Imetelstat sodium
As of the edition of 20 October 2026, Imetelstat sodium is a drug: marketed, first approved in 2024 (US); acts on TERT; US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Unknown
- Brand name
- Rytelo
- First approved
- 6 June 2024 (US)
- Approvals on record
- 2 in 1 region
- Holder of the most recent approval
- Geron
- Registered trials
- 11, 2 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Heart and blood vessels; Nervous system; Eye
US protection
US protection ends in 2031.
The last listed US exclusivity ends in 2031. The application that gives this date is held by Geron.
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 product4 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
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Imetelstat sodium.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| TERT | Telomerase reverse transcriptase | O14746 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 6 | 5 | 1 | 0 |
| Phase 2 | 4 | 1 | 1 | 2 |
| Phase 3 | 1 | 0 | 1 | 0 |
| All trials | 11 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Geron | Originator and Lead sponsor of trials | 2006 to now |