Sumatriptan
As of the edition of 20 October 2026, Sumatriptan is a small molecule: marketed, first approved in 1992 (FR); acts on HTR1B and HTR1D.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1997
- Kind
- Small molecule
- Brand name
- Imitrex
- First approved
- 17 November 1992 (FR)
- Approvals on record
- 28 in 5 regions
- Holder of the most recent approval
- Tonix Medicines; 6 holders in all
- Registered trials
- 66, 3 stopped early
- Disease areas
- Nervous system; Injuries; Nutrition and metabolism; Bones, joints and muscles; Hormones; Immune system
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Companies that need a new molecule because of this drug
1 company-target row on route B because of this drug.
Companies on route B for this drug
In the product1 company-target row is on route B because of Sumatriptan.
See the 1 company-target row on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 14 | 11 | 2 | 0 |
| Phase 1 | 20 | 18 | 0 | 1 |
| Phase 2 | 5 | 4 | 0 | 1 |
| Phase 3 | 23 | 21 | 0 | 1 |
| Phase 4 | 4 | 4 | 0 | 0 |
| All trials | 66 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Applicant and Lead sponsor of trials | 1992 to now |
| Pfizer | Later holder and Lead sponsor of trials | 1996 to now |
| Teva | Acquired holder, Later holder and Lead sponsor of trials | 2003 to now |
| Dr. Reddy's | Later holder and Lead sponsor of trials | 2005 to now |
| UCB | Later holder and Lead sponsor of trials | 2007 to now |
| Meridian Medical Technologies Inc Sub King Pharmaceuticals | Acquired holder | 2011 to now |
| Avanir Pharmaceuticals | Later holder | 2016 to now |
| Tonix Medicines | Acquired holder | 2023 to now |
| Endo | Acquired holder | 2024 to now |
| Azurity Pharmaceuticals | Acquired holder | 2026 to now |