drug · small molecule
repotrectinib
Marketedupdated 3mo agoby Bristol-Myers Squibb Co🔗 ChEMBL
Approvedcommunity read0 votes
Small molecule drug with a maximum clinical stage of Approval (across all indications), with 3 approved and 1 investigational indication.
indications
investigational
NSCLC
targets
NT-3 growth factor receptorBDNF/NT-3 growth factors receptorCD74-ROS1High affinity nerve growth factor receptorProto-oncogene tyrosine-protein kinase ROS
all catalysts(0)
nothing on the calendar yet
Trials studying repotrectinib
- phase2A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements
- phase1Study to Evaluate the Effect of Repotrectinib on the Drug Levels of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants
- phase3A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)
- phase2A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations
- phase1A Study to Assess the Drug Levels of Repotrectinib in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment
- phase1A Study to Assess the Effect of Voriconazole and Quinidine on the Pharmacokinetics of a Single Dose of Repotrectinib in Healthy Participants
- phase1Phase I Study of Repotrectinib and Osimertinib in NSCLC Patients
- phase1A Phase 1 Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Repotrectinib in Advanced Cancer Patients
Patent cliff
source: FDA Orange Bookfirst barrier falls
Nov 15, 2028
~2.2 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (10)
- Jul 24, 2036method-of-use (U-3961)US 11452725
- Jul 24, 2036method-of-use (U-3755)US 11452725
- Jul 20, 2036method-of-use (U-3755)US 12310968
- Jul 20, 2036method-of-use (U-3755)US 12310968
- Jul 5, 2036compositionUS 10294242
- Jul 5, 2036compositionUS 10294242
- Jul 5, 2036formulationUS 12187739
- Jul 5, 2036formulationUS 12187739
- Jan 23, 2035compositionUS RE50634
- Jan 23, 2035compositionUS RE50634
FDA exclusivities (6)
- Jun 13, 2031ODE-483Orphan Drug (7y)4.8y
- Jun 13, 2031ODE-483Orphan Drug (7y)4.8y
- Nov 15, 2030ODE-455Orphan Drug (7y)4.2y
- Nov 15, 2030ODE*ODE*4.2y
- Nov 15, 2028NCENew Chemical Entity (5y)2.2y
- Nov 15, 2028NCENew Chemical Entity (5y)2.2y
News(0)
no news has mentioned this drug yet
Data sources
last refreshed 9m ago
Found something off?
comments(0)
5-min edit window · permanent after that