Mineralys Therapeutics

What Mineralys Therapeutics does

Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company incorporated in Delaware in May 2019 and headquartered in Radnor, Pennsylvania. The company is developing lorundrostat, a proprietary, orally administered, highly selective aldosterone synthase inhibitor that targets CYP11B2, the enzyme responsible for aldosterone production. Lorundrostat has demonstrated 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, a 10-12 hour half-life supporting once-daily dosing, and a 40-70% reduction in plasma aldosterone concentration in hypertensive participants. The asset was licensed from Tanabe Pharma Corporation in July 2020, with worldwide royalty obligations repurchased in June 2026, and has completed six late-stage clinical trials in hypertension, chronic kidney disease, and obstructive sleep apnea.

The company's commercial focus is uncontrolled and resistant hypertension, with approximately 20 million U.S. patients with systolic BP greater than 140 mmHg who have not achieved blood pressure goals despite treatment, representing a subset of the ~120 million U.S. patients with sustained elevated blood pressure and an estimated $219 billion annual economic burden. The Phase 3 Launch-HTN trial demonstrated 9.6-12.2 mmHg placebo-adjusted systolic blood pressure reductions and was recognized in JAMA's inaugural Research of the Year Roundup (2025). The FDA accepted the lorundrostat NDA in March 2026 with a PDUFA target action date of December 22, 2026.

Mineralys is pre-revenue and operates a U.S.-focused business model, with future revenue contingent on FDA approval and commercial launch via prescription drug sales through traditional pharmaceutical channels. The company is building pre-commercial infrastructure including Regional Sales Directors across 24 major U.S. metropolitan areas, Medical Science Liaisons in cardiovascular roles, market access planning, and payer engagement. Capitalization is substantial, with approximately $1.1 billion in aggregate gross proceeds raised since inception, $646.1 million in cash and investments as of March 31, 2026, and a $500 million committed debt facility from Pharmakon Advisors. The company trades on Nasdaq under ticker MLYS following its February 2023 IPO, with dispersed institutional ownership and Catalys Pacific as a significant legacy shareholder.

Name

Mineralys Therapeutics

Legal name

Mineralys Therapeutics, Inc.

Website

https://mineralystx.com

Company type

Public

Founded year

2019

Operating status

Operating

Headcount range

101–250 employees

Short description

Mineralys Therapeutics is a clinical-stage biopharmaceutical company developing lorundrostat, a proprietary highly selective aldosterone synthase inhibitor targeting uncontrolled and resistant hypertension, chronic kidney disease, and obstructive sleep apnea in U.S. patients, pending a December 22, 2026 FDA PDUFA date.

Ownership category

akta.pro rank

Headquarters

HQ city

Radnor

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Marketing or Sales, Operations

Revenue model

1. Pharmaceutical Product Sales: Mineralys is a pre-revenue clinical-stage biopharmaceutical company. If lorundrostat receives FDA approval, the company plans to commercialize the drug in the United States, generating revenue through prescription drug sales. The company is building commercial infrastructure including sales force, market access, and medical affairs teams in preparation for launch.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Mineralys Therapeutics is a clinical-stage biopharmaceutical company developing lorundrostat, a proprietary, orally administered, highly selective aldosterone synthase inhibitor (ASI). Lorundrostat is being developed for the treatment of uncontrolled and resistant hypertension, chronic kidney disease (CKD), and obstructive sleep apnea (OSA), with an FDA PDUFA target action date of December 22, 2026.

Product overview

Mineralys Therapeutics is a clinical-stage biopharmaceutical company with lorundrostat as its sole product candidate. Lorundrostat is a highly selective aldosterone synthase inhibitor (ASI) designed to reduce aldosterone levels by inhibiting CYP11B2. The company is preparing for potential FDA approval with a PDUFA date of December 22, 2026. The clinical program includes multiple trials: TARGET-HTN (Phase 2, completed), LAUNCH-HTN (Phase 3, pivotal), ADVANCE-HTN (Phase 2, pivotal), TRANSFORM-HTN (open-label extension, ongoing), EXPLORE-CKD (Phase 2, for CKD), and EXPLORE-OSA (Phase 2, for OSA).

