Last reviewed · How we verify
Stage 3: glucocorticoid
Stage 3: glucocorticoid is a Small molecule drug developed by Cougar Biotechnology, Inc.. It is currently in Phase 1 development.
Stage 3 of glucocorticoid treatment involves the use of small molecule glucocorticoids, such as 3', 3',5'-Trimethoxychalcone, which is being studied in various clinical trials for conditions including Diabetic Macular Edema, Prostate Neoplasms, Duchenne Muscular Dystrophy, Leukemia, Mast-Cell, and Mantle-cell Lymphoma. These small molecule glucocorticoids are being investigated in trials using different interventions, including OXU-001 and Ozurdex Ophthalmic Intravitreal Implant.
-
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 | Stage 3: glucocorticoid |
|---|---|
| Sponsor | Cougar Biotechnology, Inc. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus (PHASE3)
- A 52-week Study of Rilzabrutinib Efficacy and Safety Compared to Placebo in Adults Diagnosed With IgG4-related Disease (PHASE3)
- A Study of Enzalutamide Plus the Glucocorticoid Receptor Antagonist Relacorilant Versus Placebo for Patients With High-risk Localized Prostate Cancer (PHASE2)
- A Study With Imlifidase in Anti-GBM Disease (PHASE3)
- Acute Consequences of Glucocorticoid Secretion in Overweight and Obese Individuals During Maximum Calorie Intake (NA)
- A Trial to Learn More About an Experimental Gene Therapy Called Bidridistrogene Xeboparvovec (SRP-9003) as a Possible Treatment for Limb Girdle Muscular Dystrophy 2E/R4 (PHASE3)
- A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis (PHASE2)
- Tocilizumab Discontinuation Versus Dose Reduction for Patients With Well-Controlled Giant Cell Arteritis (PHASE2)
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:
- Stage 3: glucocorticoid CI brief — competitive landscape report
- Stage 3: glucocorticoid updates RSS · CI watch RSS
- Cougar Biotechnology, Inc. portfolio CI
Frequently asked questions about Stage 3: glucocorticoid
What is Stage 3: glucocorticoid?
Who makes Stage 3: glucocorticoid?
What development phase is Stage 3: glucocorticoid in?
Related
- Manufacturer: Cougar Biotechnology, Inc. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing