Stopped
Triumeq
Also known as dolutegravir/abacavir/lamivudine, Lighthouse II
Bottom line
A small open-label study hinted at slower decline, but the large placebo-controlled Phase 3 trial found Triumeq did not help people with ALS live longer. It is not being pursued for ALS; full Phase 3 results are still to be published.
Triumeq is a standard HIV pill that was tested in ALS because ancient virus genes hidden in our DNA (HERVs) may switch on and harm nerve cells. A small open-label study looked promising, so a large placebo-controlled Phase 3 trial, Lighthouse II, enrolled 419 people. In April 2025 it was stopped early because a planned check showed Triumeq did not help people live longer.
Information checked 5 Nov 2026
Evidence: Not shown to work
Studies: 1 against · 1 mixed
Controlled trials found no benefit.
Lighthouse II (Phase 3)No benefit
Stopped early in April 2025 after a planned interim analysis showed no survival benefit, the main goal, compared with placebo. Detailed numbers have not been published yet.
Lighthouse (Phase 2a)Mixed
The main goal was safety, and Triumeq was well tolerated over 24 weeks. Decline on the ALSFRS-R seemed about 22% slower than before treatment, but the range included no effect and there was no placebo group.
At a glance
CompanyMacquarie University with King's College London and TRICALSExplanation and sources
Lighthouse II was an academic trial, not a company project. Macquarie University in Sydney was the official sponsor, working with King's College London and the European TRICALS network. It ran at 29 centres in Europe, the UK, Australia and New Zealand.
Sources
- Triumeq in Amyotrophic Lateral Sclerosis, LIGHTHOUSE II (NCT05193994)ClinicalTrials.gov · Trial registry
- Lighthouse II study terminated after interim analysisTRICALS · 5 Apr 2025 · Company press release
How it worksHIV drug combination aimed at reawakened ancient virus genesHuman endogenous retrovirus K (HERV-K)Explanation and sources
Our DNA carries genes left behind by ancient viral infections. The researchers think some of these (HERVs) are switched back on in people with ALS and can kill nerve cells. Triumeq combines three HIV drugs (dolutegravir, abacavir and lamivudine) that block retroviruses, so the idea was that it might stop this HERV activity.
Sources
- Lighthouse II study terminated after interim analysisTRICALS · 5 Apr 2025 · Company press release
- Lighthouse IIUK MND Clinical Studies Group · Patient organisation
- Triumeq in Amyotrophic Lateral Sclerosis, LIGHTHOUSE II (NCT05193994)ClinicalTrials.gov · Trial registry
StageDiscontinuedPhase 3 stopped early in April 2025 for lack of benefitExplanation and sources
Lighthouse II started in February 2022, finished recruiting in 2024 with 419 people, and was terminated on 5 April 2025 after a planned interim analysis. Everyone was told to stop the study drug. A summary of results was filed in the EU trial system in March 2026, but we could not find a full published paper as of November 2026.
Sources
- Triumeq in Amyotrophic Lateral Sclerosis, LIGHTHOUSE II (NCT05193994)ClinicalTrials.gov · Trial registry
- Lighthouse II study terminated after interim analysisTRICALS · 5 Apr 2025 · Company press release
- Lighthouse IIUK MND Clinical Studies Group · Patient organisation
- Lighthouse II EU trial record with summary of results (2024-517054-94-00)CTIS.eu · Trial registry
What happenedPhase 3 Lighthouse II stopped after interim analysis showed no survival benefit5 Apr 2025Explanation and sources
On 5 April 2025 TRICALS, King's College London and Macquarie University announced the trial was terminated because the interim analysis showed no benefit on survival. Patient organisations in the UK and Australia concluded Triumeq is not believed to help people with ALS/MND. Full results are still to be published.
