Fenfluramine
As of the edition of 20 October 2026, Fenfluramine is a small molecule: marketed, first approved in 2020 (US); acts on HTR1D, HTR2C and SIGMAR1; US protection ends in 2036.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Small molecule
- Brand name
- Fintepla
- First approved
- 25 June 2020 (US)
- Approvals on record
- 5 in 3 regions
- Holder of the most recent approval
- UCB; 3 holders in all
- Withdrawn from market
- 1 January 1997 (in some regions)
- Registered trials
- 26, 3 stopped early
- Disease areas
- Nervous system; Inherited and neonatal; Mental health; Chemically induced; Heart and blood vessels; Nutrition and metabolism
US protection
US protection ends in 2036.
The last listed US drug-substance patent ends in 2036. The application that gives this date is held by UCB.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product5 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
3 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product3 company-target rows are on route B because of Fenfluramine.
See the 3 company-target rows 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 | 4 | 0 | 2 | 0 |
| Phase 1 | 3 | 2 | 0 | 1 |
| Phase 2 | 4 | 2 | 1 | 0 |
| Phase 3 | 11 | 7 | 2 | 2 |
| Phase 4 | 4 | 1 | 2 | 0 |
| All trials | 26 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| UCB | Originator, Applicant and Lead sponsor of trials | 2016 to now |