drug · small molecule
gedatolisib
pre_registrationupdated 5mo 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(8)
- In first interview as FDA oncology chief, Angelo de Claro vows to ‘continue the innovation’ behind OCE legacyIn his first interview after taking the reins of the FDA’s Oncology Center of Excellence, Angelo de Claro, M.D., is outlining a regulatory agenda that prioritizes organizational strength and contin…fiercebiotech · 23d ago
- 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 5mo 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 · 5mo 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 · 5mo ago
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