BoneFDA Approved

BMP-2 (Bone Morphogenetic Protein-2)

Surgical implantation

Overview

BMP-2 is a member of the transforming growth factor-beta superfamily, consisting of a homodimeric protein with each monomer containing approximately 114 amino acids in its mature form. The protein binds to type I and type II serine/threonine kinase receptors on mesenchymal stem cells, activating SMAD-dependent signaling pathways that induce osteoblastic differentiation and bone formation.

Mechanism of Action

Recombinant human BMP-2 is delivered on an absorbable collagen sponge carrier to provide sustained local release at the site of intended bone growth. The molecule is a potent osteoinductive agent capable of inducing ectopic bone formation when implanted in soft tissue..

Research Summary & Key Findings

Recombinant human BMP-2 (INFUSE Bone Graft) received FDA approval in 2002 for anterior lumbar interbody fusion and in 2004 for acute open tibial fractures, based on clinical trials demonstrating equivalent or superior fusion rates compared to autograft. Post-marketing studies and systematic reviews have raised concerns regarding off-label use, including reports of heterotopic ossification, radiculitis, and retrograde ejaculation in certain spinal applications. The product remains widely used in orthopedic and dental bone regeneration procedures under specific indications.

Clinical Status

FDA Approved

BMP-2 (Bone Morphogenetic Protein-2) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.

Administration Routes

Surgical implantation

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Disclaimer: This information is provided for educational and research purposes only. It is not intended as medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before starting any peptide therapy. The Peptide Association does not endorse or recommend any specific treatment protocol.