Overview
No overview information available.
Indication
No indication information available.
Associated Conditions
- Acquired hemolytic anemias
- Acute Gouty Arthritis
- Ankylosing Spondylitis (AS)
- Berylliosis
- Bullous dermatitis herpetiformis
- Congenital Adrenal Hyperplasia (CAH)
- Congenital Hypoplastic Anemia
- Dermatomyositis (DM)
- Edema of the cerebrum
- Hypercalcemia
- Idiopathic Nephrotic Syndrome
- Immune Thrombocytopenia (ITP)
- Leukemias
- Lymphoma
- Mycosis Fungoides (MF)
- Ocular Inflammatory Disease
- Ophthalmia, Sympathetic
- Pemphigus
- Polymyositis
- Primary adrenocortical insufficiency
- Proteinuria
- Psoriatic Arthritis
- Pure Red Cell Aplasia
- Regional Enteritis
- Rheumatoid Arthritis
- Rheumatoid Arthritis, Juvenile
- Secondary adrenocortical insufficiency
- Secondary thrombocytopenia
- Stevens-Johnson Syndrome
- Systemic Lupus Erythematosus
- Temporal Arteritis
- Trichinosis
- Tuberculous Meningitis
- Ulcerative Colitis
- Uveitis
- Acute rheumatic carditis
- Disseminated Pulmonary Tuberculosis (TB)
- Exfoliative erythroderma
- Fulminating Pulmonary Tuberculosis
- Idiopathic eosinophilic pneumonias
- Severe Allergic Reactions
- Severe Erythema multiforme
- Symptomatic Sarcoidosis
Research Report
A Comprehensive Monograph on Hydrocortisone Succinate (DB14545): From Molecular Structure to Clinical Application
Executive Summary
Hydrocortisone succinate is a synthetic, water-soluble hemisuccinate ester of hydrocortisone, the pharmaceutical name for the endogenous glucocorticoid cortisol.[1] It is classified as a short-acting corticosteroid that possesses both potent glucocorticoid (anti-inflammatory) and significant mineralocorticoid (salt-retaining) properties.[3] The primary clinical utility of hydrocortisone succinate stems from its formulation as a sterile powder for rapid parenteral (intravenous or intramuscular) administration. This characteristic makes it a cornerstone therapy for a multitude of acute, often life-threatening, conditions that demand immediate and powerful anti-inflammatory, immunosuppressive, or physiologic hormone replacement effects.[2]
The molecule functions as a prodrug; upon administration, it is rapidly hydrolyzed in the body to release its active moiety, hydrocortisone. The active hormone then binds to intracellular glucocorticoid receptors, and the resulting complex translocates to the cell nucleus to modulate the transcription of a wide array of genes. This genomic action ultimately leads to the suppression of key inflammatory pathways, including the inhibition of phospholipase A2 and pro-inflammatory transcription factors such as NF-kappa B.[8]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/02/08 | Phase 1 | Recruiting | |||
2023/03/09 | Phase 2 | Active, not recruiting | |||
2022/09/09 | Phase 2 | Recruiting | |||
2022/04/27 | Phase 4 | UNKNOWN | The London Clinic | ||
2022/04/11 | Phase 1 | Withdrawn | |||
2020/09/14 | Phase 2 | Recruiting | |||
2020/03/10 | Phase 3 | UNKNOWN | |||
2017/04/12 | Phase 4 | UNKNOWN | Xijing Hospital of Digestive Diseases | ||
2016/08/30 | Phase 3 | Active, not recruiting | |||
2016/07/11 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
HF Acquisition Co. LLC, DBA HealthFirst | 51662-1262 | INTRAMUSCULAR, INTRAVENOUS | 250 mg in 2 mL | 2/22/2024 | |
Cardinal Health 107, LLC | 55154-3942 | INTRAMUSCULAR, INTRAVENOUS | 100 mg in 2 mL | 10/17/2018 | |
HF Acquisition Co. LLC, DBA HealthFirst | 51662-1261 | INTRAMUSCULAR, INTRAVENOUS | 100 mg in 2 mL | 2/22/2024 | |
Pharmacia & Upjohn Company LLC | 0009-0013 | INTRAMUSCULAR, INTRAVENOUS | 250 mg in 2 mL | 1/4/2024 | |
Pharmacia & Upjohn Company LLC | 0009-0005 | INTRAMUSCULAR, INTRAVENOUS | 1000 mg in 8 mL | 1/4/2024 | |
Pharmacia & Upjohn Company LLC | 0009-0016 | INTRAMUSCULAR, INTRAVENOUS | 500 mg in 4 mL | 1/4/2024 | |
Pharmacia & Upjohn Company LLC | 0009-0825 | INTRAMUSCULAR, INTRAVENOUS | 100 mg in 2 mL | 1/4/2024 | |
Pharmacia & Upjohn Company LLC | 0009-0011 | INTRAMUSCULAR, INTRAVENOUS | 100 mg in 2 mL | 1/4/2024 |
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 |
---|---|---|---|---|---|
SOLU-CORTEF FOR INJECTION 100 mg/vial | SIN04791P | INJECTION, POWDER, FOR SOLUTION | 100 mg/vial | 6/26/1990 |
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
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 |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
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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