Lorundrostat
MLS-101Direct competitor to baxdrostat. Launch-1 P3 (n=1,083) in HTN completed Q4 2025 with positive readout reported.
Emerging drug — Phase 3 readout — POSITIVE
✓ Won · Read out 2025-03-10Launch-HTN met primary endpoint: 16.9 mmHg systolic BP reduction at week 6 (placebo-adjusted 9.1 mmHg); 19.0 mmHg at week 12 (placebo-adjusted 11.7 mmHg). Advance-HTN also positive. Trial recognized in JAMA 'Research of the Year' 2025. NDA filing Q4 2025/Q1 2026.
Regulatory: NDA filed
→ Source PRNext remaining catalyst
AwaitingA positive readout makes CYP11B2 a validated target for the first time. Hover the badge above for what the confidence level means.
What does it do?
CYP11B2 — Aldosterone synthase
Modality: small-molecule selective aldosterone synthase inhibitor
Program: Launch-X
The 2 Phase 3 trials
| NCT ID | Indication | N | Status | Started | Primary completion | Readout |
|---|---|---|---|---|---|---|
| NCT05968430 | Hypertension | 1,076 | ACTIVE_NOT_RECRUITING | 2023-07-14 | 2025-12-30 (actual) | Awaiting |
| NCT06153693 | Hypertension | 1,083 | COMPLETED | 2023-11-22 | 2024-12-10 (actual) | Awaiting |
What's the case for and against?
✓ What's working in its favor
- Phase 2: -7.7 mmHg at 50mg vs placebo
- Launch-1 Phase 3 positive Q4 2025 (per company guidance)
- Positive P2 OSA + HTN exploratory trial
Who else is racing? — 2 other assets at CYP11B2
| Asset | Sponsor | Status |
|---|---|---|
| Baxdrostat | AstraZeneca | P3 BaxHTN — three completed trials reading out |
| Dexfadrostat | Damian Pharma | P2 primary aldosteronism |
Source: TheraRadar atomic trial table (built 2026-04-28 from ClinicalTrials.gov v2 API). Trial-target mapping validated via Gemini 2.0 + Gemini 3.1 Lite + Claude Haiku 4.5 multi-LLM consensus, with Claude Sonnet 4.6 arbitration. BD context curated by hand from public disclosures.