Ivosidenib
As of the edition of 20 October 2026, Ivosidenib is a small molecule: marketed, first approved in 2018 (US); acts on IDH1; US protection ends in 2033.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Small molecule
- Brand name
- Tibsovo
- First approved
- 20 July 2018 (US)
- Approvals on record
- 4 in 4 regions
- Holder of the most recent approval
- Nihon Servier Co., Ltd.; 4 holders in all
- Registered trials
- 61, 6 stopped early
- Disease areas
- Cancer; Blood and lymph; Digestive system; Immune system; Inherited and neonatal; Lungs and airways
US protection
US protection ends in 2033.
The last listed US drug-substance patent ends in 2033. The application that gives this date is held by Servier.
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 product16 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 16 listings behind itRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| IDH1 | Isocitrate dehydrogenase [NADP] cytoplasmic | O75874 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 1 | 2 | 0 |
| Phase 1 | 20 | 9 | 7 | 4 |
| Phase 2 | 27 | 2 | 23 | 2 |
| Phase 3 | 10 | 1 | 9 | 0 |
| All trials | 61 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Agios Pharmaceuticals | Originator and Lead sponsor of trials | 2017 to now |
| Servier | Applicant, Acquired holder and Lead sponsor of trials | 2021 to now |