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Miricorilant 100 mg
Miricorilant 100 mg is a Small molecule drug developed by Corcept Therapeutics. It is currently in Phase 1 development. Also known as: CORT118335.
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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 | Miricorilant 100 mg |
|---|---|
| Also known as | CORT118335 |
| Sponsor | Corcept Therapeutics |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Diarrhoea
- Alanine aminotransferase increased
- Nausea
- Aspartate aminotransferase increased
- Akathisia
- Orthostatic hypotension
- Anaemia
- Somnolence
Key clinical trials
- Evaluation of Miricorilant on Liver Fat in Patients With MASLD (PHASE1)
- A Phase 2b, Study Evaluating Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH) (PHASE2)
- Study Evaluating the Bioavailability of Miricorilant With Optional Food Effect Assessment in Healthy Adult Subjects (PHASE1)
- A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adults With Schizophrenia or Bipolar Disorder Treated With Antipsychotic Medications (PHASE2)
- A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH) (PHASE1)
- Study to Evaluate the Effects of a Cytochrome P450 2C19 Inhibitor on the Pharmacokinetics of Miricorilant (PHASE1)
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:
- Miricorilant 100 mg CI brief — competitive landscape report
- Miricorilant 100 mg updates RSS · CI watch RSS
- Corcept Therapeutics portfolio CI
Frequently asked questions about Miricorilant 100 mg
What is Miricorilant 100 mg?
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Is Miricorilant 100 mg also known as anything else?
What development phase is Miricorilant 100 mg in?
What are the side effects of Miricorilant 100 mg?
Related
- Manufacturer: Corcept Therapeutics — full pipeline
- Also known as: CORT118335
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing