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Drug

Birinapant

Early clinical development
ClassCIAP1/cIAP2 inhibitor
RxNorm1482132ChEMBLCHEMBL3039522UNII6O4Z07B57R
1
Active clinical trials
2
Protein targets
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Birinapant and Intensity Modulated Re-Irradiation Therapy (IMRRT) for Locoregionally Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)

Clinical trial2026-04-29Results posted · ClinicalTrials.gov

An Open-label, Multicenter, Phase 1a/1b Study of Aplitibart (IGM-8444) As a Single Agent and in Combination in Participants with Relapsed, Refractory, or Newly Diagnosed Cancers

Clinical trial2025-01-20Terminated · ClinicalTrials.gov

A Phase I/II, Single Center, Proof-of-Concept Study of Birinapant in Combination With Platinum Based Chemotherapy Targeting Recurrent High Grade Serous Ovarian Carcinomas (HGSOC)

Clinical trial2021-02-01Withdrawn · ClinicalTrials.gov

A Phase 1/2 Multicenter, Single-Arm, Open-Label, Dose-Escalation Study of Birinapant in Combination With Pembrolizumab (KEYTRUDA®) in Patients With Relapsed or Refractory Solid Tumors

Clinical trial2020-02-17Terminated · ClinicalTrials.gov

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Azacitidine With or Without Birinapant With a Single Arm Open-Label Run-In Phase in Subjects With Higher Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

Clinical trial2016-06-01Terminated · ClinicalTrials.gov

A Phase 1B/2A, Open-label, Non-randomized, Multi-arm Study of TL32711 in Combination With Chemotherapy in Subjects With Advanced or Metastatic Solid Tumors

Clinical trial2016-05-30Results posted · ClinicalTrials.gov

A Phase 1b, Open-label, Non-randomized Multicenter Study of Birinapant in Combination With Conatumumab in Subjects With Relapsed Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer

Clinical trial2015-12-01Completed · ClinicalTrials.gov

A Phase 1b/2a, Open-label, Non-randomized Study of Birinapant in Combination With 5-azacitidine in Subjects With Myelodysplastic Syndrome Who Are Naïve, Refractory or Have Relapsed to 5-azacitidine Therapy

Clinical trial2015-11-01Completed · ClinicalTrials.gov

Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Tolerability and Pharmacokinetics Study of Birinapant in Subjects With Chronic Hepatitis B

Clinical trial2015-05-01Terminated · ClinicalTrials.gov

A Phase I-II Open Label Non-Randomized Study Using TL32711 for Patients With Acute Myelogenous Leukemia, Myelodysplastic Syndrome and Acute Lymphoblastic Leukemia

Clinical trial2015-04-01Terminated · ClinicalTrials.gov

Phase II Open Label Non-Randomized Single Agent Study of the SMAC (Second Mitochondrial-Derived Activator of Caspases)-Mimetic Birinapant (TL32711; NSC 756502) in Relapsed Platinum Resistant or Refractory Epithelial Ovarian Cancer, Primary Peritoneal

Clinical trial2014-04-30Terminated · ClinicalTrials.gov

A Phase 1, Open-Label, Non-randomized, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TL32711 in Adults With Refractory Solid Tumors or Lymphoma

Clinical trial2013-03-01Completed · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Birinapant
RxNorm CUI
1482132
ChEMBL ID
CHEMBL3039522
UNII
6O4Z07B57R
Primary mechanism
CIAP1/cIAP2 inhibitor

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Baculoviral IAP repeat-containing protein 3
BIRC3 · Q13489
INHIBITORcIAP1/cIAP2 inhibitor
Baculoviral IAP repeat-containing protein 2
BIRC2 · Q13490
INHIBITORcIAP1/cIAP2 inhibitor

Clinical trials

12 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
12
registered trials across all phases
LATEST COMPLETION 2015
1
Active studies
4
Completed
7
Discontinued
PHASE DISTRIBUTIONn = 12
Phase 15Phase 1 / 25Phase 22

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 1b, Open-label, Non-randomized Multicenter Study of Birinapant in Combination With Conatumumab in Subjects With Relapsed Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer

CompletedPH ITetraLogic Pharmaceuticalsn=272015

A Phase 1b/2a, Open-label, Non-randomized Study of Birinapant in Combination With 5-azacitidine in Subjects With Myelodysplastic Syndrome Who Are Naïve, Refractory or Have Relapsed to 5-azacitidine Therapy

CompletedPH I/IITetraLogic Pharmaceuticalsn=212015

A Phase 1B/2A, Open-label, Non-randomized, Multi-arm Study of TL32711 in Combination With Chemotherapy in Subjects With Advanced or Metastatic Solid Tumors

CompletedPH I/IITetraLogic Pharmaceuticalsn=1762014

A Phase 1, Open-Label, Non-randomized, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TL32711 in Adults With Refractory Solid Tumors or Lymphoma

CompletedPH ITetraLogic Pharmaceuticalsn=502013
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials