BACLOFEN

Post-LOE

baclofen

MAIA Biotechnology

ANDAINTRATHECALINJECTABLE

Approved

Jan 2021

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

BACLOFEN (baclofen) by MAIA Biotechnology is gaba a agonists [moa]. Approved for multiple sclerosis. First approved in 2021.

Drug data last refreshed 20h ago

Mechanism of Action

GABA A Agonists

Pharmacologic Class:

gamma-Aminobutyric Acid-ergic Agonist

Indications (1)

multiple sclerosis

Clinical Trials (15)

NCT06606574N/ARecruiting

Intrathecal Baclofen and Pediatric Dystonia

Started Nov 2024

65 enrolled

Dystonic Cerebral Palsy

NCT03058237Phase 1Completed

A Phase 1 Bioavailability Study of Arbaclofen Placarbil Modified Release Formulations in Healthy Volunteers

Started Jan 2017

40 enrolled

Healthy Volunteers

NCT02903823Phase 4Completed

Intrathecal (IT) Baclofen Drug Distribution

Started Apr 2016

27 enrolled

Muscle Spasticity

NCT02511886Phase 2Completed

A Dose-Escalation Study to Determine the Maximum Tolerated Dose of Arbaclofen Placarbil in Subjects With Alcohol Use Disorder

Started Sep 2015

18 enrolled

Alcohol Use Disorder

NCT02705950N/ACompleted

Intrathecal Baclofen (ITB) Bolus on Neuropathic Pain (NP). Preliminary Study.

Started Dec 2014

12 enrolled

Neuropathic Pain

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.