Vivia
(Nirogacestat)ApprovedSmall molecule
Nirogacestat is used to treat a rare genetic skin condition called epidermolysis bullosa simplex, where the skin is extremely fragile and blisters easily. It helps strengthen the skin by blocking a protein that breaks down skin cell connections.[2] Vivia is currently approved and in use across 10 indications[4].[1]
Vivia is one of 268 small molecule programs targeting Desmoid-type fibromatosis. It is currently in Approved.
10
Indications
20
Total Trials
16
Active Trials
267
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
29
Patents
Pipeline
Status by Indication[4][1]
Indication
Competition
Competitive Landscape
744 competitors in Breast Cancer
#DrugCompanyPhaseTrials
1Vivia
SSpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
Approved
Zolymbus
AbbViePreclinical
MS Contin
HHikma Pharmaceuticals LLC
Preclinical
Duragesic-100
CCephalon
Preclinical
MS Contin
HHikma Pharmaceuticals LLC
Preclinical
Spravato
WWim Janssens
Preclinical
Duragesic
CCephalon
Preclinical
Cortef
PPfizer's Upjohn has merged with Mylan to form Viatris Inc.
Preclinical
Acupan
YYonsei University
Preclinical
Chantix
PPrism Pharmaceuticals
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Multiple Myeloma7 trials
Show 4 more trials
Desmoid Tumor4 trials
Show 1 more trial
Dexamethasone1 trial
Adult1 trial
5 more indications
Ovarian1 trial
Desmoid Fibromatosis1 trial
Regulatory
FDA Approval Timeline[5]
Nov 27, 2023
OGSIVEO
NDA NDA217677
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Vivia drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Nirogacestat. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]FDA Orange Book — Patent and exclusivity data for Vivia. U.S. Food & Drug Administration.
- [7]
Details
Drug Info
Quick Facts
Patent Landscape[6]
Patent Cliff
Aug 18, 2030
Earliest patent expiration — generic entry possible after this date
Patent #Expires
7795447Aug 18, 2030
11820748Aug 9, 2039
10941118Aug 9, 2039
10710966Aug 9, 2039
11845732Aug 9, 2039
24 more patents
11884635Aug 9, 2039
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12297177Aug 9, 2039
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11905255Aug 9, 2039
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