opicapone
Trade name: Ongentys
Approved
Apr 24, 2020
Opicapone, sold under the brand name Ongentys, is a medication which is administered together with levodopa in people with Parkinson's disease. Opicapone is a catechol-O-methyltransferase (COMT) inhibitor. — Wikipedia
Clinical trial activity
44 trials · 10 clinical orgs · 2 marketing orgs
Earliest trial started Oct 1, 2007 (NCT01520727)
Timeline
2010s
- Jan 1, 2011
Earliest Phase 3 Sponsor(trial)
2020s
- Apr 24, 2020
Neurocrine Biosciences — Earliest FDA Approval
- Apr 24, 2020
Neurocrine Biosciences — Marketing Organization
- Apr 24, 2020
Neurocrine Biosciences — NDA Secondary Org
- Apr 24, 2020
Neurocrine Biosciences — NDA Organization
- Apr 24, 2020
Amneal Pharmaceuticals — Marketing Organization
Indications
Approved for
Mechanism of action
- Catechol O-methyltransferaseANTAGONIST
COMT antagonist
- Catechol O-methyltransferaseINHIBITOR
Catechol O-methyltransferase inhibitor
Selective and reversible inhibitor of COMT. Functions to increase the bioavailability of levodopa by inhibition of COMT, a levodopa metabolizing enzyme.
Approval history
- approvedApr 24, 2020
Chemistry & pharmacology
SMILES
Cc1c(Cl)c(C)[n+]([O-])c(Cl)c1-c1noc(-c2cc(O)c(O)c([N+](=O)[O-])c2)n1- Mol. weight
- 413.17 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- WikipediaOpicapone ↗
- ChEMBLCHEMBL1089318 ↗
Also known as
- 2,5-dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine 1-oxide
- bia 9-1067
- bia 9-1067
- bia 9-1067
- bia 9-1067
- ongentys
- opicapone
- opicapone
- opicapone
- opicapone
- opicapone
- opicapone
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06432309 | N/A | Oct 1, 2022 | University of Ferrara |
| NCT04990284 | Phase 4 | Nov 30, 2021 | Bial |
| NCT04821687 | Phase 4 | Jun 17, 2021 | SK Chemicals |
| NCT04986995 | Phase 4 | Jun 9, 2021 | Bial |
| NCT04978597 | Phase 3 | May 31, 2021 | Bial |
| NCT04986982 | Phase 4 | Feb 25, 2021 | Bial |
| NCT03820037 | Phase 1 | Mar 31, 2019 | Bial |
| NCT04265027 | Phase 1 | Feb 20, 2018 | Bial |
| NCT03496870 | Phase 1 | Feb 8, 2018 | Neurocrine Biosciences, University of California, San Francisco |
| NCT03116295 | Phase 1 | Jun 1, 2017 | Bial |
| NCT03119194 | Phase 1 | Feb 10, 2017 | Bial |
| NCT02847442 | Phase 4 | Nov 23, 2016 | Bial |
| NCT03116308 | Phase 1 | Nov 21, 2014 | Bial |
| NCT02305030 | Phase 1 | Mar 1, 2014 | Bial |
| NCT02305277 | Phase 1 | Mar 1, 2014 | Bial |
| NCT02305017 | Phase 1 | Mar 1, 2014 | Bial |
| NCT02305316 | Phase 1 | Feb 1, 2014 | Bial |
| NCT02305329 | Phase 1 | Feb 1, 2014 | Bial |
| NCT01851850 | Phase 3 | May 1, 2013 | Tel Aviv University |
| NCT02170376 | Phase 1 | Sep 1, 2011 | Bial |
Organizations
Research & Development (10)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Bial | For profit | 40 | 40 | 4 | 2007 |
| Biotrial | For profit | 5 | 0 | 1 | 2007 |
| Algorithme Pharma Inc | For profit | 3 | 0 | 1 | 2008 |
| Covance | For profit | 2 | 0 | 1 | 2009 |
| Neurocrine Biosciences | For profit | 1 | 1 | 1 | 2018 |
| SK Chemicals | For profit | 1 | 1 | 1 | 2021 |
| Tel Aviv University | Academic/Hospital | 1 | 1 | 1 | 2013 |
| University of California, San Francisco | Academic/Hospital | 1 | 0 | 1 | 2018 |
| University of Ferrara | Academic/Hospital | 1 | 1 | 1 | 2022 |
| University of Lisbon | Academic/Hospital | 1 | 0 | 1 | 2009 |
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Amneal Pharmaceuticals | For profit | MKTG | Apr 24, 2020 |
| Neurocrine Biosciences | For profit | MKTG | Apr 24, 2020 |
| Neurocrine Biosciences | For profit | NDA2 | Apr 24, 2020 |
| Neurocrine Biosciences | For profit | NDA | Apr 24, 2020 |