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lorundrostat Dose 1
lorundrostat Dose 1 is a 11β-HSD1 inhibitor Small molecule drug developed by Mineralys Therapeutics Inc.. It is currently in Phase 3 development for Congestive heart failure.
Lorundrostat is a selective, reversible inhibitor of 11β-HSD1.
Lorundrostat Dose 1 is being studied in a clinical trial for its efficacy and safety in treating uncontrolled and resistant hypertension. The study, identified as NCT06153693, is a randomized, double-blind, placebo-controlled trial comparing lorundrostat Dose 1 to a placebo.
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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).
| 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 | lorundrostat Dose 1 |
|---|---|
| Sponsor | Mineralys Therapeutics Inc. |
| Drug class | 11β-HSD1 inhibitor |
| Target | 11β-HSD1 |
| Modality | Small molecule |
| Therapeutic area | Metabolic disorders |
| Phase | Phase 3 |
Mechanism of action
By inhibiting 11β-HSD1, lorundrostat reduces cortisol production in the body, which can help alleviate symptoms of certain conditions.
Approved indications
- Congestive heart failure
Common side effects
- Nausea
- Diarrhea
- Fatigue
Key clinical trials
- A Pivotal Study to Evaluate the Efficacy of Lorundrostat in Subjects With Uncontrolled Hypertension on a Standardized Antihypertensive Medication Regimen (PHASE2)
- Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension (PHASE3)
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:
- lorundrostat Dose 1 CI brief — competitive landscape report
- lorundrostat Dose 1 updates RSS · CI watch RSS
- Mineralys Therapeutics Inc. portfolio CI
Frequently asked questions about lorundrostat Dose 1
What is lorundrostat Dose 1?
How does lorundrostat Dose 1 work?
What is lorundrostat Dose 1 used for?
Who makes lorundrostat Dose 1?
What drug class is lorundrostat Dose 1 in?
What development phase is lorundrostat Dose 1 in?
What are the side effects of lorundrostat Dose 1?
What does lorundrostat Dose 1 target?
Related
- Drug class: All 11β-HSD1 inhibitor drugs
- Target: All drugs targeting 11β-HSD1
- Manufacturer: Mineralys Therapeutics Inc. — full pipeline
- Therapeutic area: All drugs in Metabolic disorders
- Indication: Drugs for Congestive heart failure
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing