Anle138b (emrusolmin)

The research record

This is the project's file for this landmark, as written and checked. Sources are listed at the end; anything not yet confirmed is marked "Not yet verified".

Who

MODAG GmbH (Germany), founded around Armin Giese and Christian Griesinger's work, licensed to Teva (the drug is also called TEV-56286 and emrusolmin). Phase 1 paper: Levin and colleagues, eBioMedicine 2022. The UK Parkinson's Phase 1b was supported by the Michael J. Fox Foundation (Alzforum).

What happened

• Oligomers are small clumps of synuclein that landmark 92 found to be the most toxic form. Anle138b is a small molecule that sticks to them and stops them forming. In mice with synuclein disease it slowed damage.
• Phase 1 (healthy adults, Nottingham; NCT04208152, Dec 2019–Aug 2020). 68 volunteers in a randomised, placebo-controlled study of single and multiple doses. Blood levels reached those that worked in a mouse Parkinson's model (per the paper's title). Alzforum reports no side effects at doses up to 300 mg a day and a half-life of about 12 hours. Published 2022.
• Phase 1b in people with Parkinson's (Nottingham; NCT04685265, Dec 2020–Dec 2022). Randomised, double-blind, placebo-controlled; 70 enrolled. Daily doses from 150 mg for 7 to 28 days; safety, blood and spinal-fluid levels and motor function were measured. No results found (Alzforum, page updated Oct 2025, says none released).
• Phase 2. Teva's TOPAS-MSA (NCT06568237) is in multiple system atrophy: started 2 Oct 2024, 349 enrolled, 300 mg daily or placebo for a year per Alzforum, main measure the UMSARS Part I score; active, not recruiting, primary completion estimated September 2027. An open-label extension (NCT07197866) is recruiting. No Parkinson's Phase 2 is registered.

• MJFF funding (2020). In August 2020 the Foundation awarded MODAG nearly $1.4 million for the Parkinson's trial, after the healthy-volunteer Phase 1 finished; MJFF's post said patients would enrol at one UK site in early 2021, and MODAG announced the first patients dosed in December 2020 (MJFF, MODAG release, 5 Aug 2020).

Why it moved us toward a cure

It is the main attempt to drug the toxic form identified in landmark 92 with a pill, as opposed to an antibody such as landmark 63.

Outcome

Open. Safe in short trials; no efficacy data in Parkinson's, and the programme has moved to MSA.

Sources

• Levin et al., eBioMedicine 2022;80:104021, DOI 10.1016/j.ebiom.2022.104021
• Registry: NCT04208152 · NCT04685265 · NCT06568237 (read via API, 19 Oct 2026)
• Alzforum therapeutics page
• Teva TOPAS-MSA page
• Both registered studies (NCT04208152, 68 people; NCT04685265, 70 people) are listed as Phase 1 (API 22 Oct 2026); the frontmatter has no n because there are two studies. Not yet verified: Phase 1b results; whether any Parkinson's Phase 2 is planned; the Phase 1 safety details beyond Alzforum's summary.