Last reviewed · How we verify
Solu-Cortef (hydrocortisone succinate)
At a glance
| Generic name | hydrocortisone succinate |
|---|---|
| Sponsor | Pfizer |
| Drug class | Corticosteroid |
| Target | Glucocorticoid receptor |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1955 |
Approved indications
- Acquired thrombocytopenia
- Acute lymphoid leukemia
- Adrenal cortical hypofunction
- Adrenogenital disorder
- Allergic rhinitis
- Angioedema
- Ankylosing spondylitis
- Articular gout
- Aspiration pneumonitis
- Asthma
- Atopic dermatitis
- Autoimmune disease
- Autoimmune hemolytic anemia
- Berylliosis
- Bursitis
- Cerebral edema
- Congenital hypoplastic anemia
- Contact dermatitis
- Crohn's disease
- Dermatitis herpetiformis
Common side effects
- Infusion related reaction
- Flushing
- Intentional product use issue
- Toxicity to various agents
- Blood pressure fluctuation
- Urticaria
- Disseminated intravascular coagulation
- Drug interaction
- Nipple swelling
- Inappropriate schedule of product administration
- Pyrexia
- Cytomegalovirus viraemia
Key clinical trials
- A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia (PHASE3)
- A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab (PHASE3)
- Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (PHASE3)
- A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004) (PHASE3)
- A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL) (PHASE2)
- Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia (PHASE2)
- Sleep Loss and Circadian Misalignment - Mechanisms of Insulin Resistance (PHASE4)
- A Study to Find the Highest Dose of SNDX-5613 (Revumenib) as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, and Mixed Phenotype Acute Leukemia (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 12133914 | 2043-02-23 | Method of Use |
| 11904046 | 2043-02-23 | Formulation |
| 9717740 | 2032-11-19 | Method of Use |
| 9675559 | 2033-01-10 | Method of Use |
| 9649280 | 2034-05-12 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Solu-Cortef CI brief — competitive landscape report
- Solu-Cortef updates RSS · CI watch RSS
- Pfizer portfolio CI