Drugs / Gedatolisib
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | REVTORPYK | breast cancer with PIK3CA mutation | 2026-08-26 | “submission of its supplemental New Drug Application (“sNDA”) to the U.S. Food and Drug Administration (“FDA”) for REVTORPYK™” celcuity.com ↗ |
| Approved | US (FDA) | REVTORPYK | — | 2026-07-14 | fda.gov ↗ |
| Filed | US (FDA) | — | HR+/HER2-/PIK3CA wild-type advanced breast cancer | 2026-05-14 | “The FDA has accepted and granted Priority Review of Celcuity’s New Drug Application (“NDA”) for gedatolisib in patients with HR+/HER2-/PIK3CA WT advanced breast cancer” celcuity.com ↗ |
| Filed | US (FDA) | — | HR+/HER2-/PIK3CA wild-type advanced breast cancer | 2026-01-20 | “Following the sNDA submission, Celcuity intends to submit VIKTORIA-1 data for marketing authorization of gedatolisib to other regulatory authorities around the world.” celcuity.com ↗ “In January 2026, the FDA accepted the submission of Celcuity’s New Drug Application (“NDA”) for gedatolisib in HR+/HER2- PIK3CA wild-type (“WT”) ABC.” celcuity.com ↗ “today announced that the U.S. Food and Drug Administration (“FDA”) has accepted for filing its New Drug Application (“NDA”) for gedatolisib” celcuity.com ↗ |
Trials 22
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| Phase 1 | NCT03243331 | Jan 2018 → May 2020 | triple-negative breast carcinoma | Kathy Miller | Completed | No outcome recorded |
| Phase 1 | NCT03065062 | Feb 2017 → Dec 2026 | head and neck cancer, malignant pancreatic neoplasm, squamous cell lung carcinoma | Dana-Farber Cancer Institute | Suspended | No outcome recorded Stop: Business |
| Phase 1 | NCT02684032 | Jun 2016 → Jan 2022 | breast cancer | Celcuity Inc | Completed | No outcome recorded |
| Phase 1 | NCT02626507 | Jan 2016 → Feb 2022 | breast cancer | Hoffman Oncology | Unknown | No outcome recorded |
| Phase 1 | NCT02142920 | Jul → Aug 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02069158 | Apr 2014 → May 2019 | breast cancer, endometrial cancer, head and neck squamous cell carcinoma, non-small cell lung carcinoma +2 | Cristiana Sessa | Completed | No outcome recorded |
| Phase 1 | NCT01920061 | Sep 2013 → Jan 2020 | neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01347866 | Oct 2011 → Dec 2015 | cancer of unknown primary site | Pfizer | Terminated | No outcome recorded |
| Phase 1 | NCT00940498 | Jan 2010 → Aug 2011 | neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 1/25 trials · 1 missed | ||||||
| Phase 1/2 | NCT06190899 | Jan 2024 → Jan 2028 expected | castration-resistant prostate carcinoma | Celcuity Inc | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03911973 | Apr 2019 → Jul 2024 overdue | triple-negative breast carcinoma | Kari Wisinski | Active not recruiting | Missed primary |
| Phase 1/2 | NCT03400254 | Feb → Aug 2019 | breast cancer | Abramson Cancer Center at Penn Medicine | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/2 | NCT02920450 | Sep 2017 → Jan 2019 | non-small cell lung carcinoma | University of Florida | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT01937715 | Feb 2014 → Aug 2015 | colorectal carcinoma | Pfizer | Terminated | No outcome recorded Stop: Business |
| Phase 25 trials | ||||||
| Phase 2 | NCT03698383 | Dec 2019 → Oct 2021 | HER2 positive breast carcinoma | Korean Cancer Study Group | Unknown | No outcome recorded |
| Phase 2 | NCT03675893 | Dec 2018 → Aug 2028 expected | endometrial cancer | Dana-Farber Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT02438761 | Aug 2015 → May 2017 | therapy related acute myeloid leukemia and myelodysplastic syndrome | Institut Curie | Terminated | No outcome recorded |
| Phase 2 | NCT01925274 | Nov 2013 → Apr 2016 | colorectal cancer | Pfizer | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01420081 | Jan 2012 → Apr 2014 | endometrium neoplasm | Pfizer | Terminated | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT06757634 | Jul 2025 → Mar 2029 expected | breast cancer | Celcuity Inc | Recruiting | No outcome recorded |