Sources
- Lighthouse II study terminated after interim analysisTRICALS · 5 Apr 2025 · Company press release
- Triumeq treatment trialMND Association · Patient organisation
- Clinical trial update: Lighthouse II study discontinuedMND Australia · Patient organisation
Best reported effectNo survival benefit vs placebo (Phase 3)Overall survival (primary endpoint)Explanation and sources
The main goal was to see whether Triumeq helped people live longer. A planned interim look at the data showed no difference in survival between Triumeq and placebo, so the trial was stopped. The earlier Phase 2 Lighthouse study had hinted at slower decline, but it was small and had no placebo group, which is why a large placebo-controlled trial was needed.
Sources
- Lighthouse II study terminated after interim analysisTRICALS · 5 Apr 2025 · Company press release
- Triumeq treatment trialMND Association · Patient organisation
- Triumeq in Amyotrophic Lateral Sclerosis, LIGHTHOUSE II (NCT05193994)ClinicalTrials.gov · Trial registry
- Safety and tolerability of Triumeq in amyotrophic lateral sclerosis: the Lighthouse trialAmyotrophic Lateral Sclerosis and Frontotemporal Degeneration · Peer-reviewed paper
Who it's forAdults with ALS (Europe, UK, Australia, New Zealand)All ALS · Pill, once dailyExplanation and sources
The trial enrolled adults with ALS and excluded people who carry the HLA-B*5701 gene variant, because they can have serious allergic reactions to abacavir, one of Triumeq's ingredients.
Sources
- Triumeq in Amyotrophic Lateral Sclerosis, LIGHTHOUSE II (NCT05193994)ClinicalTrials.gov · Trial registry
- Lighthouse II EU Clinical Trials Register entry (2020-005069-15)EU Clinical Trials Register · Trial registry
Can I join?Trial stopped; not recommended for ALSExplanation and sources
No Triumeq trial for ALS is running. Triumeq is an approved HIV medicine, but the Phase 3 trial found no benefit in ALS, and participants were asked to stop taking it.
- Lighthouse II (Phase 3) (NCT05193994) terminated · Australia, New Zealand, UK, Europe
Sources
- Triumeq in Amyotrophic Lateral Sclerosis, LIGHTHOUSE II (NCT05193994)ClinicalTrials.gov · Trial registry
- Lighthouse II study terminated after interim analysisTRICALS · 5 Apr 2025 · Company press release
Timeline
6 events, newest first. Company updates are marked; independent news and regulator decisions are shown too.
2026
Summary of results filed in EU trial system
A summary of results was submitted to the EU Clinical Trials Information System. A full journal paper had not appeared as of November 2026.
2025
Registry lists trial as terminated
ClinicalTrials.gov records 30 June 2025 as the trial's completion date, with status terminated.
UK MND Research Institute explains the result
The institute said Triumeq did not provide a survival benefit and that the full dataset is being analysed.
Lighthouse II stopped for lack of benefit
The trial sponsors announced that a planned interim analysis showed Triumeq did not improve survival compared with placebo. Participants were told to stop the drug.
2024
UK recruitment ends
Recruitment closed in the UK; the trial enrolled 419 people worldwide.
2022
Lighthouse II Phase 3 starts
The placebo-controlled trial of Triumeq in ALS began, led by Macquarie University with King's College London and TRICALS.
All sources for this page
- Lighthouse II study terminated after interim analysisTRICALS · 5 Apr 2025 · Company press release
- Triumeq in Amyotrophic Lateral Sclerosis, LIGHTHOUSE II (NCT05193994)ClinicalTrials.gov · Trial registry
- Lighthouse IIUK MND Clinical Studies Group · Patient organisation
- Triumeq treatment trialMND Association · Patient organisation
- Clinical trial update: Lighthouse II study discontinuedMND Australia · Patient organisation
- Lighthouse II EU trial record with summary of results (2024-517054-94-00)CTIS.eu · Trial registry
- Safety and tolerability of Triumeq in amyotrophic lateral sclerosis: the Lighthouse trialAmyotrophic Lateral Sclerosis and Frontotemporal Degeneration · Peer-reviewed paper
- Lighthouse Phase 2a open-label study of Triumeq in ALS (NCT02868580)ClinicalTrials.gov · Trial registry
- Lighthouse II EU Clinical Trials Register entry (2020-005069-15)EU Clinical Trials Register · Trial registry