Differentiator

Problem solved

Functional benefit

Products and services

• Lorundrostat Lorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor (ASI) designed to inhibit CYP11B2, the enzyme responsible for aldosterone production. It is being developed for adults with uncontrolled or resistant hypertension, chronic kidney disease (CKD), and obstructive sleep apnea (OSA), with 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro and once-daily dosing convenience.

Quantifiable outcome

• 9.6-12.2 mmHg systolic blood pressure reduction in Phase 3 Launch-HTN trial
• +6 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

One partnership is on record.

• Tanabe Pharma Corporation (formerly Mitsubishi Tanabe Pharma Corporation)coreOEM/ Whitelabel/ Licensing Partner · 31 July 2020In July 2020, Mineralys entered into an exclusive license agreement with Tanabe Pharma Corporation, gaining worldwide, royalty-bearing rights to develop and commercialize lorundrostat. The company paid a $1.0 million upfront fee and $9.0 million in development milestones. Remaining obligations include up to $155.0 million in commercial milestones plus tiered royalties ranging from mid-single digits to 10% of net sales. In June 2026, Mineralys amended the agreement to repurchase royalty obligations for $200 million upfront payment plus up to $365 million in potential milestone payments, acquiring full worldwide rights to lorundrostat.

Scale indicators8 records

Recent moves7 records

Expansion highlights5 records

Broad incumbents

• Novartis: Owns Entresto (sacubitril/valsartan) and a broad heart-failure / hypertension portfolio with established cardiovascular specialty field force and managed-care relationships.
• Eli Lilly: Large incumbent with deep cardiometabolic and obesity franchises (e.g., tirzepatide) that intersect hypertension and CKD; a potential strategic acquirer/partner and a benchmark for cardiovascular commercial scale.
• Bayer: Major cardiovascular incumbent with established hypertension (Kerendia/finerenone, an MRA in CKD) and cardio-renal-metabolic commercial infrastructure overlapping Mineralys's target physician base.
• Medtronic: Markets the Symplicity Spyral renal denervation system for hypertension and has the scale, clinical evidence base, and physician relationships to compete for the resistant hypertension patient population.

Emerging players

• Recor Medical: Develops the Paradise renal denervation system for resistant hypertension — a non-pharmacologic alternative competing for the same patient population Mineralys targets with lorundrostat.
• Idorsia Pharmaceuticals: Clinical-stage cardiovascular company developing aprocitentan (Tryvio), an endothelin receptor antagonist approved for resistant hypertension — a directly competing mechanism in the same patient population.
• Apnimed: Late-stage OSA-focused biopharma whose AD109 (pharmacologic OSA therapy) overlaps with Mineralys's Explore-OSA program and shares the same physician specialty audience.
• Madrigal Pharmaceuticals: Cardio-metabolic biopharma with Rezdiffra (resmetirom) for MASH — comparable sized mid-cap clinical-to-commercial biopharma with a cardio-renal-metabolic product profile and similar NASH/MASH prescriber overlaps.

Direct peers

• AstraZeneca (via CinCor Pharma / baxdrostat): AstraZeneca acquired CinCor Pharma in 2023 to advance baxdrostat, a direct aldosterone synthase inhibitor competing head-to-head with lorundrostat in resistant hypertension. Most directly comparable clinical-stage ASI competitor.
• CinCor Pharma: Pre-acquisition, CinCor was a clinical-stage biopharma developing baxdrostat, a direct aldosterone synthase inhibitor in the same indication as lorundrostat; the most direct pre-acquisition peer comparison for Mineralys.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xx.com/mineralystx
• LinkedInlinkedin.com/company/mineralys-therapeutics-inc

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds8 records

Investors19 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Mineralys Therapeutics