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Arbaclofen Placarbil MR Prototype B

Indivior Inc. · Phase 1 active Small molecule Quality 40/100

Arbaclofen Placarbil MR Prototype B is a GABA-B receptor agonist Small molecule drug developed by Indivior Inc.. It is currently in Phase 1 development.

Arbaclofen placarbil is a prodrug that is converted to arbaclofen, a GABA-B receptor agonist that modulates neurotransmission in the central nervous system.

Likelihood of approval
9.6% vs 9.6% industry baseline
If approved by FDA: likely 2033–2036
Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 1 → approval rate +9.6pp
    Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2033–2036 —
EMA EU 2034–2037 +0.7 yr
MHRA GB 2034–2037 +0.7 yr
Health Canada CA 2034–2038 +0.9 yr
TGA AU 2034–2038 +1.2 yr
PMDA JP 2034–2038 +1.5 yr
NMPA CN 2035–2039 +2.3 yr
MFDS KR 2034–2038 +1.4 yr
CDSCO IN 2034–2039 +1.8 yr
ANVISA BR 2035–2039 +2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic nameArbaclofen Placarbil MR Prototype B
SponsorIndivior Inc.
Drug classGABA-B receptor agonist
ModalitySmall molecule
PhasePhase 1

Mechanism of action

Upon administration, arbaclofen placarbil is absorbed and converted to arbaclofen, the pharmacologically active R-enantiomer of baclofen. Arbaclofen selectively activates GABA-B receptors, inhibiting neurotransmitter release and reducing neuronal excitability. The modified-release formulation aims to provide sustained drug exposure.

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial enrolment, design, endpoints, results

Competitive intelligence

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Frequently asked questions about Arbaclofen Placarbil MR Prototype B

What is Arbaclofen Placarbil MR Prototype B?

Arbaclofen Placarbil MR Prototype B is a GABA-B receptor agonist drug developed by Indivior Inc..

How does Arbaclofen Placarbil MR Prototype B work?

Arbaclofen placarbil is a prodrug that is converted to arbaclofen, a GABA-B receptor agonist that modulates neurotransmission in the central nervous system.

Who makes Arbaclofen Placarbil MR Prototype B?

Arbaclofen Placarbil MR Prototype B is developed by Indivior Inc. (see full Indivior Inc. pipeline at /company/indivior-inc).

What drug class is Arbaclofen Placarbil MR Prototype B in?

Arbaclofen Placarbil MR Prototype B belongs to the GABA-B receptor agonist class. See all GABA-B receptor agonist drugs at /class/gaba-b-receptor-agonist.

What development phase is Arbaclofen Placarbil MR Prototype B in?

Arbaclofen Placarbil MR Prototype B is in Phase 1.

Related

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