Birinapant

SMAC Mimetic (IAP Antagonist)Rx: InvestigationalCompound: Investigational

Also known as: Birinapant, TL32711

Educational Only — Not medical advice. Consult a qualified clinician before using any peptide.

Source Birinapant at Peptiology

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Summary

Birinapant (TL32711) is a bivalent small‑molecule mimetic of the SMAC protein that antagonizes IAPs. It is being evaluated in early‑phase clinical trials for solid tumors and hematologic malignancies, often in combination with chemotherapy or immune‑checkpoint inhibitors.

Mechanism of Action

Binds to cellular inhibitor of apoptosis proteins (cIAP1, cIAP2) and XIAP, promoting their autoubiquitination and degradation, thereby facilitating caspase activation and tumor cell apoptosis.

Routes of Administration

Intravenous

Goals & Uses

  • Solid tumor oncologyOncologyModerate
  • Solid tumor treatmentOncologyLow
  • Sensitization to chemotherapyCombination Oncology TherapyModerate
  • Hematologic malignanciesOncologyModerate
  • Apoptosis induction in cancer cellsOncologyModerate
  • Treatment of myelodysplastic syndromes (MDS)OncologyModerate
  • Treatment of acute myeloid leukemia (AML)Hematologic MalignancyModerate

Contraindications

  • Severe hepatic impairmentOrganModerateLiver function concerns
  • Active uncontrolled infectionInfectious DiseaseModerate
  • Known hypersensitivity to birinapant or its componentsAllergyHigh

Adverse Effects

  • ThrombocytopeniaHematologicUncommonLow platelet count
  • Facial palsy (Bell's palsy / cranial nerve VII palsy)NeurologicalUncommon
  • Nausea and vomitingGastrointestinalCommon
  • NeutropeniaHematologicUncommonLow neutrophil count
  • NauseaGastrointestinalCommonFeeling of sickness or urge to vomit
  • FatigueGeneralCommonLow energy or tiredness
  • Increased liver enzymes (transaminitis)HepaticUncommon
  • Infusion-related reactionsHypersensitivityUncommon

Drug Interactions

  • CYP3A4 inhibitorsModerate
  • TNF-alpha-inducing agentsModerate
  • CYP3A4 inhibitors/inducersLow
  • 5-Azacitidine (Azacitidine)Low

Population Constraints

  • PregnancyReproductive SafetyAbsolute
  • Severe renal impairmentOrgan ImpairmentRelative
  • Pediatric patientsAgeRelative
  • Pregnant womenReproductiveRelative
  • Patients with pre-existing cranial nerve disordersNeurologicalRelative
  • PediatricsAgeRelative

Regulatory Status

  • European UnionInvestigationalClinical trial authorization in multiple member states.
  • United StatesInvestigationalIND for oncology trials.
  • United KingdomInvestigationalNot approved by MHRA; available only within clinical trial settings.

Not approved by FDA, EMA, or MHRA; currently holds investigational new drug (IND) status in the United States and equivalent clinical trial authorizations in the EU.

Evidence & Sources

No sources recorded yet.

Frequently Asked Questions

What is Birinapant?

Birinapant (TL32711) is a bivalent small‑molecule mimetic of the SMAC protein that antagonizes IAPs. It is being evaluated in early‑phase clinical trials for solid tumors and hematologic malignancies, often in combination with chemotherapy or immune‑checkpoint inhibitors.

What is Birinapant used for?

Birinapant is educationally associated with: Solid tumor oncology, Solid tumor treatment, Sensitization to chemotherapy, Hematologic malignancies, Apoptosis induction in cancer cells, Treatment of myelodysplastic syndromes (MDS), Treatment of acute myeloid leukemia (AML). Educational only — not medical advice.

How is Birinapant administered?

Recorded routes of administration: Intravenous.

What are the potential side effects of Birinapant?

Reported adverse effects include: Thrombocytopenia, Facial palsy (Bell's palsy / cranial nerve VII palsy), Nausea and vomiting, Neutropenia, Nausea, Fatigue, Increased liver enzymes (transaminitis), Infusion-related reactions. This list is not exhaustive — consult a qualified clinician.

Who should avoid Birinapant?

Recorded contraindications: Severe hepatic impairment, Active uncontrolled infection, Known hypersensitivity to birinapant or its components. Consult a qualified clinician before use.