NOV-002

Glutathione Disulfide Mimetic / Oxidized Glutathione CompoundRx: ResearchCompound: Investigational

Also known as: GSSG-Pt complex, NovaBay NOV-002, Novelos NOV-002, Oxidized glutathione-cisplatin

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

Summary

NOV-002 is an investigational compound consisting of oxidized glutathione (GSSG) in a molar ratio complex with cisplatin. It was studied primarily as an adjunct to standard chemotherapy in non-small cell lung cancer (NSCLC) and other solid tumors, aiming to reduce myelosuppression, improve immune response, and enhance antitumor efficacy. Despite promising Phase II results, it failed to meet primary endpoints in a Phase III trial (GALES trial) in advanced NSCLC.

Mechanism of Action

NOV-002 is a formulation of oxidized glutathione (GSSG) complexed with cisplatin. It modulates the intracellular glutathione redox ratio (GSH/GSSG), activating redox-sensitive signaling pathways including Ras/ERK and PI3K/Akt, enhancing immune function, protecting normal hematopoietic cells from chemotherapy-induced damage, and potentially sensitizing tumor cells to cytotoxic agents.

Routes of Administration

IntravenousSubcutaneous

Goals & Uses

  • Hematopoietic protection during chemotherapySupportive CareModerate
  • Reduction of chemotherapy-induced myelosuppressionCytoprotectionModerate
  • Immune modulation / restoration of immune functionImmunologyLow
  • Enhancement of antitumor efficacy of chemotherapyOncology / AdjuvantLow
  • Treatment of advanced non-small cell lung cancerOncologyLow

Contraindications

  • Severe renal impairmentOrganModerateKidney function concerns
  • Known hypersensitivity to glutathione or cisplatin componentsAllergyHigh

Adverse Effects

  • Hypersensitivity reactionsImmunologicRare
  • Injection site reactionsLocalCommon
  • NauseaGastrointestinalUncommonFeeling of sickness or urge to vomit
  • FatigueGeneralUncommonLow energy or tiredness

Drug Interactions

  • CarboplatinLow
  • PaclitaxelLow
  • CisplatinModerate

Population Constraints

  • Pediatric patientsAgeRelative
  • Patients with pre-existing renal dysfunctionOrgan ImpairmentRelative
  • Pregnant womenReproductiveRelative

Regulatory Status

  • European UnionUnapprovedNot approved or filed for approval in the European Union.
  • United StatesInvestigationalReceived FDA Fast Track designation for NSCLC; not approved. Development largely discontinued after failed Phase III.
  • United KingdomUnapprovedNot approved in the United Kingdom.

NOV-002 was granted Fast Track designation by the FDA for NSCLC. The Phase III GALES trial did not meet its primary endpoint of overall survival improvement, and further development has largely stalled. It is not approved in any jurisdiction.

Evidence & Sources

No sources recorded yet.

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