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Hydrocortisone Low Dose
Hydrocortisone Low Dose is a Small molecule drug developed by Cedars-Sinai Medical Center. It is currently in Phase 1 development. Also known as: Solumedrol, Corticosteroid, Steroid.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Hydrocortisone Low Dose |
|---|---|
| Also known as | Solumedrol, Corticosteroid, Steroid |
| Sponsor | Cedars-Sinai Medical Center |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency (PHASE4)
- Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation (EARLY_PHASE1)
- A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations (PHASE3)
- Platform of Randomized Adaptive Clinical Trials in Critical Illness (NA)
- Study on the Mechanism of Pei Tu Ning Feng Tang in Alleviating Tourette Syndrome Via Functional Near-Infrared Spectroscopy (fNIRS) and the DA-MAPK-BDNF Pathway (NA)
- Subjective Experience Following Psilocybin (PHASE2)
- Assessing the Impact of High Theacrine Doses on Hemodynamic Measures (NA)
- Maximising Time With a Normal Blood Glucose to Restore the Glucagon Response in Type 1 Diabetes (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:
- Hydrocortisone Low Dose CI brief — competitive landscape report
- Hydrocortisone Low Dose updates RSS · CI watch RSS
- Cedars-Sinai Medical Center portfolio CI
Frequently asked questions about Hydrocortisone Low Dose
What is Hydrocortisone Low Dose?
Who makes Hydrocortisone Low Dose?
Is Hydrocortisone Low Dose also known as anything else?
What development phase is Hydrocortisone Low Dose in?
Related
- Manufacturer: Cedars-Sinai Medical Center — full pipeline
- Also known as: Solumedrol, Corticosteroid, Steroid
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing