In development

NB-4746

Bottom line

Very early. Safe in healthy volunteers by the company's account, and now in its first small trial in people with ALS, mainly for safety. No ALS results yet, and blocking SARM1 did not help in a common ALS mouse model.

NB-4746 is an experimental capsule taken twice a day that blocks SARM1, a protein that makes damaged nerve fibres self-destruct. After a safety study in healthy volunteers, it is now in its first trial in people with ALS: about 80 people in Australia, Canada, the Netherlands and Poland. The trial mainly checks safety and also looks at a blood marker of nerve damage. There are no results in ALS yet.

Information checked 5 Nov 2026

Evidence: Results pending

Studies: 2 running

Trials are running, but there are no efficacy results yet.

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

At a glance

CompanyNura BioExplanation and sources

Nura Bio is a private biotech in South San Francisco and NB-4746 is its lead drug. It raised more than $140 million in its first funding rounds and a further $73.8 million in June 2026, led by The Column Group with Euclidean Capital, Samsara BioCapital and Sanofi Ventures. It is also testing a second SARM1 blocker, NB-9402, in healthy volunteers.

How it worksBlocks a protein that makes damaged nerve fibres break downSARM1 inhibitor (reversible, oral, brain-penetrant)Explanation and sources

SARM1 is an enzyme inside nerve cells that, once switched on by injury or stress, burns up the cell's energy molecule NAD and makes the long nerve fibre (axon) fall apart. Blocking it protects nerve fibres in lab and animal studies, and rare overactive versions of the SARM1 gene are found more often in people with ALS. But removing SARM1 entirely did not slow disease in the most widely used ALS mouse model (SOD1), so it is unclear how much this pathway drives ALS. Eli Lilly is also starting trials of its own SARM1 blocker in ALS.

StagePhase 1/2Phase 1b/2a in people with ALS recruiting, ~80 peopleExplanation and sources

The current trial (NCT07369076) doses people with ALS, not healthy volunteers. Part A compares two doses with placebo for 28 days; Part B compares the chosen dose with placebo for 12 weeks and looks at whether it lowers neurofilament light (NfL), a blood marker of nerve damage. That is why it counts as Phase 1/2, but its main goal in both parts is safety, so it is not designed to show whether the drug slows ALS. The registry lists a start date of 4 March 2026; Nura Bio said dosing had begun by June 2026. Before this, two Phase 1 studies in healthy volunteers were completed in Australia.

Best reported effectNo ALS results yetSafety; NfL blood marker over 12 weeks (Part B)Explanation and sources

No results in people with ALS have been reported. In healthy volunteers, Nura Bio says NB-4746 was well tolerated, had no serious side effects and reached the levels it was aiming for in blood and spinal fluid; these results are from press releases and have not been published in full. The company says it protected nerves in animal models, including ALS, but most drugs that work in mice do not work in people.

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

Who it's forAdults 18-80 with ALS; symptoms began within 4 years (Part A) or 2 (Part B)All ALS · Capsules by mouth, twice dailyExplanation and sources

The trial is for adults aged 18 to 80 with ALS who can still eat by mouth and have breathing capacity of at least 60% of normal. Symptoms must have started within 48 months for Part A and within 24 months for Part B. People on stable riluzole or edaravone can join; people taking or planning tofersen cannot.

Sources

  1. A Phase 1b/2 Study to Evaluate NB-4746 in Participants With ALS (NCT07369076)ClinicalTrials.gov · 17 Sept 2026 · Trial registry
What's nextMain part of the ALS trial due to finish (registry estimate)Expected April 2027Explanation and sources

ClinicalTrials.gov estimates the main part of the trial will finish in April 2027 and the whole study, including the extension, in February 2028. Nura Bio has not publicly said when it will share results.

Sources

  1. A Phase 1b/2 Study to Evaluate NB-4746 in Participants With ALS (NCT07369076)ClinicalTrials.gov · 17 Sept 2026 · Trial registry
Can I join?Recruiting in Australia, Canada, the Netherlands and PolandRecruiting nowExplanation and sources

The ALS trial is recruiting at 12 sites: six in Australia, three in Canada (Fredericton, Toronto, Montreal), Utrecht in the Netherlands, and Krakow and Warsaw in Poland. There are no US sites listed. For 28 days, people have a 1 in 3 chance of placebo; for the 12-week part, a 1 in 2 chance. Everyone who finishes can choose to take NB-4746 in an extension. There is no expanded access programme.

