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therapeutic hydrocortisone
therapeutic hydrocortisone is a Corticosteroid Small molecule drug developed by AIDS Malignancy Consortium. It is currently in Phase 3 development for Severe asthma exacerbations, Severe allergic reactions (anaphylaxis), Severe skin conditions (e.g. psoriasis, eczema). Also known as: Aeroseb-HC, Barseb HC, Cetacort, Cort-Dome.
Therapeutic hydrocortisone is a corticosteroid that suppresses the immune system by inhibiting the production of inflammatory cytokines.
Therapeutic hydrocortisone is a glucocorticoid receptor agonist, classified as a small molecule drug. It has been studied in various clinical trials for conditions such as sepsis, acute respiratory failure, and kidney transplant recipient immunosuppression.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | therapeutic hydrocortisone |
|---|---|
| Also known as | Aeroseb-HC, Barseb HC, Cetacort, Cort-Dome, Cortef |
| Sponsor | AIDS Malignancy Consortium |
| Drug class | Corticosteroid |
| Target | Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Therapeutic hydrocortisone works by binding to the glucocorticoid receptor, which then translocates to the nucleus and regulates the expression of genes involved in inflammation. This leads to a decrease in the production of pro-inflammatory cytokines, such as IL-1 and TNF-alpha, and an increase in the production of anti-inflammatory cytokines, such as IL-10.
Approved indications
- Severe asthma exacerbations
- Severe allergic reactions (anaphylaxis)
- Severe skin conditions (e.g. psoriasis, eczema)
- Severe inflammatory conditions (e.g. rheumatoid arthritis, lupus)
Common side effects
- Adrenal insufficiency
- Glucose intolerance
- Hypokalemia
- Fluid retention
- Hypertension
- Osteoporosis
- Cushing's syndrome
- Growth suppression in children
- Psychiatric disturbances (e.g. anxiety, depression)
- Increased risk of infections
Key clinical trials
- Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (PHASE3)
- 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)
- A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia (PHASE3)
- Sleep Loss and Circadian Misalignment - Mechanisms of Insulin Resistance (PHASE4)
- A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab (PHASE3)
- IMPACT-MACS: Adrenalectomy vs Semaglutide for Metabolic Outcomes in Mild Autonomous Cortisol Secretion (NA)
- 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)
- Effects of Red and Infrared Photobiomodulation in Rhinoplasty at a Single Centre (NA)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- therapeutic hydrocortisone CI brief — competitive landscape report
- therapeutic hydrocortisone updates RSS · CI watch RSS
- AIDS Malignancy Consortium portfolio CI
Frequently asked questions about therapeutic hydrocortisone
What is therapeutic hydrocortisone?
How does therapeutic hydrocortisone work?
What is therapeutic hydrocortisone used for?
Who makes therapeutic hydrocortisone?
Is therapeutic hydrocortisone also known as anything else?
What drug class is therapeutic hydrocortisone in?
What development phase is therapeutic hydrocortisone in?
What are the side effects of therapeutic hydrocortisone?
What does therapeutic hydrocortisone target?
Related
- Drug class: All Corticosteroid drugs
- Target: All drugs targeting Glucocorticoid receptor
- Manufacturer: AIDS Malignancy Consortium — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Severe asthma exacerbations
- Indication: Drugs for Severe allergic reactions (anaphylaxis)
- Indication: Drugs for Severe skin conditions (e.g. psoriasis, eczema)
- Also known as: Aeroseb-HC, Barseb HC, Cetacort, Cort-Dome, Cortef
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing