Overview
Human Interferon gamma-1b (140 residues), produced from E. coli. Production of Actimmune is achieved by fermentation of a genetically engineered Escherichia coli bacterium containing the DNA which encodes for the human protein. Purification of the product is achieved by conventional column chromatography. The sequence displayed is a cDNA sequence which codes for human interferon gamma, as described by Gray et. al. and not specifically interferon gamma 1b.
Indication
Interferon gamma-1b is used for the treatment of Chronic granulomatous disease and Osteopetrosis.
Associated Conditions
- Chronic Granulomatous Disease (CGD)
- Severe, malignant Osteopetrosis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/14 | Phase 3 | Recruiting | Centre Hospitalier Et Universitaire De Limoges | ||
2024/11/19 | Phase 2 | Not yet recruiting | |||
2024/07/31 | Phase 2 | Recruiting | Sawa Ito, MD | ||
2021/07/27 | Phase 2 | Recruiting | |||
2018/11/20 | Phase 1 | Terminated | |||
2018/06/07 | N/A | Completed | |||
2016/01/28 | Phase 2 | Completed | |||
2015/10/22 | Phase 2 | Completed | |||
2015/01/15 | Phase 1 | Terminated | |||
2013/10/18 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Horizon Therapeutics USA, Inc. | 75987-111 | SUBCUTANEOUS | 100 ug in 0.5 mL | 10/12/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| IMUKIN Interferon Gamma-1b recombinant human (2 million IU)/100microgram/0.5mL | 48404 | Link Medical Products Pty Ltd T/A Link Pharmaceuticals | Medicine | A | 4/8/1994 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| IMUKIN 100 microgramos SOLUCION INYECTABLE | Clinigen Healthcare B.V. | 60113 | SOLUCIÓN INYECTABLE | Diagnóstico Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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