drug · small molecule
gedatolisib
pre_registrationupdated 3mo agoby $CELC Celcuity Inc.🔗 ChEMBL
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Small molecule drug with a maximum clinical stage of Phase 3 (across all indications), with 6 investigational indications.
targets
PI3-kinase class ISerine/threonine-protein kinase mTOR
all catalysts(0)
nothing on the calendar yet
Trials studying gedatolisib
- phase2Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer
- phase1Study 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
- phase3Gedatolisib 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)
- phase3Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
- phase2RESOLVE: Abemaciclib + Letrozole +/- Metformin, Zotatifin, or Gedatolisib in Endometrial or Low-Grade Serous Ovarian Cancer
- —Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009
- phase2Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers
News(7)
- Celcuity breast cancer drug misses ‘lofty’ expectations in ASCO-spotlighted trialGedatolisib could “establish a new standard of care” for PIK3CA-mutated breast cancer, an investigator said, but the results nonetheless appeared to disappoint investors.biopharma_dive · 2mo ago
- #ASCO26: Celcuity plans another FDA filing after positive breast cancer readoutCelcuity said a combination regimen with its experimental drug gedatolisib doubled patients' likelihood of survival without disease progression or death in a late-stage breast cancer trial. Executi…endpoints · 2mo ago
- The OncFive: Top Oncology Articles for the Week of 5/3The FDA clears zenocutuzumab in NRG1 fusion+ cholangiocarcinoma, accepts a taletrectinib NDA in ROS1+ NSCLC for review, and more.onclive · 3mo ago
- OncLive Weekly News Quiz (5/8/2026): Test Your Knowledge on Key Breast, Lung, and Pancreatic Cancer UpdatesDid you catch all of this week's top oncology news? Test your knowledge with OncLive's Weekly News Quiz.onclive · 3mo ago
- ASCO 2026 HR+ and HER2+ Breast Cancer Preview: Read up on the Insights to Know Before You GoBreast cancer experts spotlight the abstracts they’re most excited to see at the 2026 ASCO Annual Meeting.onclive · 3mo ago
- Celcuity strengthens case for ASCO-spotlighted breast cancer drugThe new data could support a broader approval submission for a therapy that is already under review and set to be showcased at the year’s biggest meeting for cancer research.biopharma_dive · 3mo ago
- Celcuity's breast cancer win; Odyssey plans $205M IPOCelcuity’s breast cancer drug wins again: The company said two regimens with its experimental drug gedatolisib succeeded in PIK3CA mutant patients as part of its Phase 3 trial. Last year ...endpoints · 3mo ago
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