frovatriptan
Trade name: frova
Approved
Nov 8, 2001
Frovatriptan succinate (trade name Frova) is a selective 5-hydroxytryptamine1 (5-HT1B/1D) receptor subtype agonist, and is used for the treatment of migraine attacks with or without aura in adults. Frovatriptan has no significant effects on GABAA mediated channel activity and has no significant affinity for benzodiazepine binding sites. Frovatriptan is believed to act on extracerebral, intracranial arteries and to inhibit excessive dilation of these vessels in migraine. Serious but rare cardiac events have been reported in patients with risk factors predictive of coronary artery disease (CAD). These include coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia and ventricular fibrillation. — NCATS
Clinical trial activity
10 trials · 14 clinical orgs · 9 marketing orgs
Earliest trial started Jun 1, 2001 (NCT00644033)
Timeline
2000s
- Jan 1, 2001
Endo Pharmaceuticals — Earliest Phase 3 Sponsor(trial)
- Nov 8, 2001
Elan Pharmaceuticals — Earliest FDA Approval
- Nov 8, 2001
Endo Pharmaceuticals — NDA Secondary Org
- Nov 8, 2001
Elan Pharmaceuticals — NDA Organization
- Nov 8, 2001
Bristol-Myers Squibb — NDA Secondary Org
- Nov 8, 2001
Endo Pharmaceuticals — Marketing Organization
2010s
- Jan 1, 2010
Earliest Phase 2 Sponsor(trial)
- Aug 28, 2014
Mylan — Marketing Organization
- Aug 28, 2014
PHARMOBEDIENT — Marketing Organization
- Mar 11, 2016
Glenmark Pharmaceuticals — Marketing Organization
- Nov 6, 2018
Amneal Pharmaceuticals — Marketing Organization
2020s
- Apr 6, 2022
Renata — Marketing Organization
- Apr 16, 2025
Leading Pharma Llc — Marketing Organization
Indications
Approved for
Studied for
Mechanism of action
HTR1B agonist
Selective
HTR1D agonist
Selective
Approval history
- approvedNov 8, 2001
Chemistry & pharmacology
SMILES
CN[C@@H]1CCc2[nH]c3ccc(C(N)=O)cc3c2C1.O.O=C(O)CCC(=O)O- Mol. weight
- 379.41 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL2138684 ↗
- WikipediaFrovatriptan ↗
- NCATSH82Q2D5WA7 ↗
- ChEMBLCHEMBL1279 ↗
- ChEMBLCHEMBL1200371 ↗
Also known as
- 3-methylamino-6-carboxamido-1,2,3,4-tetrahydrocarbazole
- allegro
- frova
- frova
- frova
- frova
- frovatriptan
- frovatriptan
- frovatriptan
- frovatriptan
- frovatriptan
- frovatriptan
- frovatriptan
- frovatriptan
- frovatriptan
- frovatriptan
- frovatriptan succinate
- frovatriptan succinate
- frovatriptan succinate
- frovatriptan succinate
- frovatriptan succinate
- frovatriptan succinate hydrate
- frovelan
- migard
- migard
- mylatrip
- (r)-frovatriptan
- sb 209509
- sb 209509
- sb-209509ax
- sb-209509ax
- sb-209509-ax
- sb-209509-ax
- vml251
- vml251
- vml-251
- vml-251
- vml-251
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT01619176 | N/A | Oct 1, 2012 | Chinese Academy of Medical Sciences, Jiao Tong University |
| NCT01044251 | Phase 2 | Jan 1, 2010 | University of Calgary |
| NCT00846495 | Phase 4 | Aug 1, 2009 | Alder Biopharmaceuticals, Clinvest, Endo Pharmaceuticals |
| NCT00700128 | N/A | Jun 1, 2008 | Endo Pharmaceuticals, Scott and White Healthcare, Texas A&M University |
| NCT00440232 | N/A | Jul 1, 2007 | Thomas Jefferson University |
| NCT00821483 | Phase 3 | Nov 1, 2006 | SK Chemicals, University of Ulsan |
| NCT00904098 | Phase 4 | Sep 1, 2005 | Endo Pharmaceuticals |
| NCT00475514 | Phase 3 | Oct 1, 2004 | Endo Pharmaceuticals |
| NCT01035983 | Phase 3 | Dec 1, 2003 | City of London Migraine Clinic, Endo Pharmaceuticals, Vernalis |
| NCT00644033 | Phase 3 | Jun 1, 2001 | Elkind Headache Center, Endo Pharmaceuticals, Vernalis |
Organizations
Research & Development (14)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Endo Pharmaceuticals | For profit | 6 | 4 | 3 | 2001 |
| Vernalis | For profit | 2 | 0 | 1 | 2001 |
| Alder Biopharmaceuticals | For profit | 1 | 0 | 1 | 2009 |
| Chinese Academy of Medical Sciences | Academic/Hospital | 1 | 1 | 1 | 2012 |
| City of London Migraine Clinic | Academic/Hospital | 1 | 0 | 1 | 2003 |
| Clinvest | For profit | 1 | 1 | 1 | 2009 |
| Elkind Headache Center | Academic/Hospital | 1 | 0 | 1 | 2001 |
| Jiao Tong University | Academic/Hospital | 1 | 0 | 1 | 2012 |
| Scott and White Healthcare | Academic/Hospital | 1 | 1 | 1 | 2008 |
| SK Chemicals | For profit | 1 | 1 | 1 | 2006 |
| Texas A&M University | Academic/Hospital | 1 | 0 | 1 | 2008 |
| Thomas Jefferson University | Academic/Hospital | 1 | 1 | 1 | 2007 |
| University of Calgary | Academic/Hospital | 1 | 1 | 1 | 2010 |
| University of Ulsan | Academic/Hospital | 1 | 0 | 1 | 2006 |
Marketing (11)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Amneal Pharmaceuticals | For profit | MKTG | Nov 6, 2018 |
| Bristol-Myers Squibb | For profit | NDA2 | Nov 8, 2001 |
| Elan Pharmaceuticals | For profit | NDA | Nov 8, 2001 |
| Endo Pharmaceuticals | For profit | NDA2 | Nov 8, 2001 |
| Endo Pharmaceuticals | For profit | MKTG | Nov 8, 2001 |
| Glenmark Pharmaceuticals | For profit | MKTG | Mar 11, 2016 |
| Leading Pharma Llc | For profit | MKTG | Apr 16, 2025 |
| Mylan | For profit | MKTG | Aug 28, 2014 |
| Mylan | For profit | SYN | Aug 28, 2014 |
| PHARMOBEDIENT | For profit | MKTG | Aug 28, 2014 |
| Renata | For profit | MKTG | Apr 6, 2022 |