NCT06365216 (SEALS) is a Phase 2 clinical trial of NX210c in Amyotrophic Lateral Sclerosis, sponsored by Axoltis Pharma.

Who is sponsoring NCT06365216?

NCT06365216 is sponsored by Axoltis Pharma.

What drugs are being tested in NCT06365216?

Interventions in NCT06365216: NX210c, Placebo.

What condition does NCT06365216 study?

NCT06365216 studies Amyotrophic Lateral Sclerosis.

Is NCT06365216 still recruiting?

NCT06365216 is currently active, enrolled. Last updated 24 December 2025.

Last reviewed 2025-12-24 · How we verify

NCT06365216: SEALS

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

ALS Phase II Study of NX210c

Active, enrolled Phase 2 Last updated 24 December 2025

What this trial tests

Phase 2 trial testing NX210c in Amyotrophic Lateral Sclerosis in 80 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

25 October 2024

Primary endpoint
1 February 2026

30 September 2026

Quick facts

Lead sponsor	Axoltis Pharma
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	80
Start date	25 October 2024
Primary completion	1 February 2026
Estimated completion	30 September 2026
Sites	16 locations across France

Drugs / interventions tested

NX210c — full drug profile →
Placebo

Conditions studied

Amyotrophic Lateral Sclerosis — all drugs for Amyotrophic Lateral Sclerosis →

Sponsor

Axoltis Pharma — full company profile →

Who can join

18 and older, any sex, with Amyotrophic Lateral Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will investigate the efficacy, safety, tolerability and pharmacokinetics (PK) of multiple intravenous infusions of NX210c, at two dose levels, in patients with Amyotrophic lateral sclerosis (ALS).

Publications & conference data

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

Restoring brain barriers: an innovative approach for treating neurological disorders.
Lemarchant S, Engelhardt B, Cicchetti F, Bix GJ, et al · · 2025 · cited 5× · PMID 40640916 · DOI 10.1186/s12987-025-00688-z
Safety, Tolerability and Pharmacokinetic-Pharmacodynamic Relationship of NX210c Peptide in Healthy Elderly Volunteers: Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study.
Janus A, Dumas D, Le Douce J, Marie S, et al · · 2025 · cited 4× · PMID 39708220 · DOI 10.1007/s40120-024-00691-w
NX210c drug candidate peptide strengthens mouse and human blood-brain barriers.
Greene C, Rebergue N, Fewell G, Janigro D, et al · · 2024 · cited 4× · PMID 39334382 · DOI 10.1186/s12987-024-00577-x
Genetic and Mechanistic Insights Inform Amyotrophic Lateral Sclerosis Treatment and Symptomatic Management: Current and Emerging Therapeutics and Clinical Trial Design Considerations.
Quigley SE, Quigg KH, Goutman SA. · · 2025 · cited 2× · PMID 40897992 · DOI 10.1007/s40263-025-01217-0
Programmable self-replicating JEV nanotherapeutics redefine RNA delivery in ALS.
Loo YS, Yusoh NA, Yap K, Ng CS. · · 2025 · PMID 40858858 · DOI 10.1038/s42003-025-08579-7
CNS Summit 2024: Abstracts of Poster Presentations
· 2024

Verify or expand the search:

Other trials of NX210c

Trials testing the same drug.

NCT05827653 — MAD Study of NX210c · Phase 1 · completed

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

Other Axoltis Pharma trials

Trials by the same sponsor.

NCT05827653 — MAD Study of NX210c · Phase 1 · completed

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 NCT06365216 (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 Axoltis Pharma
Last refreshed: 24 December 2025

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/NCT06365216.

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