eye diseaseHORIZON THERAPEUTICS IRELAND
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761143s000lbl.pdf
54
2020AyvakitNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212608https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-ayvakit2041NCT02508532avapritinib2020-Jan-09PRIORITYORIG-11ORPHAN101/06/2016212608
To treat adults with unresectable or metastatic gastrointestinal stromal tumor (GIST)
GI cancercancerBLUEPRINT MEDICINES
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212608s000lbl.pdf
55
56
2019UbrelvyNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=211765https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-ubrelvy24232NCT02828020, NCT02867709ubrogepantDec 23, 2019STANDARD211765to treat acute treatment of migraine with or without aura in adultsmigraine
57
2019EnhertuBLAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761139https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-enhertu2342NCT03248492, NCT02564900fam-trastuzumab deruxtecan-nxkiDec 20, 2019PRIORITYn/a761139To treat metastatic breast cancercancercancer
58
2019DayvigoNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212028https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-dayvigo16922NCT02952820, NCT02783729lemborexantDec 20, 2019STANDARD212028To treat insomniainsomnia
59
2019CaplytaNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=209500https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-caplyta8183
NCT01499563, NCT02282761, NCT02469155
lumateperone tosylateDec 20, 2019STANDARD209500To treat schizophreniamental health
60
2019TissueBlueNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=209569https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-tissueblue---Brilliant Blue G Ophthalmic SolutionDec 20, 2019PRIORITYorphan209569Dye used in eye surgeryeye surgeryDUTCH OPHTHALMIC
61
2019PadcevBLAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761137https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-padcev1251NCT03219333enfortumab vedotin-ejfvDec 18, 2019PRIORITYn/a761137To treat refractory bladder cancercancercancerAstellas
62
2019Vyondys 53NDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=211970https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-vyondys-53622NCT02310906, NCT0250381golodirsenDec 12, 2019PRIORITYorphan211970To treat certain patients with Duchenne muscular dystrophy
Duchenne muscular dystrophy
SAREPTA THERAPS INC
63
2019OxbrytaNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=213137https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-oxbryta1821NCT03036813voxelotorNov 25, 2019PRIORITYorphan213137To treat sickle cell diseasesickle cell diseaseGLOBAL BLOOD THERAPS
64
2019XcopriNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212839https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-xcopri6552NCT01866111, NCT01397968cenobamateNov 21, 2019STANDARD212839To treat partial onset seizuresseizures
65
2019GivlaariNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212194https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-givlaari941NCT03338816givosiranNov 20, 2019PRIORITYorphan212194To treat acute hepatic porphyria, a rare blood disorder
acute hepatic porphyria
ALNYLAM PHARMS INC
66
2019AdakveoBLAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761128https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-adakveo1321NCT01895361crizanlizumab-tmcaNov 15, 2019PRIORITYorphan761128To treat patients with painful complication of sickle cell diseasesickle cell diseaseNOVARTIS PHARMS CORP
67
2019FetrojaNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=209445https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-fetroja4481NCT02321800cefiderocolNov 14, 2019PRIORITY209445To treat patients with complicated urinary tract infections who have limited or no alternative treatment optionsurinary tract infections
68
2019BrukinsaNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=213217https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-brukinsa1182NCT03206970, NCT 02343120zanubrutinibNov 14, 2019PRIORITYorphan213217To treat certain patients with mantle cell lymphoma, a form of blood cancercancercancerBEIGENE
69
2019ReblozylBLAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761136https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-reblozyl3361NCT02604433luspatercept–aamtNov 8, 2019PRIORITYorphan761136For the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusionsanemiaCELGENE CORP
70
2019ExEm FoamNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212279https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-exem-foam1822
"Trial A from the article by Riganelli et al. 2018* and Trial B by from the article by Ludwin et al. 2017**"
air polymer-type ANov 7, 2019STANDARD212279A diagnostic agent used to assess fallopian tube patency (openness) in women with known or suspected infertility
