THERAPY DOSSIER · th-85f3a49543bd

Recombinant human bone morphogenetic protein-2 (rhBMP-2)

Biologic · Recombinant human BMP-2 protein; ChEMBL get_mechanism returned SIX records, all AGONIST, all direct_interaction and disease_efficacy true (mec_id 9669 BMPR1A CHEMBL5275, 9677 BMPR1B CHEMBL5476, 9672 BMPR2 CHEMBL5467, 9680 ACVR1 CHEMBL5903, 9678 ACVR2A CHEMBL5616, 9671 ACVR2B CHEMBL5466). USAN stem -ermin (-otermin), 2001, defined as bone morphogenetic protein growth factors. ATC M05BC01. EMA cross-references Inductos (human) and Truscient (veterinary). Approved 2002, withdrawn_flag FALSE, black_box_warning FALSE, therapeutic_flag TRUE, dosed_ingredient TRUE.

Approved for trauma Suggest a correction

Evidence & regulatory context

Mechanism: Recombinant human BMP-2 protein; ChEMBL get_mechanism returned SIX records, all AGONIST, all direct_interaction and disease_efficacy true (mec_id 9669 BMPR1A CHEMBL5275, 9677 BMPR1B CHEMBL5476, 9672 BMPR2 CHEMBL5467, 9680 ACVR1 CHEMBL5903, 9678 ACVR2A CHEMBL5616, 9671 ACVR2B CHEMBL5466). USAN stem -ermin (-otermin), 2001, defined as bone morphogenetic protein growth factors. ATC M05BC01. EMA cross-references Inductos (human) and Truscient (veterinary). Approved 2002, withdrawn_flag FALSE, black_box_warning FALSE, therapeutic_flag TRUE, dosed_ingredient TRUE.
Target: BMPR1A (CHEMBL5275); BMPR1B (CHEMBL5476); BMPR2 (CHEMBL5467); ACVR1 (CHEMBL5903); ACVR2A (CHEMBL5616); ACVR2B (CHEMBL5466)
Injury models: Spinal cord injury · Wound
Reported indication: Bone regeneration: anterior lumbar interbody spinal fusion (2002) and acute open tibial shaft fractures (2004); dibotermin alfa (InFUSE/Inductos)
First approval: 2002
Development stage: Approved for acute open tibial fracture and lumbar spinal fusion; safety-caveated/narrowed
ChEMBL record: CHEMBL2109171 ↗
ChEMBL max phase: 4 / 4 (development scale, not regulatory approval)
Synonyms: Dibotermin alfa; rhBMP-2; Inductos; Truscient; Nebotermin; INFUSE Bone Graft
Note: Approved as INFUSE Bone Graft (FDA PMA P000058, 2002) for anterior lumbar interbody fusion and, in 2004, acute open tibial shaft fractures. A 2008 FDA Public Health Notification warned of life-threatening neck swelling from off-label cervical-spine use. Its approval pre-dates the rodent studies catalogued here, so it is not a therapy that emerged from this preclinical literature.

Clinical trials 9

1 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.

NCT02609074 ↗Injury indicationPHASE4completed

Trial title not recorded

Bone Fracture

Enrolment: 81 · Results not recorded

NCT00707265 ↗PHASE3completed

Trial title not recorded

Degenerative Disc Disease

Enrolment: 463 · Results not recorded

NCT01634308 ↗PHASE3completed

Trial title not recorded

Alveolar bone regeneration after maxillary sinus floor augmentation

Enrolment not recorded · Results not recorded

NCT01415908 ↗PHASE3terminated

Trial title not recorded

Lumbar Spine Degeneration

Enrolment: 15 · Results not recorded

NCT01491386 ↗NAcompleted

Trial title not recorded

Degenerative Disc Disease

Enrolment: 279 · Results not recorded

NCT01764906 ↗NAunknown

Trial title not recorded

Posterolateral Fusion

Enrolment: 90 · Results not recorded

NCT06715345 ↗NAactive not recruiting

Trial title not recorded

Degenerative Lumbar Diseases

Enrolment: 48 · Results not recorded

NCT01430299 ↗NAcompleted

Trial title not recorded

Stenosis · Spondylosis · Degenerative Changes

Enrolment: 43 · Results not recorded

NCT01491399 ↗NAcompleted

Trial title not recorded

Degenerative Cervical Disc Disease

Enrolment: 33 · Results not recorded

Preclinical evidence 3

1 studies reported at therapy level; 3 evidence entries itemised.

PMID 22204004 ↗2011Reported harm

Alterations in recovery from spinal cord injury in rats treated with recombinant human bone morphogenetic protein-2 for posterolateral arthrodesis.

RatSpinal cord injuryHemisection / partialSprague-DawleyFemalen = 52 rats underwent T10 dorsal hemisection, with 24 in the ve…Posterolateral spinal application at the level of the spinal cord injuryAt the time of the T10 dorsal hemisection surgery

Model: T10 dorsal hemisection spinal cord injury with posterolateral spinal application at the level of injury

At one week rhBMP-2-treated rats showed significantly increased reactive astrocyte, macrophage-microglia and fibroblast immunoreactivity around the lesion and increased chondroitin sulfate proteoglycan staining relative to controls, with similar differences persisting at six weeks. Acutely, rhBMP-2…

Extraction: extract · Subtype source: rule · Supplied extraction confidence: 0.75. Machine-extracted fields require source verification.

PMID 20930356 ↗2010

Histological and radiographic evaluation of the muscle tissue of rats after implantation of bone morphogenic protein (rhBMP-2) in a scaffold of inorganic bone and after stimulation with low-power laser light

RatWound

Extraction: mesh. Machine-extracted fields require source verification.

PMID 19018606 ↗2009

rhBMP-2 modulation of gene expression in infected segmental bone defects

RatSpinal cord injury

Extraction: mesh. Machine-extracted fields require source verification.

Record at a glance

Study window: 2009–2011
Corpus tranches: 1980-1989 · 1990-2010 · 2011-2020
Species: Rat
Physical-trauma evidence: Present
Repurposed: Approval pre-dates corpus studies
Combination: Not flagged
Withdrawal flag: Not flagged
Dataset: 2026-08-25

Safety narrative

Reported finding

FDA 2008 Public Health Notification: life-threatening cervical airway/soft-tissue swelling with off-label cervical use; indication narrowed to when autograft not feasible; ongoing efficacy-vs-autograft and cancer-risk debate

The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.

Sources & provenance

ChEMBL (EMBL-EBI) CHEMBL2109171 max_phase 4, approved 2002
FDA InFUSE approvals: ALIF 2002, acute open tibial shaft fracture 4 May 2004 (payer policy summaries)
FDA 2008 Public Health Notification (off-label cervical use)

How records are classified

Loading the evidence…

Recombinant human bone morphogenetic protein-2 (rhBMP-2)