drug · small molecule
inavolisib
Marketedupdated 5mo agoby F. Hoffmann-La Roche Ltd🔗 ChEMBL
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 4Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for breast neoplasm and 2 investigational indications.
targets
Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform
all catalysts(3)
Trials studying inavolisib
- phase2A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
- phase1To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer
- phase2Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study
- phase1A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib
- phase3A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
- phase2A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer
- phase3A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study
- phase2A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer
Patent cliff
source: FDA Orange Bookfirst barrier falls
Oct 10, 2029
~3.0 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (14)
- Jun 14, 2038method-of-use (U-4024)US 12410189
- Jun 14, 2038method-of-use (U-4024)US 12410189
- Apr 26, 2038compositionUS 11028100
- Apr 26, 2038compositionUS 11028100
- Jul 1, 2036compositionUS 10851091
- Jul 1, 2036compositionUS 10851091
- Jul 1, 2036method-of-use (U-4024)US 11760753
- Jul 1, 2036method-of-use (U-4024)US 11760753
- Jul 1, 2036compositionUS 9650393
- Jul 1, 2036compositionUS 9650393
- Sep 27, 2030compositionUS 82421044.0y
- Sep 27, 2030compositionUS 82421044.0y
- Sep 27, 2030method-of-use (U-4024)US 83439554.0y
- Sep 27, 2030method-of-use (U-4024)US 83439554.0y
FDA exclusivities (2)
- Oct 10, 2029NCENew Chemical Entity (5y)3.0y
- Oct 10, 2029NCENew Chemical Entity (5y)3.0y
News(1)
- 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
Data sources
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