Eptotermin alfa

Bone Morphogenetic Protein (BMP 7 / OP 1)Rx: PrescriptionCompound: Withdrawn

Also known as: BMP-7, OP-1, OP-1 Implant, OP-1 Putty, Osigraft, rhBMP-7

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

Summary

Eptotermin alfa (rhBMP-7/OP-1) is a recombinant human bone morphogenetic protein-7 formerly used as a biologic bone graft substitute to promote bone healing in long bone nonunions and spinal fusion. It was marketed as OP-1 Putty and OP-1 Implant by Stryker Biotech. Regulatory approvals were under humanitarian device exemptions and limited indications. Stryker withdrew the product from the market around 2009–2012.

Mechanism of Action

Recombinant human osteogenic protein-1 (rhOP-1/BMP-7) that binds BMPR-IA, BMPR-IB, and BMPR-II receptors, activating SMAD signaling pathways to induce differentiation of mesenchymal stem cells into osteoblasts, promoting bone formation and repair.

Routes of Administration

Implantation

Goals & Uses

  • Bone graft substituteOrthopedicModerate
  • Long bone nonunion repairOrthopedic / Bone HealingModerate
  • Posterolateral lumbar spinal fusionOrthopedic / SpineModerate

Contraindications

  • Infection at surgical siteInfectionHigh
  • PregnancyPopulationHighPotential fetal risk or insufficient safety data
  • Skeletal immaturityPatient Age/developmentHigh
  • Known hypersensitivity to BMP-7 or bovine collagenAllergy/HypersensitivityHigh
  • Active malignancy or history of cancer at implant siteOncologyHigh

Adverse Effects

  • Retrograde ejaculationReproductiveUncommon
  • Implant site pain and swellingLocal ReactionCommon
  • Osteolysis / bone resorptionMusculoskeletalUncommon
  • Ectopic bone formationMusculoskeletalUncommon
  • Antibody formation to BMP-7 or bovine collagenImmunologicUncommon

Drug Interactions

  • NSAIDsLowMay increase renal risk in susceptible patients
  • CorticosteroidsModerate

Population Constraints

  • Pediatric patients (skeletally immature)AgeAbsolute
  • Patients with bovine collagen allergyAllergyAbsolute
  • Immunocompromised patientsImmunologicRelative
  • Pregnant womenReproductiveAbsolute

Regulatory Status

  • European UnionWithdrawnApproved: Treatment of tibial nonunions in adults (Osigraft)EMA approved Osigraft (eptotermin alfa) for tibial nonunions; marketing authorization subsequently lapsed/withdrawn.
  • United StatesWithdrawnApproved: Recalcitrant long bone nonunions (HDE), Posterolateral lumbar spinal fusion as alternative to autograft in patients with failed previous fusion (HDE)Approved under Humanitarian Device Exemption (HDE). Stryker Biotech withdrew the product voluntarily from the US market circa 2009–2012 amid regulatory and legal issues.
  • United KingdomWithdrawnApproved: Tibial nonunionsFollowed EU authorization; no longer marketed.

Received FDA Humanitarian Device Exemption (HDE) approval for recalcitrant long bone nonunions and later for posterolateral lumbar spinal fusion in the US. EMA granted conditional/limited authorization in some EU jurisdictions. Stryker Biotech voluntarily withdrew the product from the US market; criminal charges against Stryker Biotech executives related to off-label promotion contributed to market exit.

Evidence & Sources

No sources recorded yet.

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