Arbaclofen

Phase 3Small molecule

SSeaside Therapeutics, Inc.

Arbaclofen is one of 124 small molecule programs targeting Spasticity. It is currently in Phase 3.

Indications

Total Trials

Active Trials

123

Competitors

Pipeline

Status by Indication[3][1]

Indication

SpasticityActive, not recruiting

Fragile X SyndromeActive, not recruiting

Autism Spectrum DisorderActive, not recruiting

Multiple SclerosisActive, not recruiting

SpasticityPhase 3

Active, not recruiting

Fragile X SyndromePhase 3

Active, not recruiting

Autism Spectrum DisorderPhase 2

Active, not recruiting

Multiple SclerosisPhase 3

Active, not recruiting

Competition

Competitive Landscape

560 competitors in Multiple Sclerosis

#DrugCompanyPhaseTrials

Arbaclofen

SSeaside Therapeutics, Inc.

Phase 3

3 2

Betaseron

Bayer

Preclinical

16 3

Kesimpta

Novartis

Preclinical

15 4

Tysabri

Biogen

Preclinical

14 5

Avonex

EMD Serono

Preclinical

22 6

Campath

GGenzyme, a Sanofi Company

Preclinical

12 7

Zinbryta

Roche

Preclinical

2 8

Flomax

Sanofi

Preclinical

1 9

Novantrone

Pred Forte

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2028

Phase 3Not yet recruiting

Multiple Sclerosis

NCT05179577

Clinical

Trials by Indication[1]

Fragile X Syndrome4 trials

An Open Label Extension Study of STX209 in Subjects With Fragile X Syndrome

Terminated·SSeaside Therapeutics, Inc.·Phase 2·NCT01013480·45 enrolled

An Open Label Extension Study in Subjects With Fragile X Syndrome

Terminated·SSeaside Therapeutics, Inc.·Phase 3·NCT01555333·357 enrolled

Efficacy and Safety Study of STX209 (Arbaclofen) for the Treatment of Social Withdrawal in Children With Fragile X Syndrome

Completed·SSeaside Therapeutics, Inc.·Phase 3·NCT01325220·172 enrolled

Show 1 more trial

Efficacy and Safety Study of STX209 (Arbaclofen) for Social Withdrawal in Adolescents and Adults With Fragile X Syndrome

Completed·SSeaside Therapeutics, Inc.·Phase 3·NCT01282268·125 enrolled

Autism Spectrum Disorder3 trials

Study of Arbaclofen for the Treatment of Social Withdrawal in Subjects With Autism Spectrum Disorders

Completed·SSeaside Therapeutics, Inc.·Phase 2·NCT01288716·150 enrolled

An Open Label Extension Study of STX209 in Subjects With Autism Spectrum Disorders

Terminated·SSeaside Therapeutics, Inc.·Phase 2·NCT01064973·32 enrolled

Open-Label Study of the Safety and Tolerability of STX209 in Subjects With Autism Spectrum Disorders

Completed·SSeaside Therapeutics, Inc.·Phase 2·NCT00846547·32 enrolled

Multiple Sclerosis3 trials

One Year, Open Label, Dose Escalation Long-term Safety Study in Multiple Sclerosis (MS) Subjects With Spasticity

Completed·RRVL Pharmaceuticals, Inc.·Phase 3·NCT01844232·150 enrolled

Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis

Completed·RRVL Pharmaceuticals, Inc.·Phase 3·NCT01743651·353 enrolled

A Study to Investigate Arbaclofen ER Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis

Not yet recruiting·RRVL Pharmaceuticals, Inc.·Phase 3·NCT05179577·442 enrolled

Adolescent2 trials

Arbaclofen in Children and Adolescents With ASD

Completed·—·Phase 2·NCT03682978·124 enrolled

Arbaclofen vs. Placebo in the Treatment of Children and Adolescents With ASD (ARBA)

Completed·HHolland Bloorview Kids Rehabilitation Hospital·Phase 2·NCT03887676·90 enrolled

Efficacy1 trial

Safety, Tolerability, and Efficacy of Arbaclofen in 16p11.2 Deletion

Active, not recruiting·CClinical Research Associates, LLC·Phase 2·NCT04271332·60 enrolled

2 more indications

Spasticity1 trial

A Study to Evaluate the Long-term Safety of Arbaclofen Extended-Release Tablets for Patients With Spasticity Due to MS

Completed·RRVL Pharmaceuticals, Inc.·Phase 3·NCT03319732·323 enrolled

Effectiveness1 trial

A Study to Investigate the Safety and Effectiveness of Arbaclofen Extended-Release Tablets for Patients With MS

Completed·RRVL Pharmaceuticals, Inc.·Phase 3·NCT03290131·536 enrolled

Sources

References

[1]
ClinicalTrials.gov — 15 trial records for Arbaclofen. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Arbaclofen compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Arbaclofen. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Seaside Therapeutics, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: SSeaside Therapeutics, Inc.

Arbaclofen

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2028

Trials by Indication[1]

Fragile X Syndrome4 trials

Autism Spectrum Disorder3 trials

Multiple Sclerosis3 trials

Adolescent2 trials

Efficacy1 trial

Spasticity1 trial

Effectiveness1 trial

References

Drug Info

Quick Facts

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