ALS Tracker

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Early pipeline

QRL-101

Bottom line

Early: safe so far, and one dose calmed nerve overexcitability in 12 people with ALS. Whether it slows ALS has not been tested; a Phase 2 trial is planned but not funded or dated.

Very early. This drug is in its first safety trial in people and has not been tested for whether it helps in ALS. Most drugs at this stage never reach approval. More about early drugs

QRL-101 is an experimental drug taken by mouth that is meant to calm overexcited motor nerves by opening potassium channels called Kv7.2/7.3. Phase 1 studies have given it to about 200 people, including a single dose in 12 people with ALS, where it reduced a measure of nerve overexcitability. It has not yet been tested for whether it slows ALS.

Information checked 5 Nov 2026

Evidence: Results pending

Studies: 1 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

CompanyQurAlisExplanation and sources

QurAlis is a private biotech in Cambridge, Massachusetts, focused on ALS and related diseases. QRL-101 was licensed from Eli Lilly. QurAlis is also developing it for epilepsy. The company says planning for a Phase 2 trial in ALS is under way, depending on new funding.

Sources

  1. QurAlis corporate presentation, September 2026QurAlis · Company website
  2. QurAlis QRL-201 and QRL-101 data summary, Target ALS meeting (May 2026)QurAlis · Company website
  3. QurAlis announces topline data from its Phase 1 clinical trial of QRL-101 evaluating biomarkers of ALS and epilepsy in healthy volunteersQurAlis · 12 Mar 2025 · Company press release
How it worksDrug taken by mouth, meant to calm overexcited motor nervesKv7.2/7.3 potassium channel openerExplanation and sources

In many people with ALS, motor nerves are overexcitable: they fire too easily, which may speed up their damage. Kv7.2/7.3 channels act as brakes on nerve firing, and loss of TDP-43 in ALS can leave nerve cells short of them. QRL-101 is designed to open these channels. An older drug of this type, ezogabine, was used for epilepsy but was withdrawn because of side effects.

Sources

  1. QRL-101 reduces motor neuron excitability in healthy volunteersALS News Today · 20 Mar 2025 · News
  2. QurAlis corporate presentation, September 2026QurAlis · Company website
  3. QurAlis confirms signal of target engagement in ALS patients in Phase 1 clinical trial of QRL-101QurAlis · 29 Dec 2025 · Company press release
StagePhase 1Phase 1 done in about 200 people, 12 of them with ALS · Dosing: healthy volunteers and people with alsExplanation and sources

QurAlis has run several Phase 1 studies, mostly in healthy volunteers, testing single and repeated doses, a nerve-excitability study, and a new formulation finished in August 2026. One study gave a single dose to 12 people with ALS in Utrecht, the Netherlands. A Phase 2 trial in ALS is being planned but has no start date.

Sources

  1. QurAlis corporate presentation, September 2026QurAlis · Company website
  2. Single-dose study of QRL-101 in people with ALS (QRL-101-04, NCT06714396)ClinicalTrials.gov · Trial registry
  3. Repeated-dose study of a new QRL-101 formulation in healthy volunteers (QRL-101-08, NCT07421778)ClinicalTrials.gov · Trial registry
  4. QurAlis confirms signal of target engagement in ALS patients in Phase 1 clinical trial of QRL-101QurAlis · 29 Dec 2025 · Company press release
Best reported effectSafety study; no effect data yetNerve excitability after a single doseExplanation and sources

In the 12-person ALS study, a single dose reduced measures of nerve overexcitability compared with placebo, with no serious side effects. The study was too small to prove a difference and could not show anything about disease progression. In healthy volunteers it reduced nerve excitability, but missed one of its two main measures. These results come from company press releases, not a peer-reviewed paper.

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

Sources

  1. QurAlis confirms signal of target engagement in ALS patients in Phase 1 clinical trial of QRL-101QurAlis · 29 Dec 2025 · Company press release
  2. QurAlis announces topline data from its Phase 1 clinical trial of QRL-101 evaluating biomarkers of ALS and epilepsy in healthy volunteersQurAlis · 12 Mar 2025 · Company press release
  3. QRL-101 reduces motor neuron excitability in healthy volunteersALS News Today · 20 Mar 2025 · News
Who it's forAimed at ALS with overexcited motor nervesAll ALS · By mouthExplanation and sources

QurAlis is targeting people with ALS whose motor nerves are overexcitable, which it says is seen in about half of people with ALS. It has not limited the drug to any genetic form.

