SOLU-CORTEF (hydrocortisone sodium succinate) · PHARMACIA AND UPJOHN
When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-CORTEF Sterile Powder is indicated as follows: Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transf...
Development Insights
Details
- Status
- Prescription
- First Approved
- 1955-04-27
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
SOLU-CORTEF Approval History
What SOLU-CORTEF Treats
44 indicationsSOLU-CORTEF is approved for 44 conditions since its original approval in 1955. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Asthma
- Atopic Dermatitis
- Contact Dermatitis
- Drug Hypersensitivity
- Serum Sickness
- Transfusion Reactions
- Bullous Dermatitis Herpetiformis
- Exfoliative Erythroderma
- Mycosis Fungoides
- Pemphigus
- Stevens-Johnson Syndrome
- Adrenocortical Insufficiency
- Congenital Adrenal Hyperplasia
- Nonsuppurative Thyroiditis
- Regional Enteritis
- Ulcerative Colitis
- Autoimmune Hemolytic Anemia
- Diamond-Blackfan Anemia
- Idiopathic Thrombocytopenic Purpura
- Pure Red Cell Aplasia
- Thrombocytopenia
- Trichinosis
- Tuberculous Meningitis
- Leukemia
- Lymphoma
- Cerebral Edema
- Sympathetic Ophthalmia
- Uveitis
- Ocular Inflammation
- Nephrotic Syndrome
- Berylliosis
- Pulmonary Tuberculosis
- Eosinophilic Pneumonia
- Sarcoidosis
- Gouty Arthritis
- Rheumatic Carditis
- Ankylosing Spondylitis
- Psoriatic Arthritis
- Rheumatoid Arthritis
- Juvenile Rheumatoid Arthritis
- Dermatomyositis
- Temporal Arteritis
- Polymyositis
- Systemic Lupus Erythematosus
SOLU-CORTEF Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in SOLU-CORTEF's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications SOLU-CORTEF treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to SOLU-CORTEF
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02112916 results posted | NCI-2014-00712 NCI-2014-00712, s14-01925 | Ph 3 | active not recruiting | Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma |
| NCT02883049 results posted | NCI-2011-03797 NCI-2011-03797, S12-01254 | Ph 3 | completed | Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations |
| NCT05761171 | AALL2121 NCI-2023-00503, AALL2121 | Ph 2 | active not recruiting | A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia |
| NCT06247787 | PEPN2312 NCI-2023-11026, PEPN2312 | Ph 1 | recruiting | A Study to Find the Highest Dose of Imetelstat in Combination With Fludarabine and Cytarabine for Patients With AML, MDS or JMML That Has Come Back or Does Not Respond to Therapy |
| NCT04546399 | NCI-2020-06813 NCI-2020-06813, AALL1821 | Ph 2 | recruiting | A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL) |
| NCT02828358 results posted | NCI-2016-00973 NCI-2016-00973, s17-00488 | Ph 2 | completed | Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement |
| NCT02096510 | 2013/1738 | Ph 1, Ph 2 | completed | Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal Hyperplasia |
| NCT05320380 | APAL2020B NCI-2022-02157, APAL2020B | Ph 1, Ph 2 | withdrawn | A Study of the Drug IMGN632 in Children With Leukemia That Has Come Back After Treatment or is Difficult to Treat |
| NCT00720109 results posted | NCI-2009-00312 NCI-2009-00312, AALL0622 | Ph 2, Ph 3 | completed | Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SOLU-CORTEF FDA Label Details
Indications & Usage
FDA Label (PDF)When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-CORTEF Sterile Powder is indicated as follows: Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment