Gedatolisib
As of the edition of 20 October 2026, Gedatolisib is a small molecule: marketed, first approved in 2026 (US); acts on MTOR, PIK3CA and PIK3CB and 2 more; US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Small molecule
- Brand name
- Revtorpyk
- First approved
- 14 July 2026 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Celcuity
- Registered trials
- 22, 7 stopped early
- Disease areas
- Cancer; Skin and connective tissue; Urinary and reproductive; Pregnancy and women's health; Digestive system; Hormones
US protection
US protection ends in 2031.
The last listed US exclusivity ends in 2031. The application that gives this date is held by Celcuity.
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 product1 listing counts 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
5 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product5 company-target rows are on route B because of Gedatolisib.
See the 5 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
| Gene | Protein | UniProt |
|---|---|---|
| PIK3CD | Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit delta isoform | O00329 |
| PIK3CA | Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform | P42336 |
| PIK3CB | Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit beta isoform | P42338 |
| MTOR | Serine/threonine-protein kinase mTOR | P42345 |
| PIK3CG | Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit gamma isoform | P48736 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 0 | 0 |
| Phase 1 | 9 | 6 | 0 | 1 |
| Phase 2 | 10 | 0 | 3 | 6 |
| Phase 3 | 2 | 0 | 2 | 0 |
| All trials | 22 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Celcuity | Originator and Lead sponsor of trials | 2022 to now |