Sources

  1. QRL-101 reduces motor neuron excitability in healthy volunteersALS News Today · 20 Mar 2025 · News
  2. QurAlis corporate presentation, September 2026QurAlis · Company website
What's nextResults from the new-formulation study in healthy volunteersExpected Q4 2026Explanation and sources

QurAlis's September 2026 presentation says top-line results from the study of a new formulation are expected in the fourth quarter of 2026. It gives no date for a Phase 2 trial in ALS.

Sources

  1. QurAlis corporate presentation, September 2026QurAlis · Company website
  2. Repeated-dose study of a new QRL-101 formulation in healthy volunteers (QRL-101-08, NCT07421778)ClinicalTrials.gov · Trial registry
Can I join?No trial recruiting; Phase 2 in ALS is being plannedExplanation and sources

Both recent studies have finished, and none is open to people with ALS. We found no expanded access programme.

Sources

  1. Single-dose study of QRL-101 in people with ALS (QRL-101-04, NCT06714396)ClinicalTrials.gov · Trial registry
  2. Repeated-dose study of a new QRL-101 formulation in healthy volunteers (QRL-101-08, NCT07421778)ClinicalTrials.gov · Trial registry
  3. QurAlis corporate presentation, September 2026QurAlis · Company website

Signal: Quiet

Signal measures how often, and how reliably, QurAlis 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 update29 Dec 2025 (10 months ago)4 / 40
Company updates in the last 12 months16 / 35
Promises kept0 of 1 on time13 / 25
Signal score23 / 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

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

2025

  1. Press releaseFrom the companyQurAlis

    Single dose of QRL-101 reduces nerve overexcitability in people with ALS

    Top-line results from 12 people with ALS showed less nerve overexcitability than with placebo and no serious side effects. The study was not designed to prove a difference.

  2. NewsALS News Today

    ALS News Today reports the healthy-volunteer results

    Independent coverage of the nerve-excitability study, comparing QRL-101 with the older drug ezogabine.

  3. Press releaseFrom the companyQurAlis

    QRL-101 calms nerve excitability in healthy volunteers

    In 24 healthy adults, QRL-101 reduced a measure of motor nerve excitability linked to faster ALS, but missed a second main measure. No serious side effects.

2024

  1. Press releaseFrom the companyQurAlis

    First person with ALS dosed with QRL-101

    The single-dose study in about 12 people with ALS began in Utrecht. QurAlis expected top-line results in the first half of 2025.

  2. Press releaseFrom the companyQurAlis

    Repeated-dose study of QRL-101 starts in healthy volunteers

    QurAlis dosed the first group in a Phase 1 study of repeated, rising doses in healthy adults.

All sources for this page

  1. QurAlis doses first participant cohort in Phase 1 multiple ascending dose clinical trial evaluating QRL-101QurAlis · 10 Sept 2024 · Company press release
  2. QurAlis doses first patient with ALS in Phase 1 clinical trial evaluating QRL-101QurAlis · 4 Dec 2024 · Company press release
  3. QurAlis announces topline data from its Phase 1 clinical trial of QRL-101 evaluating biomarkers of ALS and epilepsy in healthy volunteersQurAlis · 12 Mar 2025 · Company press release
  4. QRL-101 reduces motor neuron excitability in healthy volunteersALS News Today · 20 Mar 2025 · News
  5. QurAlis confirms signal of target engagement in ALS patients in Phase 1 clinical trial of QRL-101QurAlis · 29 Dec 2025 · Company press release
  6. Single-dose study of QRL-101 in people with ALS (QRL-101-04, NCT06714396)ClinicalTrials.gov · Trial registry
  7. Repeated-dose study of a new QRL-101 formulation in healthy volunteers (QRL-101-08, NCT07421778)ClinicalTrials.gov · Trial registry
  8. QurAlis QRL-201 and QRL-101 data summary, Target ALS meeting (May 2026)QurAlis · Company website
  9. QurAlis corporate presentation, September 2026QurAlis · Company website