What Crystalys Therapeutics does

Crystalys Therapeutics is a clinical-stage biopharmaceutical company headquartered in San Diego, California, developing dotinurad, a next-generation, once-daily, oral, highly selective urate transporter 1 (URAT1) inhibitor for the treatment of gout. The company targets the treatment gap between first-line xanthine oxidase inhibitors such as allopurinol and last-line intravenous uricase, addressing patients who do not achieve adequate uric acid control on existing therapies. Dotinurad has been approved in five Asian jurisdictions (Japan, China, Philippines, Taiwan, Thailand) and has been administered to more than 2.2 million patients since its 2020 Japan launch, supported by 22 completed clinical studies and over 1,300 trial participants.

The company was co-founded in September 2025 by its Executive Team, Catalys Pacific, and Novo Holdings, and closed a $205 million Series A financing at launch to fund global development. Crystalys is currently running two pivotal Phase 3 trials — RUBY (hyperuricemia-associated gout) and TOPAZ (tophaceous gout) — both with allopurinol comparators, and a Phase 2 trial (AMETHYST) in XOI-intolerant or uricase-failure patients. The RUBY study was expanded to European sites in February 2026 to support a planned MAA alongside the U.S. NDA pathway. The company has assembled a board and management team with deep gout franchise and commercialization experience, including prior operators from Ardea Biosciences (acquired by AstraZeneca) and the former CEO of Horizon Therapeutics (acquired by Amgen for $28.3 billion).

Crystalys is pre-revenue and currently monetizes nothing; its business model is to commercialize dotinurad as a prescription pharmaceutical in North America and Europe following regulatory approval, distributing through standard pharmaceutical wholesale and pharmacy channels. As of the latest disclosed date, the company has 11–50 employees and no disclosed pricing or launch revenue. Its go-to-market is enterprise field-sales style targeting rheumatologists and other gout prescribers, supplemented by conference participation and investor relations activity ahead of commercial readiness.

Name

Crystalys Therapeutics

Legal name

Crystalys Therapeutics Inc.

Website

https://crystalystx.com

Company type

Private

Founded year

2025

Operating status

Operating

Headcount range

11–50 employees

Short description

Crystalys Therapeutics is a clinical-stage biopharmaceutical company developing dotinurad, a once-daily oral URAT1 inhibitor, as a second-line therapy for gout patients who fail first-line xanthine oxidase inhibitors, targeting regulatory approval in the U.S. and Europe.

Ownership category

akta.pro rank

Product category

Gout Therapeutics

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Therapeutic Radiopharmaceuticals (Radioligand/Targeted Radionuclide Therapy) (HLAIAGAB)

akta.pro secondary industry

Lead Optimization & Preclinical Candidate Selection (HLAIALAB)

Keywords

• Gout therapeutics
• URAT1 inhibitor
• Biopharmaceutical development
• Hyperuricemia treatment
• Clinical-stage drug

Headquarters

HQ city

San Diego

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Pharmaceutical Product Sales: Crystalys is a clinical-stage biopharmaceutical company preparing for commercialization of dotinurad as a prescription medication for gout. The company plans to generate revenue through sales of its FDA/EMA-approved drug following successful completion of Phase 3 trials and regulatory approval in the U.S. and Europe.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels4 records

Core offering

Crystalys Therapeutics is developing dotinurad, a once-daily, oral, highly selective URAT1 inhibitor for the treatment of gout and hyperuricemia. The drug is being advanced through Phase 2 and Phase 3 clinical trials in the U.S. and Europe, targeting patients who have failed first-line xanthine oxidase inhibitors such as allopurinol. Dotinurad is already approved and commercially used in Japan, China, the Philippines, Taiwan, and Thailand.

Product overview

Crystalys Therapeutics is a clinical-stage biopharmaceutical company developing dotinurad, a next-generation URAT1 inhibitor, as a treatment for gout. The company was co-founded by the Executive Team, Catalys Pacific, and Novo Holdings, and is advancing dotinurad through Phase 2 and Phase 3 clinical trials (AMETHYST, RUBY, and TOPAZ studies) for regulatory approval and commercial launch in North America and Europe. The drug is already approved and actively treating patients in Japan, China, the Philippines, Taiwan, and Thailand.

