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Drug ReportsDibotermin alfa
Dibotermin alfa
Inductos (dibotermin alfa) is a protein pharmaceutical. Dibotermin alfa was first approved as Inductos on 2002-09-09. It has been approved in Europe to treat internal fracture fixation, spinal fusion, and tibial fractures.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
wounds and injuriesD014947
therapeuticsD013812
operative surgical proceduresD013514
Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
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Indications
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Agency Specific
FDA
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Patent Expiration
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ATC Codes
M: Musculo-skeletal system drugs
— M05: Drugs for treatment of bone diseases
— M05B: Drugs affecting bone structure and mineralization
— M05BC: Bone morphogenetic proteins
— M05BC01: Dibotermin alfa
HCPCS
No data
Clinical
Clinical Trials
70 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bone fracturesD050723EFO_0003931T14.8131318
SpondylosisD055009—M47111136
Tibial fracturesD013978EFO_0003944S82.20—112—3
Cleft lipD002971EFO_0003959Q36———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Intervertebral disc degenerationD055959HP_0008419—111—2022
Tooth lossD016388————1——1
AnodontiaD000848HP_0000668K00.0——1——1
Wound healingD014945GO_0042060———1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Spinal diseasesD013122—M45-M4911——910
PeriodontitisD010518EFO_0000649K05.3—1——23
Closed fracturesD005596———1——12
OsteoporosisD010024HP_0000939M81.0—1——12
MalocclusionD008310HP_0000689M26.4—1———1
Ununited fracturesD005599———1———1
Humeral fracturesD006810EFO_0003943S42.3—1———1
Swine diseasesD013553——11———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I101———12
OsteoarthritisD010003EFO_0002506M15-M192————2
BunionD000071378—M21.611————1
Bone diseasesD001847—M89.91————1
Radius fracturesD011885EFO_0003957—1————1
Wrist fracturesD000092503——1————1
Diabetes mellitusD003920HP_0000819E08-E131————1
Hematologic diseasesD006402EFO_0005803D75.91————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SpondylolisthesisD013168EFO_0007493M43.1————44
Spinal fusionD013123——————33
Alveolar bone lossD016301——————33
Spinal stenosisD013130EFO_0007490M48.0————22
PseudarthrosisD011542——————22
Intervertebral disc displacementD007405EFO_1001800—————22
Alveolar ridge augmentationD000540——————22
ScoliosisD012600EFO_0004273M41————11
Pulmonary arterial hypertensionD000081029——————11
Familial primary pulmonary hypertensionD065627—I27.0————11
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDibotermin alfa
INNnebotermin
Description
Inductos (dibotermin alfa) is a protein pharmaceutical. Dibotermin alfa was first approved as Inductos on 2002-09-09. It has been approved in Europe to treat internal fracture fixation, spinal fusion, and tibial fractures.
Classification
Protein
Drug classgrowth factors: bone morphogenetic proteins; growth factors: transforming growth factors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL2109171
ChEBI ID—
PubChem CID—
DrugBank—
UNII IDT472P45MG6 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3 adverse events reported
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