Data updated: Sep 20, 2026
REVTORPYK (gedatolisib) · CELCUITY
Approved 2026-07-14
1
Indication
--
Phase 3 Trials
1
Priority Reviews
0
Years on Market
Details
- Status
- Prescription
- First Approved
- 2026-07-14
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
REVTORPYK Approval History
Original
New Indication
New Form
Label Update
1 FDA actions from 2026 to 2026
What REVTORPYK Treats
1 FDA approvalsOriginally approved for its first indication in 2026 .
- Other (1)
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Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06190899 | CELC-G-201 | Ph 1, Ph 2 | recruiting | Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer |
| NCT03065062 | 16-499 | Ph 1 | suspended | Study of the CDK4/6 Inhibitor Palbociclib (PD-0332991) in Combination With the PI3K/mTOR Inhibitor Gedatolisib (PF-05212384) for Patients With Advanced Squamous Cell Lung, Pancreatic, Head & Neck and Other Solid Tumors |
| NCT05501886 VIKTORIA-1 | CELC-G-301 2021-005235-24 | Ph 3 | active not recruiting | Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1) |
| NCT03675893 | 18-301 | Ph 2 | recruiting | RESOLVE: Abemaciclib + Letrozole +/- Metformin or Gedatolisib in Endometrial Cancer |
| NCT03911973 | BTCRC-BRE18-337 | Ph 1, Ph 2 | active not recruiting | Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers |
| NCT02684032 | B2151009 | Ph 1 | completed | A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer |
| NCT03243331 | IUSCC-0613 | Ph 1 | completed | An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer |
| NCT03400254 GLACIER | UPCC 10117 | Ph 1, Ph 2 | withdrawn | Gedatolisib, Hydroxychloroquine or the Combination for Prevention of Recurrent Breast Cancer ("GLACIER") |
| NCT02920450 results posted | IRB201601181 -A WI211924, UF-STO-LUNG-002 | Ph 1, Ph 2 | terminated | Study of Paclitaxel, Carboplatin, and PF-05212384 in Advanced or Metastatic NSCLC (UF-STO-LUNG-002) |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
REVTORPYK FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.