diagnosis for fallopian tube patency
71
2019TrikaftaNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212273https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-trikafta5102NCT03525444, NCT03525548elexacaftor/ivacaftor/tezacaftorOct 21, 2019PRIORITYorphan212273To treat patients 12 years of age and older with the most common gene mutation that causes cystic fibrosiscystic fibrosisVERTEX PHARMS INC
72
2019ReyvowNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=211280https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-reyvow44392NCT02439320, NCT02605174lasmiditanOct 11, 2019STANDARD211280For the acute treatment of migraine with or without aura, in adultsmigraineEli Lilly
73
2019
FLUORODOPA F18
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=200655https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-fluorodopa-f-18561-fluorodopa F 18Oct 10, 2019STANDARD200655A diagnostic agent for use in positron emission tomography (PET) to help diagnose adult patients with suspected Parkinsonian syndromes (PS)Parkinson's
74
2019ScenesseNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=210797https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-scenesse2443
NCT 01605136, NCT00979745, NCT01097044
afamelanotideOct 8, 2019PRIORITYorphan210797To increase pain-free light exposure in adult patients with a history of phototoxic reactions (damage to skin) from erythropoietic protoporphyriaSkin diseaseCLIVUNEL INC
75
2019BeovuBLAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761125https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-beovu14592NCT02307682, NCT02434328brolucizumab–dbllOct 7, 2019PRIORITY761125Treatment of wet age-related macular degenerationvisionNOVARTIS PHARMS CORP
76
2019AkliefNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=211527https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-aklief24202NCT02566369, NCT02556788trifaroteneOct 4, 2019STANDARD211527For the topical treatment of acne vulgaris in patients 9 years of age and olderSkin diseaseGALDERMA R AND D
77
2019IbsrelaNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=211801https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-ibsrela11992NCT02686138, NCT02621892tenapanorSep 12, 2019STANDARD211801To treat irritable bowel syndrome with constipation in adults.
irritable bowel syndrome
ARDELYX INC
78
2019NourianzNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=22075https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-nourianz11604
NCT00456586, NCT00199407, NCT00455507, NCT00955526
istradefyllineAug 27, 2019STANDARD22075To treat adult patients with Parkinson’s disease experiencing “off” episodesParkinson'sKYOWA KIRIN
79
2019
GALLIUM DOTATOC GA 68
NDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=210828https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-ga-68-dotatoc3343NCT1619865, NCT1869725, NCT2441062Ga-68-DOTATOCAug 21, 2019PRIORITYorphan210828For use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs)DiagnosticUIHC PET IMAGING
80
2019XenletaNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=211672https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-xenleta12892NCT02559310, NCT02813694lefamulinAug 19, 2019PRIORITY211672, 211673To treat adults with community-acquired bacterial pneumoniapneumonia
81
2019RinvoqNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=211675https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-rinvoq31415
NCT02706873, NCT02706951, NCT02675426, NCT02629159, NCT02706847
upadacitinibAug 16, 2019PRIORITY211675To treat adults with moderately to severely active rheumatoid arthritisRAABBVIE INC
82
2019InrebicNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212327https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-inrebic1921NCT01437787fedratinibAug 16, 2019PRIORITYorphan212327To treat adult patients with intermediate-2 or high-risk primary or secondary myelofibrosiscancercancerIMPACT
83
2019RozlytrekNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212725
https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-rozlytrek
3554
EudraCT 2012-000148-88, NCT02097810, NCT02568267, NCT02650401
entrectinibAug 15, 2019PRIORITYorphan212725, 212726To treat adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive; To treat adult and pediatric patients 12 years of age and older with solid tumorscancercancerGENENTECH INC
84
2019WakixNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=211150https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-wakix2663
NCT01067222, NCT01638403, NCT01800045
pitolisantAug 14, 2019PRIORITYorphan211150To treat excessive daytime sleepiness (EDS) in adult patients with narcolepsyexcessive sleepinessHARMONY
85
