Ongentys
(Opicapone)ApprovedSmall molecule
Ongentys is a small molecule that works as a COMT Inhibitor.[2] It is being used across 2 indications, with its most advanced program in Approved.[1]
Ongentys is one of 47 small molecule programs targeting Sleep Disorder. It is currently in Approved.
2
Indications
12
Total Trials
1
Active Trials
46
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
9
Patents
Pipeline
Status by Indication[3][1]
Competition
Competitive Landscape
43 competitors in Sleep Disorder
#DrugCompanyPhaseTrials
1Diamox
TevaApproved
Livial
PfizerApproved
Epidiolex
Jazz PharmaceuticalsApproved
Rozerem
TakedaApproved
Dayvigo
EisaiApproved
Precedex
MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Approved
Kynmobi
SSamson Clinical Operations Pty Ltd
Approved
Nuvigil
NNuvo Research GmbH
Approved
Provigil
NNuvo Research GmbH
Approved
Belsomra
CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Approved
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Parkinson's Disease3 trials
4 more indications
Clinical Trial1 trial
Parkinson disease1 trial
Regulatory
FDA Approval Timeline[4]
Apr 24, 2020
ONGENTYS
NDA NDA212489
Sources
References
- [1]
- [2]
- [3]Open Targets Platform — Drug–disease associations for Opicapone. EMBL-EBI & Wellcome Sanger Institute.
- [4]
- [5]
- [6]
Details
Drug Info
Quick Facts
- Mechanism of Action
- COMT Inhibitor[2]
- Modality
- Small molecule[2]
- Highest Phase
- Approved[1]
- Company
- AAmneal Pharmaceuticals, LLC