Dibotermin Alfa

Summary

Dibotermin Alfa (CHEMBL2109171) is an approved protein (ATC M05BC01); indicated across 8 conditions including bone disorder and tibia fracture.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Protein
• ATC class: M05BC01
• Indications: 8 conditions
• Clinical trials: 27

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL2109171
Name	Dibotermin Alfa
Type	Protein
Max phase	4
ATC	M05BC01

Also known as: Dibotermin, Dibotermin alfa, Dibotermina alfa, Dibotermine alfa, Inductos, Nebotermin, Nebotermina, Nebotermine, Rhbmp-2, Truscient, DIBOTERMIN ALFA

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

8 indications (4 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
bone disorder	4	MONDO:0005381	EFO:0004260
tibia fracture	4	MONDO:0005320	EFO:0003944
bone fracture	2	MONDO:0005315	EFO:0003931
radius fracture	1	MONDO:0005325	EFO:0003957
osteoarthritis	1	MONDO:0005178	MONDO:0005178

3 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 27.

Phase distribution

Phase	Trials
Not specified	17
PHASE2	3
PHASE1	3
PHASE3	2
PHASE4	1
PHASE2/PHASE3	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT00161616	PHASE4	COMPLETED	Study Evaluating InductOs in Diaphyseal Tibia Fractures
NCT00387686	PHASE2/PHASE3	TERMINATED	A Phase 2/3 Multicenter, Controlled Trial Of rhBMP-2/CPM In Tibial Fractures
NCT00707265	PHASE3	COMPLETED	rhBMP-2/CRM/CD HORIZON® Spinal System Pivotal Study
NCT01541345	PHASE3	COMPLETED	Lateral Ridge Augmentation Using Autogenous Bone Blocks or Xenogenic Bone Block Grafts Loaded With Recombinant Human Bone Morphogenic Protein 2
NCT00384358	PHASE2	COMPLETED	Feasibility And Safety Study Of rhBMP-2/CPM For Hip Fractures
NCT00384852	PHASE2	COMPLETED	A Study of rhBMP-2/CPM in Closed Fractures of the Humerus
NCT00752557	PHASE2	COMPLETED	Study Evaluating Changes In Bone Mineral Density (BMD), And Safety Of Rhbmp-2/CPM In Subjects With Decreased BMD
NCT00161629	PHASE1	COMPLETED	Study Evaluating rhBMP-2/CPM in Closed Distal Radius Fractures
NCT00243295	PHASE1	COMPLETED	Study Evaluating rhMBP-2/CPM in Open Wedge Osteotomies
NCT05719181	PHASE1	UNKNOWN	Effect of Recombinant Human Bone Morphogenetic Protein-2 With an Absorbable Collagen Sponge on Stability of Dental Implant: (Split Mouth Randomized Clinical Trial Study.
NCT04670965	Not specified	NOT_YET_RECRUITING	Release Kinetics of rhBMP-2 Using E-PRF as an Autologous Carrier: An In Vitro Analysis
NCT05238740	Not specified	RECRUITING	Comparison of Radiographic Fusion Rate and Clinical Outcome of ALIF and XLIF Performed With Either Recombinant Human Bone Morphogenetic Protein-2 or ViviGen®
NCT06715345	Not specified	ACTIVE_NOT_RECRUITING	Efficacy and Safety of Novosis Putty for Degenerative Lumbar Disease
NCT01491373	Not specified	COMPLETED	Pilot Study of rhBMP-2/ACS/LT-CAGE® for Anterior Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
NCT01491386	Not specified	COMPLETED	Pivotal Study of rhBMP-2/ACS/LT-CAGE® Device for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease
NCT01491425	Not specified	COMPLETED	A Pivotal Study of rhBMP-2/ACS/LT-CAGE® Device for Anterior Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
NCT01491451	Not specified	COMPLETED	A Pilot Study of rhBMP-2/ACS With the INTERFIX™ Device for the AnteriorLumbar Interbody Fusion in Patients With Degenerative Disc Disease
NCT01491464	Not specified	TERMINATED	A Pivotal Study of rhBMP-2/ACS/INTER FIX™ Device for Posterior Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
NCT01491568	Not specified	COMPLETED	rhBMP-2/CRM/CD HORIZON® Spinal System Pilot Study (2-Level)
NCT01494428	Not specified	COMPLETED	A Pilot Study of rhBMP-2/ACS/Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease
NCT01494441	Not specified	COMPLETED	Pilot Study of rhBMP/BCP With or Without the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease
NCT01494454	Not specified	COMPLETED	Clinical Study of rhBMP-2/BCP With the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease
NCT01494493	Not specified	TERMINATED	Pivotal Study of rhBMP-2/ACS/Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease
NCT01495234	Not specified	COMPLETED	Pilot Study of rhBMP-2/BCP in Patients With Spinal Degeneration With Instability Requiring Surgical Fusion
NCT01756144	Not specified	UNKNOWN	rhBMP-2 vs Autologous Bone Grafting for the Treatment of Non-union of the Docking Site in Tibial Bone Transport
NCT05911477	Not specified	UNKNOWN	Recombinant Human Bone Morphogenetic Protein-2(rhBMP-2) in Patients With Osteoporosis After Lumbar Fusion
NCT07240493	Not specified	COMPLETED	BMP Effect on Implant Stability and Marginal Bone Level After Immediate Placement

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).