Clinical Trials
Ongoing Clinical Studies
REVTORPYK (gedatolisib) is currently in development for the first-line treatment of HR+/HER2- locally advanced or metastatic breast cancer and for the second-line treatment of metastatic castration-resistant prostate cancer.
Tumor Type
Breast Cancer
Study Name
VIKTORIA-1
Phase
Phase 3
Status
Enrollment Complete
VIKTORIA-1 is a Phase 3 study evaluating gedatolisib plus fulvestrant with and without palbociclib as a 2nd-line treatment for patients with HR+/HER2- advanced breast cancer previously treated with a CDK4/6 therapy and an aromatase inhibitor.
For more information about the VIKTORIA-1 trial, please visit our clinical trial website. Full details, including eligibility and study locations, are also available on ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT05501886
Tumor Type
Breast Cancer
Study Name
VIKTORIA-2
Phase
Phase 3
Status
Ongoing
VIKTORIA-2 is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant and palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer. Patients will be assigned manually according to their endocrine sensitivity status to either Study 1 (endocrine-resistant) or Study 2 (endocrine-sensitive) and subsequently be randomized 1:1 to either investigational treatment or standard-of-care control.
VIKTORIA-2 is currently enrolling patients at sites across North America, Europe, Latin America and Asia. For more information about the VIKTORIA-2 trial, please visit our clinical trial website. Full details, including eligibility and study locations, are also available on ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT06757634
Tumor Type
Prostate Cancer
Study Name
CELC-G-201
Phase
Phase 1/2
Status
Ongoing
CELC-G-201 is a Phase 1/2 clinical trial evaluating gedatolisib plus darolutamide, an androgen receptor (AR) inhibitor, in patients previously treated with an AR inhibitor for metastatic castration resistant prostate cancer (mCRPC).
CELC-G-201 is currently enrolling patients. Full details, including eligibility and study locations, are available on ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT06190899
Expanded Access Program
(Closed October 1, 2026)
Following the U.S. FDA approval of gedatolisib on July 14, 2026, Celcuity established an Expanded Access Program (EAP) to provide eligible patients with access to therapy while commercial supply was not yet available in the United States. Now that that gedatolisib is commercially available in the U.S., as of October 1, 2026, the EAP will no longer accept new patient requests.
Celcuity is committed to supporting continuity of care and minimizing treatment disruption for patients who were already receiving gedatolisib through the EAP. Celcuity is working closely with patients’ treating physicians and healthcare providers to support their transition to commercially available gedatolisib. New patients should be started through the commercial pathway, via your Specialty Distributor or Biologics Specialty Pharmacy.
For coverage-related questions, please contact us right away at 877-4-CELCUITY (877-423-5284). Celcuity's patient support program (REVTORPYK Support Services) may also be used to identify assistance options so that therapy is not interrupted while an appeal or alternative coverage path is pursued.
