Ongentys
(Opicapone)ApprovedSmall molecule
Ongentys is a small molecule that works as a COMT Inhibitor.[2] It is being used across 1 indication, with its most advanced program in Approved.[1]
Ongentys is one of 18 small molecule programs targeting Sleep Disorder. It is currently in Approved.
1
Indications
12
Total Trials
1
Active Trials
17
Competitors
4
FDA Applications
NDA/BLA/ANDA regulatory filings
9
Patents
Pipeline
Status by Indication[3][1]
Indication
Competition
Competitive Landscape
21 competitors in Sleep Disorder
#DrugCompanyPhaseTrials
1Diamox
TevaApproved
Epidiolex
Jazz PharmaceuticalsApproved
Dayvigo
EisaiApproved
Rozerem
TakedaApproved
Precedex
MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Approved
Nuvigil
NNuvo Research GmbH
Approved
Kynmobi
SSamson Clinical Operations Pty Ltd
Approved
Zocor
OOrganon and Co
Approved
Rexulti
OtsukaApproved
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
Clinical Trial1 trial
4 more indications
Parkinson disease1 trial
Regulatory
FDA Approval Timeline[4]
Apr 24, 2020
ONGENTYS
NDA NDA212489
Apr 24, 2020
ONGENTYS
NDA NDA212489
Feb 7, 2025
ONGENTYS
NDA NDA212489
Oct 10, 2025
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