| Phase 3 | NCT05501886 | Dec 2022 → Jun 2026 overdue | breast cancer | Celcuity Inc | Active not recruiting | Met primary |
| Phase not stated1 trial | ||||||
| — | NCT05134922 | — | female breast carcinoma | Celcuity Inc | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-08-26 | Celcuity Inc | Regulatory Celcuity Submits sNDA to FDA for REVTORPYK™ (gedatolisib) for HR+/HER2-, PIK3CA Mutant Locally Advanced or Metastatic Breast Cancer celcuity.com ↗ |
| 2026-07-14 | Celcuity Inc | Regulatory Celcuity Announces FDA Approval of REVTORPYK™ (gedatolisib) for the Treatment of HR+/HER2-, PIK3CA Wild-Type Locally Advanced or Metastatic Breast Cancer celcuity.com ↗
REVTORPYK is the only inhibitor of class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2 to receive FDA approval. |
| 2026-06-02 | Celcuity Inc | Results Celcuity’s Gedatolisib Combination Regimens Doubled the Likelihood of Survival without Disease Progression or Death Compared to Alpelisib plus Fulvestrant in the PIK3CA Mutant Cohort of the Pivotal Phase 3 VIKTORIA-1 Trial in Patients with HR+/HER2- Advanced Breast Cancer celcuity.com ↗
Gedatolisib plus fulvestrant and palbociclib (the “gedatolisib-triplet”) reduced the risk of disease progression or death by 50% vs. alpelisib plus fulvestrant (HR=0.50; 95% CI: 0.37–0.68; p<0.0001). |
| 2026-05-01 | Celcuity Inc | Results Celcuity's Phase 3 VIKTORIA-1 Trial Achieves Primary Endpoint With Clinically Meaningful Improvement in Progression-Free Survival in PIK3CA Mutant Cohort celcuity.com ↗
The primary efficacy analysis of gedatolisib combined with fulvestrant and palbociclib (the “gedatolisib triplet”) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (“PFS”) compared to alpelisib, a PI3Kα inhibitor, and fulvestrant. |
| 2026-03-09 | Celcuity Inc | Results Celcuity Announces Publication of Results from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Study of Gedatolisib Regimens in HR+/HER2- Advanced Breast Cancer in Journal of Clinical Oncology celcuity.com ↗
The publication is titled “VIKTORIA-1 Trial of Gedatolisib Plus Fulvestrant With or Without Palbociclib in Hormone Receptor-Positive/HER2-/PIK3CA Wild-Type Advanced Breast Cancer.” |
| 2026-01-20 | Celcuity Inc | Regulatory Celcuity Announces FDA Acceptance of New Drug Application for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer celcuity.com ↗
today announced that the U.S. Food and Drug Administration (“FDA”) has accepted for filing its New Drug Application (“NDA”) for gedatolisib in hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”), PIK3CA wild-type advanced breast cancer (“ABC”). |
All press releases naming this drug 10 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 27 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | gedatolisib | “A randomized phase II non-comparative study of PF-04691502 and gedatolisib (PF-05212384) in patients with recurrent endometrial cancer.” PMID 27103175 ↗ Apr 201615“the pan-class-I isoform phosphatidylinositol 3-kinase/mammalian target of rapamycin inhibitor gedatolisib (PF-05212384)” PMID 30256541 ↗ Sep 2018 “PF-05212384 (gedatolisib)” NCT01920061 ↗ |
| Known as | PF-05212384 | “Phase I 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...” NCT03065062 ↗10“Drug: Gedatolisib Participants will receive intravenous (IV) gedatolisib once weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off Other Names: • PF-05212384” NCT06757634 ↗ |
| Known as | PKI-587 | “This is a two-part study of a compound called PF-05212384 (also known as PKI-587).” NCT00940498 ↗ |
| Action | Inhibit | “the intravenous, pan-class I isoform PI3K/mTOR inhibitor PF-05212384” PMID 25652454 ↗ Feb 2015 |
| Modality | Small molecule | “a Small-Molecule, Intravenous, Dual Inhibitor of PI3K and mTOR” PMID 25652454 ↗ Feb 2015 |
| Route | Intravenous | “Intravenous dosing once weekly infusion” NCT00940498 ↗ |
| Target | MTOR | “an inhibitor targeting all class I PI3K isoforms and mTOR complex 1 (mTORC1)-mTOR complex 2 (mTORC2)” PMID 38547892 ↗ Apr 2024 |