Dulanermin

Recombinant Human TRAIL (TNF Related Apoptosis Inducing Ligand)Rx: ResearchCompound: Investigational

Also known as: AMG 951, Apo2L, PRO1762, rhApo2L/TRAIL

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

Summary

Dulanermin (rhApo2L/TRAIL) is a recombinant human form of TRAIL developed by Genentech/Amgen. It selectively induces apoptosis in cancer cells by activating death receptors DR4 and DR5. It was investigated in multiple oncology trials, often in combination with chemotherapy or targeted agents, but has not received regulatory approval due to insufficient efficacy in clinical trials.

Mechanism of Action

Binds to death receptors DR4 (TRAIL-R1) and DR5 (TRAIL-R2) on tumor cell surfaces, activating the extrinsic apoptotic pathway via caspase-8 activation, leading to selective apoptosis in cancer cells while sparing normal cells.

Routes of Administration

Intravenous

Goals & Uses

  • Colorectal cancer treatmentOncologyModerate
  • Non-small cell lung cancer treatmentOncologyModerate
  • Synergistic combination with chemotherapyOncologyModerate
  • Apoptosis induction in tumor cellsAnticancerModerate
  • Selective cancer cell killingTargeted TherapyModerate

Contraindications

  • Active severe infectionInfectiousModerate
  • Hepatic impairmentOrgan DysfunctionHigh

Adverse Effects

  • Hepatotoxicity / elevated liver enzymesHepaticUncommon
  • ThrombocytopeniaHematologicUncommonLow platelet count
  • Nausea and vomitingGastrointestinalCommon
  • FatigueGeneralCommonLow energy or tiredness
  • Infusion-related reactionsHypersensitivityUncommon

Drug Interactions

  • BevacizumabLow
  • FOLFOXLow
  • Carboplatin/PaclitaxelLow

Population Constraints

  • Pediatric patientsAgeRelative
  • Patients with pre-existing hepatic diseaseOrgan DysfunctionRelative
  • Pregnant or breastfeeding womenReproductiveRelative

Regulatory Status

  • European UnionInvestigationalNo EMA marketing authorization; investigated under clinical trial frameworks only.
  • United StatesInvestigationalNever received FDA approval; development largely discontinued after Phase II failures.
  • United KingdomInvestigationalNo MHRA approval; status mirrors EU position.

Never received FDA, EMA, or other regulatory approval. Development was largely discontinued after Phase II trials failed to demonstrate adequate clinical benefit in various tumor types including non-small cell lung cancer and colorectal cancer.

Evidence & Sources

No sources recorded yet.

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