Differentiator

Problem solved

Functional benefit

Products and services

• Dotinurad Dotinurad is a novel, once-daily, oral, highly selective urate transporter 1 (URAT1) inhibitor designed to increase uric acid excretion by the kidney by targeting renal transport pathways responsible for urate reabsorption. It is being developed for patients with gout and hyperuricemia who have failed or are intolerant to first-line urate-lowering therapies such as allopurinol, addressing the treatment gap between first-line xanthine oxidase inhibitors and last-line intravenous uricase. It is approved in Japan, China, the Philippines, Taiwan, and Thailand, and is currently in Phase 2 and Phase 3 clinical trials (AMETHYST, RUBY, TOPAZ) in the U.S. and Europe.

Quantifiable outcome

• 2.2 million patients treated since 2020 launch in Japan
• +2 more outcomes

Named customers1 record

Segments1 record

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Scale indicators5 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Selecta Biosciences: Developed SEL-212 (pegsiticase), a novel pegylated uricase therapy for treatment-refractory gout, positioning in the same refractory gout segment as Crystalys' AMETHYST trial. Represents a competitive threat in the later-line gout space.
• Horizon Therapeutics: Built a multi-billion-dollar gout franchise around Krystexxa (pegloticase), an intravenous uricase for refractory chronic gout. Acquired by Amgen for $28.3 billion in 2023. Horizon's commercial playbook under former CEO Tim Walbert (now on Crystalys' board) represents the strategic template Crystalys is following.
• Fortress Biotech / Urica Therapeutics: Fortress subsidiary Urica Therapeutics is jointly developing gout therapies with Crystalys, including co-announcement of Phase 3 trials dosing. Direct commercial-stage partner and clinical collaborator in the gout space.
• Ardea Biosciences: Developed lesinurad (Zurampic), the first URAT1 inhibitor approved in the U.S., and Duzallo. Acquired by AstraZeneca in 2012. Crystalys' CEO James Mackay was President and CEO of Ardea, and CMO Nihar Bhakta led the gout franchise clinical program there — making Ardea the closest direct precedent for dotinurad's regulatory and commercial path.

Emerging players

• Aristea Therapeutics: Clinical-stage immunology company co-founded by several of Crystalys' leaders (CEO James Mackay, CFO Justin Thacker, ED DeAnne Reid). Sister company from the same founding team, providing insights into the team's operating model but focused on different therapeutic areas.

Others

• Mineralys Therapeutics: Clinical-stage biopharma also founded by Catalys Pacific (Crystalys' co-founder), focused on cardiorenal diseases. Sister portfolio company demonstrating Catalys Pacific's company-creation model but not directly competing in gout.
• Sarepta Therapeutics: Led by Chris Garabedian (2011-2015), now a Crystalys board director representing Perceptive/Xontogeny. While focused on Duchenne muscular dystrophy rather than gout, Sarepta represents the high-value rare/specialty disease commercialization playbook that Crystalys' board member helped architect.

Broad incumbents

• AstraZeneca: Acquired Ardea Biosciences in 2012 and held the original lesinurad franchise globally before its U.S. withdrawal in 2019. As the historical steward of URAT1 inhibitor commercialization, AstraZeneca represents both a potential competitor and a likely strategic acquirer for Crystalys.
• Takeda Pharmaceutical: Acquired IDM Pharma (where Tim Walbert served as CEO) and has a global specialty pharma franchise with existing gout and inflammation commercial infrastructure in major markets. Represents a plausible strategic acquirer for Crystalys post-Phase 3 success.
• BioCryst Pharmaceuticals: Commercial-stage rare disease company with complementary urate-lowering programs and broader specialty pharma capabilities. Represents a potential strategic acquirer or commercial partner for Crystalys given its established sales infrastructure in adjacent therapeutic areas.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/Crystalys_Tx
• LinkedInlinkedin.com/company/crystalys-therapeutics

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 records

Funding overview

Funding rounds2 records

Investors21 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 Crystalys Therapeutics