ALS Tracker

← All drugs

In development

Fasudil (oral)

Also known as BRAVYL, WP-0512

Bottom line

A placebo-controlled trial of fasudil by drip found no effect on function or survival. The pill lowered a nerve-damage marker at one dose in a study with no placebo group. Whether it slows ALS is unknown.

Fasudil is a drug used in Japan for decades after a type of brain bleed. Woolsey Pharmaceuticals is testing a pill version called BRAVYL for ALS. An open-label study of 62 people, published in June 2026, found it was safe, and the lower dose lowered a blood marker of nerve damage, but with no placebo group it cannot show whether the drug slows ALS. An earlier placebo-controlled trial of fasudil given by drip found no effect on function or survival. No placebo-controlled trial of the pill has been announced yet.

Information checked 5 Nov 2026

Evidence: Hints only

Studies: 3 mixed

Controlled trials missed their main goal. Some measures or subgroups looked better, which needs confirming.

Not shown to slow ALS; marker fell 15% at 180 mg

Blood NfL 15.4% lower after 24 weeks at 180 mg (no change at 300 mg); no placebo group

How we decide the overall verdict: How to read this site.

At a glance

CompanyWoolsey PharmaceuticalsExplanation and sources

Woolsey is a small private company in New York. It raised extra Series B funding in February 2025 to advance its ALS programme. Its website's newsroom has not posted anything since that announcement, and the study results came out as a journal article in June 2026 rather than a company press release.

Sources

  1. Woolsey Pharmaceuticals Completes B Round Extension to Advance Its ALS ProgramWoolsey Pharmaceuticals · 27 Feb 2025 · Company press release
  2. Woolsey Pharmaceuticals newsWoolsey Pharmaceuticals · Company website
  3. An open-label Phase 2a study of fasudil in amyotrophic lateral sclerosis: safety and exploratory endpointsAmyotrophic Lateral Sclerosis and Frontotemporal Degeneration · 29 Jun 2026 · Peer-reviewed paper
How it worksBlocks an enzyme (ROCK) that damages nerve connectionsRho kinase (ROCK)Explanation and sources

Fasudil blocks Rho kinase (ROCK), an enzyme that becomes overactive in ALS and is thought to damage the connections between nerves and muscles, increase inflammation and stop nerve fibres regrowing. In the oral study, a marker of ROCK being blocked (pAKT) rose in tiny particles from nerve cells in the blood and spinal fluid, suggesting the drug reaches its target.

Sources

  1. Woolsey Pharmaceuticals pipelineWoolsey Pharmaceuticals · Company website
  2. An open-label Phase 2a study of fasudil in amyotrophic lateral sclerosis: safety and exploratory endpointsAmyotrophic Lateral Sclerosis and Frontotemporal Degeneration · 29 Jun 2026 · Peer-reviewed paper
StagePhase 2Open-label Phase 2a done; placebo-controlled trial not yet announcedExplanation and sources

The REAL study tested two doses (180 mg and 300 mg a day) in two groups of 31 people for 24 weeks in the US and Australia. Results were published in June 2026. The registry still lists the study as active, not recruiting, with long-term follow-up to 2029. The authors say the 180 mg dose should now be tested against placebo, but as of October 2026 no such trial was registered.

Sources

  1. Oral fasudil in ALS, REAL study (NCT05218668)ClinicalTrials.gov · Trial registry
  2. An open-label Phase 2a study of fasudil in amyotrophic lateral sclerosis: safety and exploratory endpointsAmyotrophic Lateral Sclerosis and Frontotemporal Degeneration · 29 Jun 2026 · Peer-reviewed paper
  3. Does fasudil taken by mouth for months slow ALS/MND compared with a placebo?Compass · Patient organisation
Best reported effectNot shown to slow ALS; marker fell 15% at 180 mgBlood NfL 15.4% lower after 24 weeks at 180 mg (no change at 300 mg); no placebo groupExplanation and sources

In the 180 mg group, blood neurofilament light (NfL, a marker of nerve damage that normally creeps up) fell by 15.4% over 24 weeks; at 300 mg it did not change. Function, breathing and muscle strength results were not statistically significant. Everyone got the drug, so the study cannot show it slows ALS; a company comparison with patients from an older trial also found no significant difference in function. An earlier placebo-controlled trial of fasudil given into a vein for 20 days (ROCK-ALS, 118 people) found it safe but showed no effect on function or survival.

This is the most favourable result reported. See all key studies for the full picture.

Sources

  1. An open-label Phase 2a study of fasudil in amyotrophic lateral sclerosis: safety and exploratory endpointsAmyotrophic Lateral Sclerosis and Frontotemporal Degeneration · 29 Jun 2026 · Peer-reviewed paper
  2. ROCK-ALS trial of intravenous fasudil in ALSThe Lancet Neurology · Peer-reviewed paper
  3. Does fasudil taken by mouth for months slow ALS/MND compared with a placebo?Compass · Patient organisation
  4. Results of Woolsey Pharmaceuticals' Phase 2a Study of BRAVYL in ALS Patients Shows Statistically Significant Reduction in Neurofilament Light and Directionally Improved Clinical OutcomesWoolsey Pharmaceuticals · 19 Jun 2024 · Company press release
Who it's forAdults with ALS (study sites in the US and Australia)All ALS · Pill, dailyExplanation and sources

The oral study enrolled adults with ALS at sites in the United States and Australia. More people stopped early at the higher dose (71% finished) than the lower dose (81%). Side effects were mostly mild.

