Interferon gamma-1b
Actimmune (interferon gamma-1b) is a protein pharmaceutical. Interferon gamma-1b was first approved as Actimmune on 1999-02-25. It is used to treat bacterial infections, brain neoplasms, chronic hepatitis c, colorectal neoplasms, and cryoglobulinemia amongst others in the USA.
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Commercial
Therapeutic Areas
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Trade Name
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Actimmune
Drug Products
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EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Interferon gamma-1b
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Actimmune | interferon gamma-1b | Horizon Therapeutics Public | N-103836 RX | 1999-02-25 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| actimmune | Biologic Licensing Application | 2025-04-17 |
Indications
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EMA
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
interferon gamma-1b, Actimmune, Horizon Therapeutics Ireland DAC | |||
| 2107-02-10 | Orphan excl. | ||
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Clinical
Clinical Trials
370 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 5 | 6 | 1 | 5 | 48 | 63 |
| Infections | D007239 | EFO_0000544 | — | 8 | 10 | 2 | 3 | 20 | 37 |
| Latent tuberculosis | D055985 | — | Z22.7 | — | — | 2 | 5 | 23 | 30 |
| Communicable diseases | D003141 | — | — | 6 | 7 | 1 | 1 | 14 | 25 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 5 | 7 | — | 4 | 6 | 21 |
| Hepatitis | D006505 | — | K75.9 | 2 | 5 | 3 | 4 | 7 | 20 |
| Covid-19 | D000086382 | — | U07.1 | 1 | 1 | 1 | 2 | 14 | 19 |
| Hepatitis c | D006526 | — | B19.2 | 4 | 7 | 2 | 2 | 6 | 17 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 2 | 3 | 3 | 4 | 6 | 17 |
| Chronic hepatitis | D006521 | — | K73.9 | 4 | 6 | 1 | 3 | 4 | 14 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 6 | 3 | 3 | — | 3 | 15 |
| Melanoma | D008545 | — | — | 7 | 6 | 3 | — | — | 13 |
| Pneumonia | D011014 | EFO_0003106 | J18 | 1 | 3 | 2 | — | 5 | 11 |
| Fibrosis | D005355 | — | — | 3 | 5 | 3 | — | 1 | 10 |
| Lymphoma | D008223 | — | C85.9 | 2 | 5 | 2 | — | 1 | 8 |
| Carcinoma | D002277 | — | C80.0 | 3 | 4 | 2 | — | — | 7 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 3 | 4 | 2 | — | 1 | 7 |
| Sepsis | D018805 | EFO_0001420 | A41.9 | — | 3 | 2 | — | 3 | 7 |
| Idiopathic pulmonary fibrosis | D054990 | — | J84.112 | 1 | 2 | 4 | — | — | 7 |
| Friedreich ataxia | D005621 | Orphanet_95 | G11.11 | — | 3 | 3 | — | — | 6 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | 2 | 3 | — | — | 4 | 9 |
| Virus diseases | D014777 | — | B34 | 3 | 3 | — | — | 6 | 9 |
| Pulmonary tuberculosis | D014397 | EFO_1000049 | A15 | 2 | 3 | — | — | 5 | 8 |
| Mycobacterium infections | D009164 | — | A31.9 | 2 | 3 | — | — | 3 | 8 |
| Myelodysplastic syndromes | D009190 | — | D46 | 5 | 1 | — | — | 1 | 7 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 5 | 1 | — | — | 1 | 7 |
| Leukemia | D007938 | — | C95 | 5 | 1 | — | — | 1 | 6 |
| Colorectal neoplasms | D015179 | — | — | 1 | 4 | — | — | — | 5 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 3 | 3 | — | — | — | 5 |
| Adenoviridae infections | D000257 | EFO_1001259 | B34.0 | 5 | 4 | — | — | — | 5 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | 2 | — | — | — | 3 | 5 |
| Asthma | D001249 | EFO_0000270 | J45 | 1 | — | — | — | 2 | 3 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 2 | — | — | — | 1 | 3 |
| Hematopoietic stem cell transplantation | D018380 | — | — | 2 | — | — | — | 1 | 3 |
| Immune system diseases | D007154 | — | D89.9 | 1 | — | — | — | 1 | 2 |
| Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | 1 | — | — | — | 1 | 2 |
| Rheumatic diseases | D012216 | — | M79.0 | 1 | — | — | — | 1 | 2 |
| Collagen diseases | D003095 | — | — | 1 | — | — | — | 1 | 2 |
| T-cell lymphoma | D016399 | — | — | 2 | — | — | — | — | 2 |
| Large-cell lymphoma anaplastic | D017728 | — | C84.6 | 2 | — | — | — | — | 2 |
Show 44 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney transplantation | D016030 | — | — | — | — | — | — | 6 | 6 |
| Respiratory tract infections | D012141 | — | J06.9 | — | — | — | — | 5 | 5 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | — | 3 | 3 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 2 | 2 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 2 | 2 |
| Pulmonary arterial hypertension | D000081029 | — | — | — | — | — | — | 2 | 2 |
| Autonomic nervous system diseases | D001342 | EFO_0009532 | G90 | — | — | — | — | 2 | 2 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | — | — | — | 2 | 2 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | — | — | 2 | 2 |
| Mycobacterium tuberculosis | D009169 | NCBITaxon_1773 | — | — | — | — | — | 2 | 2 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Interferon gamma-1b |
| INN | — |
| Description | Actimmune, Betaferon, Extavia (interferon gamma-1b) is a protein pharmaceutical. Interferon gamma-1b was first approved as Actimmune on 1995-11-30. It is used to treat bacterial infections, brain neoplasms, chronic hepatitis c, colorectal neoplasms, and cryoglobulinemia amongst others in the USA. It has been approved in Europe to treat multiple sclerosis. |
| Classification | Protein |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201564 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00033 |
| UNII ID | — |
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Actimmune – Horizon Therapeutics Public
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Actimmune – Intermune
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Safety
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1,861 adverse events reported
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