Imetelstat
As of the edition of 20 October 2026, Imetelstat is a drug: marketed, first approved in 2024 (US); acts on TERT; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Unknown
- Brand name
- Rytelo
- First approved
- 6 June 2024 (US)
- Approvals on record
- 3 in 2 regions
- Holder of the most recent approval
- Geron; 2 holders in all
- Registered trials
- 11, 2 stopped early
- Disease areas
- Blood and lymph; Cancer; Immune system; Heart and blood vessels; Lungs and airways
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
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.
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 not stated | 1 | 0 | 0 | 0 |
| Phase 1 | 3 | 0 | 1 | 2 |
| Phase 2 | 6 | 5 | 1 | 0 |
| Phase 3 | 1 | 0 | 1 | 0 |
| All trials | 11 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Geron | Originator, Applicant and Lead sponsor of trials | 2024 to now |