Sources

  1. Oral fasudil in ALS, REAL study (NCT05218668)ClinicalTrials.gov · Trial registry
  2. An open-label Phase 2a study of fasudil in amyotrophic lateral sclerosis: safety and exploratory endpointsAmyotrophic Lateral Sclerosis and Frontotemporal Degeneration · 29 Jun 2026 · Peer-reviewed paper
What's nextPlacebo-controlled trial of 180 mg oral fasudil (not yet announced)Explanation and sources

The published study recommends a double-blind, placebo-controlled trial of the 180 mg dose. Woolsey has not announced plans, timing or funding for it, and an October 2026 registry search by the Compass project found no such trial.

Sources

  1. An open-label Phase 2a study of fasudil in amyotrophic lateral sclerosis: safety and exploratory endpointsAmyotrophic Lateral Sclerosis and Frontotemporal Degeneration · 29 Jun 2026 · Peer-reviewed paper
  2. Does fasudil taken by mouth for months slow ALS/MND compared with a placebo?Compass · Patient organisation
Can I join?No trial recruitingExplanation and sources

The oral fasudil study is no longer enrolling and no expanded access programme has been announced. Fasudil is not approved in the US or Europe.

Sources

  1. Oral fasudil in ALS, REAL study (NCT05218668)ClinicalTrials.gov · Trial registry
  2. Does fasudil taken by mouth for months slow ALS/MND compared with a placebo?Compass · Patient organisation

Signal: Silent

Signal measures how often, and how reliably, Woolsey Pharmaceuticals tells the public about this drug. It says nothing about whether the drug works. A quiet company isn't necessarily a bad sign, but regular, on-time updates help patients plan.

Last company update27 Feb 2025 (20 months ago)0 / 40
Company updates in the last 12 months00 / 35
Promises kept0 of 1 on time13 / 25
Signal score13 / 100 · Silent

Announced milestones

70 or more is Active, 45 or more is Steady, 20 or more is Quiet, below 20 is Silent. Full method.

Timeline

7 events, newest first. Company updates are marked; independent news and regulator decisions are shown too.

2026

  1. NewsCompass

    No placebo-controlled oral fasudil trial found in registries

    The Compass project's registry search found no placebo-controlled trial of oral fasudil in ALS.

  2. PublicationAmyotrophic Lateral Sclerosis and Frontotemporal Degeneration

    Open-label Phase 2a results published

    Oral fasudil was safe; blood NfL fell 15.4% at 180 mg but not at 300 mg, and functional results were not significant. The authors recommend a placebo-controlled trial of 180 mg.

2025

  1. Press releaseFrom the companyWoolsey Pharmaceuticals

    Woolsey extends Series B funding for ALS

    The company closed extra funding to advance BRAVYL and repeated that it expected a readout in June 2025. This is the last news item on its website.

2024

  1. Press releaseFrom the companyWoolsey Pharmaceuticals

    Company reports less TDP-43 spread in treated patients

    Woolsey said lab tests of tiny particles in patients' blood suggested less spread of the toxic protein TDP-43 during treatment, and expected full results in June 2025.

  2. Press releaseFrom the companyWoolsey Pharmaceuticals

    High-dose (300 mg) group fully enrolled

    Woolsey said it had finished recruiting the 300 mg group and expected results by mid-2025.

  3. Press releaseFrom the companyWoolsey Pharmaceuticals

    Company reports 180 mg REAL results

    Woolsey said blood NfL fell 15% at 180 mg; compared with matched patients from an older trial, function declined 28% more slowly, a difference that was not statistically significant.

  4. ConferenceFrom the companyWoolsey Pharmaceuticals

    Interim oral fasudil data shown at ENCALS

    Woolsey presented a poster on its open-label REAL study of oral fasudil at the European ALS meeting.

All sources for this page

  1. Woolsey Pharmaceuticals newsWoolsey Pharmaceuticals · Company website
  2. Woolsey Pharmaceuticals pipelineWoolsey Pharmaceuticals · Company website
  3. Results of Woolsey Pharmaceuticals' Phase 2a Study of BRAVYL in ALS Patients Shows Statistically Significant Reduction in Neurofilament Light and Directionally Improved Clinical OutcomesWoolsey Pharmaceuticals · 19 Jun 2024 · Company press release
  4. Woolsey Pharmaceuticals Completes Patient Recruitment for High-Dose Cohort of ALS StudyWoolsey Pharmaceuticals · 12 Nov 2024 · Company press release
  5. Woolsey Pharmaceuticals Reveals Findings Showing Spread of Toxic TDP-43 Pathology Reduced in BRAVYL-Treated ALS PatientsWoolsey Pharmaceuticals (PR Newswire) · 9 Dec 2024 · Company press release
  6. Woolsey Pharmaceuticals Completes B Round Extension to Advance Its ALS ProgramWoolsey Pharmaceuticals · 27 Feb 2025 · Company press release
  7. An open-label Phase 2a study of fasudil in amyotrophic lateral sclerosis: safety and exploratory endpointsAmyotrophic Lateral Sclerosis and Frontotemporal Degeneration · 29 Jun 2026 · Peer-reviewed paper
  8. Oral fasudil in ALS, REAL study (NCT05218668)ClinicalTrials.gov · Trial registry
  9. ROCK-ALS trial of intravenous fasudil in ALSThe Lancet Neurology · Peer-reviewed paper
  10. Does fasudil taken by mouth for months slow ALS/MND compared with a placebo?Compass · Patient organisation