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.
NB-4746-201 (Phase 1b/2a in ALS, NCT07369076)Pending
About 80 people with ALS get NB-4746 or placebo: two doses for 28 days, then one dose for 12 weeks, then an optional open-label extension up to a year. Main goal is safety; NfL is also measured.
NB-4746 Phase 1 in healthy volunteers (ACTRN12623000476639)Pending
Single doses or 10 days of NB-4746 or placebo in 66 healthy adults in Australia. The company reported it was well tolerated with no serious side effects and reached spinal fluid; full results are not published. No one with ALS took part.
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.
Sources
- 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
- Nura Bio Completes $73.8M Series B Financing and Advances Pipeline of SARM1 InhibitorsNura Bio (GlobeNewswire) · 22 Jun 2026 · Company press release
- Nura raises $74M for ALS trial, new nerve-protecting therapyALS News Today · News
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.
Sources
- Nura Bio Completes $73.8M Series B Financing and Advances Pipeline of SARM1 InhibitorsNura Bio (GlobeNewswire) · 22 Jun 2026 · Company press release
- 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
- Constitutively active SARM1 variants that induce neuropathy are enriched in ALS patientsMolecular Neurodegeneration · 6 Jan 2022 · Peer-reviewed paper
- Loss of Sarm1 does not suppress motor neuron degeneration in the SOD1G93A mouse model of ALSHuman Molecular Genetics · Peer-reviewed paper
- 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
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.
Sources
- A Phase 1b/2 Study to Evaluate NB-4746 in Participants With ALS (NCT07369076)ClinicalTrials.gov · 17 Sept 2026 · Trial registry
- 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
- Nura Bio Completes $73.8M Series B Financing and Advances Pipeline of SARM1 InhibitorsNura Bio (GlobeNewswire) · 22 Jun 2026 · Company press release
- Phase 1 SAD and MAD study of NB-4746 in healthy volunteers (ACTRN12623000476639)ANZCTR · Trial registry
- Phase 1 drug-drug interaction study of NB-4746 in healthy volunteers (ACTRN12624001072505)ANZCTR · Trial registry
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.
Sources
- 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
- Nura Bio Completes $73.8M Series B Financing and Advances Pipeline of SARM1 InhibitorsNura Bio (GlobeNewswire) · 22 Jun 2026 · Company press release
- Neuro Startup Nura Bio Adds $68M to Spare Axons With Its Brain-Penetrating DrugMedCity News · News
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
- 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
- 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.
- NB-4746-201 (NCT07369076) recruiting · Australia (Sydney, Brisbane, Adelaide, Melbourne, Perth), Canada, Netherlands, Poland
- NB-4746 Phase 1 (healthy volunteers) (ACTRN12623000476639) completed · Australia
Sources
- A Phase 1b/2 Study to Evaluate NB-4746 in Participants With ALS (NCT07369076)ClinicalTrials.gov · 17 Sept 2026 · Trial registry
- 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 update | 22 Jun 2026 (4 months ago) | 12 / 40 |
|---|---|---|
| Company updates in the last 12 months | 1 | 6 / 35 |
| Promises kept | 0 of 2 on time | 13 / 25 |
| Signal score | 31 / 100 · Quiet | |
Announced milestones
- Delivered late Start a Phase 1b/2 trial of NB-4746 in patients (promised for 2024, delivered 4 Mar 2026)
- Delivered late Start a Phase 1b/2 trial of NB-4746 in patients (renewed promise) (promised for 2025, delivered 4 Mar 2026)
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
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.
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.
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
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
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
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
- A Phase 1b/2 Study to Evaluate NB-4746 in Participants With ALS (NCT07369076)ClinicalTrials.gov · 17 Sept 2026 · Trial registry
- 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
- Phase 1 SAD and MAD study of NB-4746 in healthy volunteers (ACTRN12623000476639)ANZCTR · Trial registry
- Phase 1 drug-drug interaction study of NB-4746 in healthy volunteers (ACTRN12624001072505)ANZCTR · Trial registry
- Nura Bio Initiates Phase I Clinical Trial for its Oral, Brain-Penetrant SARM1 Inhibitor, NB-4746Nura Bio · 25 Aug 2023 · Company press release
- 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
- Nura Bio Expands Leadership Team with C-Suite AppointmentsNura Bio · 18 Feb 2025 · Company press release
- Nura Bio Completes $73.8M Series B Financing and Advances Pipeline of SARM1 InhibitorsNura Bio (GlobeNewswire) · 22 Jun 2026 · Company press release
- Neuro Startup Nura Bio Adds $68M to Spare Axons With Its Brain-Penetrating DrugMedCity News · News
- Nura raises $74M for ALS trial, new nerve-protecting therapyALS News Today · News
- Clinical Research & Trials Update, August 2026ALS Society of Canada · 1 Sept 2026 · Patient organisation
- 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
- Constitutively active SARM1 variants that induce neuropathy are enriched in ALS patientsMolecular Neurodegeneration · 6 Jan 2022 · Peer-reviewed paper
- Loss of Sarm1 does not suppress motor neuron degeneration in the SOD1G93A mouse model of ALSHuman Molecular Genetics · Peer-reviewed paper
- 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