Sources

  1. A Phase 1b/2 Study to Evaluate NB-4746 in Participants With ALS (NCT07369076)ClinicalTrials.gov · 17 Sept 2026 · Trial registry
  2. Clinical Research & Trials Update, August 2026ALS Society of Canada · 1 Sept 2026 · Patient organisation

Signal: Quiet

Signal measures how often, and how reliably, Nura Bio 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 update22 Jun 2026 (4 months ago)12 / 40
Company updates in the last 12 months16 / 35
Promises kept0 of 2 on time13 / 25
Signal score31 / 100 · Quiet

Announced milestones

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

Timeline

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

2026

  1. NewsALS Society of Canada

    ALS Canada lists the trial as recruiting in Canada

    ALS Canada's trial update listed the NB-4746 trial as a new study recruiting in Fredericton and Montreal.

  2. Press releaseFrom the companyNura Bio

    First person with ALS dosed; $73.8 million raised

    Nura Bio said dosing had begun in its ALS trial and that new funding would pay for it, plus a healthy-volunteer study of a second SARM1 blocker, NB-9402.

  3. Trial registryClinicalTrials.gov

    ALS trial posted on ClinicalTrials.gov

    The Phase 1b/2 trial of NB-4746 in about 80 people with ALS was registered. The registry later listed 4 March 2026 as its start date.

2025

  1. Press releaseFrom the companyNura Bio

    New medical chief hired to run patient trials

    Nura Bio named Lahar Mehta, formerly of Amylyx, as Chief Medical Officer to lead testing of NB-4746 in patients. No disease was named yet.

2024

  1. Press releaseFrom the companyNura Bio

    Healthy-volunteer study finished; new funding raised

    Nura Bio said NB-4746 was well tolerated in healthy volunteers and reached the spinal fluid, raised $68 million more, and moved its planned patient trial to 2025.

2023

  1. Press releaseFrom the companyNura Bio

    First human study of NB-4746 starts in healthy volunteers

    Nura Bio began a Phase 1 safety study in healthy volunteers and said it expected to start a trial in patients in 2024.

All sources for this page

  1. A Phase 1b/2 Study to Evaluate NB-4746 in Participants With ALS (NCT07369076)ClinicalTrials.gov · 17 Sept 2026 · Trial registry
  2. A Phase 1b/2 Study to Evaluate NB-4746 in Participants with ALS (NL-OMON61205)Overview of Medical Research in the Netherlands · 22 Oct 2026 · Trial registry
  3. Phase 1 SAD and MAD study of NB-4746 in healthy volunteers (ACTRN12623000476639)ANZCTR · Trial registry
  4. Phase 1 drug-drug interaction study of NB-4746 in healthy volunteers (ACTRN12624001072505)ANZCTR · Trial registry
  5. Nura Bio Initiates Phase I Clinical Trial for its Oral, Brain-Penetrant SARM1 Inhibitor, NB-4746Nura Bio · 25 Aug 2023 · Company press release
  6. Nura Bio Closes Series A Financing with $68 Million in New Funds, Bringing Total Raised to $140+ MillionNura Bio · 17 Sept 2024 · Company press release
  7. Nura Bio Expands Leadership Team with C-Suite AppointmentsNura Bio · 18 Feb 2025 · Company press release
  8. Nura Bio Completes $73.8M Series B Financing and Advances Pipeline of SARM1 InhibitorsNura Bio (GlobeNewswire) · 22 Jun 2026 · Company press release
  9. Neuro Startup Nura Bio Adds $68M to Spare Axons With Its Brain-Penetrating DrugMedCity News · News
  10. Nura raises $74M for ALS trial, new nerve-protecting therapyALS News Today · News
  11. Clinical Research & Trials Update, August 2026ALS Society of Canada · 1 Sept 2026 · Patient organisation
  12. Enrichment of SARM1 alleles encoding variants with constitutively hyperactive NADase in patients with ALS and other motor nerve disorderseLife · 19 Nov 2021 · Peer-reviewed paper
  13. Constitutively active SARM1 variants that induce neuropathy are enriched in ALS patientsMolecular Neurodegeneration · 6 Jan 2022 · Peer-reviewed paper
  14. Loss of Sarm1 does not suppress motor neuron degeneration in the SOD1G93A mouse model of ALSHuman Molecular Genetics · Peer-reviewed paper
  15. New Regimen for Inclusion in the HEALEY ALS Platform Trial with Eli Lilly and Company (LY3873862)Sean M. Healey & AMG Center for ALS, Mass General · News