NCT04326283 is a Phase 1, PHASE2 clinical trial of Trametinib (0.5 mg) in Amyotrophic Lateral Sclerosis, sponsored by Genuv Inc..

Who is sponsoring NCT04326283?

NCT04326283 is sponsored by Genuv Inc..

What drugs are being tested in NCT04326283?

Interventions in NCT04326283: Trametinib (0.5 mg), Trametinib (1 mg), Riluzole (100 mg).

What condition does NCT04326283 study?

NCT04326283 studies Amyotrophic Lateral Sclerosis.

Is NCT04326283 still recruiting?

NCT04326283 is currently terminated. Last updated 9 May 2023.

Last reviewed 2023-05-09 · How we verify

NCT04326283

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Trial of Safety, Tolerability and Efficacy of Trametinib (SNR1611) in Patients With Amyotrophic Lateral Sclerosis (ALS)

Terminated Phase 1, PHASE2 Last updated 9 May 2023

What this trial tests

Phase 1, PHASE2 trial testing Trametinib (0.5 mg) in Amyotrophic Lateral Sclerosis in 23 participants. Terminated before completion.

Timeline

2 April 2020

Primary endpoint
28 April 2023

28 April 2023

Quick facts

Lead sponsor	Genuv Inc.
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	23
Start date	2 April 2020
Primary completion	28 April 2023
Estimated completion	28 April 2023
Sites	5 locations across South Korea

Drugs / interventions tested

Trametinib (0.5 mg) — full drug profile →
Trametinib (1 mg) — full drug profile →
Riluzole (100 mg) — full drug profile →

Conditions studied

Amyotrophic Lateral Sclerosis — all drugs for Amyotrophic Lateral Sclerosis →

Sponsor

Genuv Inc. — full company profile →

Who can join

Adults 19 to 75, any sex, with Amyotrophic Lateral Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the safety, tolerability and efficacy of trametinib (SNR1611) in the treatment of amyotrophic lateral sclerosis.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Amyotrophic lateral sclerosis: a neurodegenerative disorder poised for successful therapeutic translation.
Mead RJ, Shan N, Reiser HJ, Marshall F, et al · · 2023 · cited 323× · PMID 36543887 · DOI 10.1038/s41573-022-00612-2
Mitogen-Activated Protein Kinase Pathway in Amyotrophic Lateral Sclerosis.
Sahana TG, Zhang K. · · 2021 · cited 35× · PMID 34440173 · DOI 10.3390/biomedicines9080969
Effect of alpha-mangostin in the prevention of behavioural and neurochemical defects in methylmercury-induced neurotoxicity in experimental rats.
Sahu R, Mehan S, Kumar S, Prajapati A, et al · · 2022 · cited 27× · PMID 35783250 · DOI 10.1016/j.toxrep.2022.04.023
Protein kinases in neurodegenerative diseases: current understandings and implications for drug discovery.
Wu X, Yang Z, Zou J, Gao H, et al · · 2025 · cited 18× · PMID 40328798 · DOI 10.1038/s41392-025-02179-x
Inhibition of the MEK/ERK pathway suppresses immune overactivation and mitigates TDP-43 toxicity in a Drosophila model of ALS.
Yue W, Deng X, Wang Z, Jiang M, et al · · 2023 · cited 17× · PMID 37340309 · DOI 10.1186/s12979-023-00354-8
Amyotrophic Lateral Sclerosis Is Accompanied by Protein Derangements in the Olfactory Bulb-Tract Axis.
Lachén-Montes M, Mendizuri N, Ausin K, Andrés-Benito P, et al · · 2020 · cited 17× · PMID 33167591 · DOI 10.3390/ijms21218311
FDA-Approved Kinase Inhibitors in Preclinical and Clinical Trials for Neurological Disorders.
Lui A, Vanleuven J, Perekopskiy D, Liu D, et al · · 2022 · cited 15× · PMID 36558997 · DOI 10.3390/ph15121546
The role of autophagy in the pathogenesis and treatment of amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD).
Beckers J, Van Damme P. · · 2025 · cited 5× · PMID 40395983 · DOI 10.1080/27694127.2025.2474796

Verify or expand the search:

Other recruiting trials for Amyotrophic Lateral Sclerosis

Currently open trials in the same condition.

NCT07502677 — Diagnostic Accuracy of SleepImage Technology for Detecting Respiratory Failure in Patients With Amyotrophic Lateral Scle · recruiting
NCT07478172 — Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease · NA · recruiting
NCT07204977 — Acamprosate in C9orf72 Hexanucleotide Repeat Expansion Amyotrophic Lateral Sclerosis (ACALS) · Phase 1 · active not recruiting
NCT07290062 — A Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection (IT) of INS1202 in Participants · Phase 1 · recruiting
NCT07259980 — A Study to Learn More About the Long-Term Safety of Tofersen (Qalsody) in Participants With Superoxide Dismutase 1 (SOD- · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04326283 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Genuv Inc.
Last refreshed: 9 May 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04326283.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing