Drugs / Opicapone
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | ONGENTYS | — | 2020-04-24 | fda.gov ↗ |
| Approved | EU (EMA) | Ongentys | — | 2016-06-24 | europa.eu ↗ |
Trials 38
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 128 trials | ||||||
| Phase 1 | NCT03496870 | Feb → Jul 2018 | Parkinson disease | Neurocrine Biosciences | Completed | No outcome recorded |
| Phase 1 | NCT03119194 | Jan → Apr 2017 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT03116308 | Nov 2014 → Jan 2015 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02305017 | Mar → Apr 2014 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02305030 | Mar → May 2014 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02305329 | Feb → Apr 2014 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02305316 | Feb → Mar 2014 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02170376 | Sep 2011 → Jan 2012 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT01520987 | May 2011 → Nov 2012 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT01532115 | May → Oct 2010 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02101190 | Mar → May 2010 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02169414 | Feb → Jul 2010 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT01532128 | Nov 2009 → Feb 2010 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT01532141 | Nov 2009 → Feb 2010 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT01519284 | Nov 2009 → Feb 2010 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02169440 | Jun → Jul 2009 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT01536366 | Jun → Jul 2009 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT01515891 | May → Jun 2009 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT01533077 | Mar → Oct 2009 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT01533116 | Mar → Aug 2009 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02169466 | Jan → May 2009 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02169453 | Oct 2008 → Jan 2009 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02092168 | Oct 2008 → Jan 2009 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02169895 | Sep → Nov 2008 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02169479 | Sep → Dec 2008 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02071823 | May → Jun 2008 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02071810 | Apr → Sep 2008 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT01520727 | Oct → Dec 2007 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT01568047 | Feb → Jun 2010 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 2 | NCT01568034 | Apr 2009 → Feb 2010 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 34 trials · 2 met primary | ||||||
| Phase 3 | NCT04978597 | May 2021 → Jan 2023 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 3 | NCT01851850 | May 2013 → May 2016 | Parkinson disease | Rabin Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT01568073 | Mar 2011 → Nov 2013 | Parkinson disease | Bial - Portela C S.A. | Completed | Met primary |
| Phase 3 | NCT01227655 | Mar 2011 → Jul 2012 | Parkinson disease | Bial - Portela C S.A. | Completed | Met primary |
| Phase 44 trials | ||||||
| Phase 4 | NCT04821687 | Jun 2021 → Aug 2022 | Parkinson disease | SK Chemicals Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT04986995 | Jun 2021 → Mar 2023 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 4 | NCT04986982 | Feb 2021 → Feb 2024 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 4 | NCT02847442 | Nov 2016 → Jul 2018 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| — | NCT06432309 Comparator | Jul 2022 → Dec 2023 | Parkinson disease | University Hospital of Ferrara | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2020-04-27 | Neurocrine Biosciences | Regulatory Neurocrine Biosciences Announces FDA Approval of Once-Daily ONGENTYS® (opicapone) as an Add-On Treatment for Patients with Parkinson’s Disease Experiencing “Off” Episodes gcs-web.com ↗ |
| 2019-07-10 | Neurocrine Biosciences | Regulatory Neurocrine Biosciences Announces FDA Acceptance of New Drug Application for Opicapone as an Adjunctive Treatment for Patients with Parkinson's Disease gcs-web.com ↗
FDA Accepts New Drug Application for Opicapone, a Once-Daily, Oral, Catechol-O-Methyltransferase (COMT) Inhibitor, as Adjunctive Therapy to Levodopa/Carbidopa |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-12-07 | Impax Laboratories, LLC | Amneal and BIAL Announce U.S. Licensing Agreement for ONGENTYS® (opicapone) amneal.com ↗ |
| 2020-09-14 | Neurocrine Biosciences | Neurocrine Biosciences Announces Once-Daily ONGENTYS® (opicapone) Now Available in the U.S. as an Add-On Treatment for Patients with Parkinson's Disease Experiencing "Off" Episodes gcs-web.com ↗ |
| 2020-04-27 | Neurocrine Biosciences | Neurocrine Biosciences Announces FDA Approval of Once-Daily ONGENTYS® (opicapone) as an Add-On Treatment for Patients with Parkinson’s Disease Experiencing “Off” Episodes gcs-web.com ↗ |
| 2019-07-10 | Neurocrine Biosciences | Neurocrine Biosciences Announces FDA Acceptance of New Drug Application for Opicapone as an Adjunctive Treatment for Patients with Parkinson's Disease gcs-web.com ↗ |
| 2017-02-09 | Neurocrine Biosciences | Neurocrine and BIAL Announce Exclusive North American Licensing Agreement for Opicapone gcs-web.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 40 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Opicapone | “A Study to Evaluate the add-on Efficacy and Safety of Opicapone 50 mg or an Extra Dose of L-DOPA 100 mg for the Treatment of Wearing-off in Patients With PD” NCT04821687 ↗10“BIA 9-1067 (Opicapone, OPC) - 10 mg” NCT01520727 ↗ “BIA 9-1067 (OPC, Opicapone) 5 mg” NCT02071810 ↗ “OPC, opicapone, BIA 9-1067” NCT01520987 ↗ |
| Known as | BIA 9-1067 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02169414 ↗ |
| Known as | Ongentys | ChEMBL registry synonym — accepted as the source's own label CHEMBL1089318 ↗ |
| Known as | Ontilyv | ChEMBL registry synonym — accepted as the source's own label CHEMBL1089318 ↗ |
| Known as | OPC | “Opicapone (OPC) is a third generation catechol O methyltransferase (COMT) inhibitor (COMTi)” NCT04978597 ↗4“BIA 9-1067 (Opicapone, OPC) - 10 mg” NCT01520727 ↗ “BIA 9-1067 (OPC, Opicapone) 5 mg” NCT02071810 ↗ “OPC, opicapone, BIA 9-1067” NCT01520987 ↗ “Opicapone (OPC)” NCT03116308 ↗ |
| Known as | OPC, Opicapone | “OPC, Opicapone” NCT02169466 ↗1“OPC, Opicapone” NCT02071810 ↗ |
| Known as | Opicapona | ChEMBL registry synonym — accepted as the source's own label CHEMBL1089318 ↗ |
| Action | Inhibit | “catechol-O-methyltransferase (COMT) inhibition profiles” NCT01520727 ↗ |
| Modality | Small molecule | — CHEMBL1089318 ↗ |
| Route | Oral | “single-dose oral administration” NCT01515891 ↗ |
| Target | COMT | “catechol-O-methyltransferase (COMT) inhibition profiles” NCT01520727 ↗ |