2019PRETOMANIDNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212862https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-pretomanid1091NCT02333799pretomanidAug 14, 2019PRIORITYorphan212862For treatment-resistant forms of tuberculosis that affects the lungsTBMYLAN IRELAND LTD
86
2019TuralioNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=211810https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-turalio1201NCT02371369pexidartinibAug 2, 2019PRIORITYorphan211810To treat adult patients with symptomatic tenosynovial giant cell tumorcancercancerDAIICHI SANKYO INC
87
2019NubeqaNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212099https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-nubeqa15091NCT02200614darolutamideJul 30, 2019PRIORITY212099To treat adult patients with non-metastatic castration resistant prostate cancercancercancerBAYER HEALTHCARE
88
2019AccruferNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212320https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-accrufer2953
NCT01252221, NCT01340872, NCT02968368
ferric maltolJul 25, 2019STANDARD212320To treat iron deficiency anemia in adultsanemiaSHIELD TX
89
2019RecarbrioNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212819https://www.fda.gov/drugs/resources-information-approved-drugs/drug-trial-snapshot-recarbrio4302NCT01505634, NCT01506271
imipenem, cilastatin and relebactam
Jul 16, 2019PRIORITY212819To treat complicated urinary tract and complicated intra-abdominal infections
urinary tract and intra-abdominal infections
MSD MERCK CO
90
2019XpovioNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212306https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-xpovio2021NCT02336815selinexorJul 3, 2019PRIORITYorphan212306To treat adult patients with relapsed or refractory multiple myeloma (RRMM)cancercancerKARYOPHARM THERAPS
91
2019VyleesiNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=210557https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-vyleesi12672NCT02333071, NCT02338960bremelanotideJun 21, 2018STANDARD210557To treat hypoactive sexual desire disorder in premenopausal women.sexual healthAMAG PHARMS INC
92
2019PolivyBLAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761121https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-polivy801NCT02257567polatuzumab vedotin-piiqJun 10, 2019PRIORITYorphan761121To treat adult patients with relapsed or refractory diffuse large B-cell lymphomacancercancerGENENTECH INC
93
2019PiqrayNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212526https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-piqray5711NCT02437318alpelisibMay 24, 2019PRIORITY212526To treat breast cancercancercancerNOVARTIS
94
2019VyndaqelNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=211996https://www.fda.gov/drugs/resources-information-approved-drugs/drug-trial-snapshots-vyndaqelvyndamax4411NCT01994889tafamidis meglumineMay 3, 2019PRIORITYorphan211996To treat heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adultsheart diseaseFOLDRX PHARMS
95
2019SkyriziBLAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761105https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-skyrizi16065
NCT0202684370, NCT02684357, NCT02672852, NCT02694523, NCT02054481
risankizumab-rzaaApr 23, 2019STANDARD761105To treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapypsoriasisABBVIE
96
2019BalversaNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212018https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-balversa871NCT02365597erdafitinibApr 12, 2019PRIORITY212018To treat adult patients with locally advanced or metastatic bladder cancercancercancerJANSSEN BIOTECH
97
2019EvenityBLAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761062https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-evenity112732-romosozumab-aqqgApr 9, 2019STANDARD761062To treat osteoporosis in postmenopausal women at high risk of fractureosteoporosisAMGEN
98
2019MayzentNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=209884https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-mayzent16511NCT01665144siponimodMar 26, 2019PRIORITY209884To treat adults with relapsing forms of multiple sclerosismultiple sclerosisNORVARTIS
99
2019SunosiNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=211230https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-sunosi6225
NCT02348593, NCT02348606, NCT02348619, NCT02348632, NCT01681121
solriamfetolMar 20, 2019STANDARDorphan211230To treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apneaexcessive sleepinessJAZZ
100
2019ZulressoNDAhttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=211371https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-zulresso2473
NCT02942004, NCT02614541, NCT02942017
brexanoloneMar 19, 2019PRIORITY211371To treat postpartum depression (PPD) in adult womenmental healthSAGE THERAP