Last reviewed 2026-05-31 · How we verify

Arbaclofen Placarbil MR Prototype A

Indivior Inc. · Phase 1 active Small molecule ✓ Verified May 2026 Quality 0/100

Arbaclofen Placarbil MR Prototype A is a Small molecule drug developed by Indivior Inc.. It is currently in Phase 1 development.

Arbaclofen Placarbil MR Prototype A is a modified release formulation of Arbaclofen Placarbil, which is being studied in a Phase 1 bioavailability study in healthy volunteers. The study aims to evaluate the bioavailability of Arbaclofen Placarbil MR Prototype A, as well as two other modified release formulations, Arbaclofen Placarbil SR and Arbaclofen Placarbil MR Prototype B.

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 name	Arbaclofen Placarbil MR Prototype A
Sponsor	Indivior Inc.
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Phase 1 Bioavailability Study of Arbaclofen Placarbil Modified Release Formulations in Healthy Volunteers (PHASE1)

Primary sources

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

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Arbaclofen Placarbil MR Prototype A CI brief — competitive landscape report
Arbaclofen Placarbil MR Prototype A updates RSS · CI watch RSS
Indivior Inc. portfolio CI

Frequently asked questions about Arbaclofen Placarbil MR Prototype A

What is Arbaclofen Placarbil MR Prototype A?

Arbaclofen Placarbil MR Prototype A is a Small molecule drug developed by Indivior Inc..

Who makes Arbaclofen Placarbil MR Prototype A?

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

What development phase is Arbaclofen Placarbil MR Prototype A in?

Arbaclofen Placarbil MR Prototype A is in Phase 1.

Manufacturer: Indivior Inc. — full pipeline

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