Overview
Corticotropin (ACTH or adrenocorticotropic hormone) is a polypeptide hormone produced and secreted by the pituitary gland. It is an important player in the hypothalamic-pituitary-adrenal axis.
Indication
For use as a diagnostic agent in the screening of patients presumed to have adrenocortical insufficiency. Purified corticotropin for injection is indicated for a variety of allergic and autoimmune conditions.
Associated Conditions
- Acute Gouty Arthritis
- Allergic Conjunctivitis (AC)
- Ankylosing Spondylitis (AS)
- Atopic Dermatitis
- Chorioretinitis
- Choroiditis
- Infantile Spasms (IS)
- Iridocyclitis
- Iritis
- Keratitis
- Multiple sclerosis exacerbation
- Optic Neuritis
- Polymyositis
- Psoriatic Arthritis
- Rheumatoid Arthritis
- Rheumatoid Arthritis, Juvenile
- Serum Sickness
- Stevens-Johnson Syndrome
- Systemic Lupus Erythematosus
- Anterior eye segment inflammation
- Severe Erythema multiforme
- Severe Psoriasis
- Symptomatic Sarcoidosis
- Systemic Dermatomyositis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/09 | Phase 4 | Recruiting | |||
2022/09/19 | Phase 4 | Active, not recruiting | |||
2022/03/15 | Phase 2 | Active, not recruiting | All India Institute of Medical Sciences, New Delhi | ||
2022/03/11 | Phase 1 | Completed | |||
2021/03/22 | Not Applicable | UNKNOWN | Shanghai 10th People's Hospital | ||
2020/07/08 | Not Applicable | Completed | Chongqing Medical University | ||
2020/03/13 | Not Applicable | UNKNOWN | |||
2019/11/19 | Phase 4 | Completed | |||
2019/09/06 | Phase 4 | Withdrawn | |||
2019/04/05 | Early Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| King Bio Inc. | 57955-2819 | ORAL | 30 [hp_X] in 59 mL | 5/20/2025 | |
| Nutritional Specialties, Inc. | 83027-0123 | ORAL | 15 [hp_C] in 1 mL | 5/15/2025 | |
| ANI Pharmaceuticals, Inc. | 62559-860 | INTRAMUSCULAR, SUBCUTANEOUS | 80 [USP'U] in 1 mL | 6/21/2023 | |
| King Bio Inc. | 57955-9001 | ORAL | 30 [hp_X] in 59 mL | 5/19/2025 | |
| King Bio Inc. | 57955-0762 | ORAL | 30 [hp_X] in 59 mL | 5/20/2025 | |
| Mallinckrodt ARD LLC | 63004-8710 | INTRAMUSCULAR, SUBCUTANEOUS | 80 [USP'U] in 1 mL | 6/30/2023 | |
| King Bio Inc. | 57955-4809 | ORAL | 30 [hp_X] in 118 mL | 5/2/2025 |
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 |
|---|---|---|---|---|---|
| Adrenocorticotropime for Injection | 国药准字H31022101 | 化学药品 | 注射剂(冻干) | 6/23/2020 | |
| Adrenocorticotropime for Injection | 国药准字H12021216 | 化学药品 | 注射剂 | 9/5/2020 |
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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