Last reviewed 2026-05-29 · How we verify

Paxarel (ACECARBROMAL)

Phase 2 active Small molecule ✓ Verified May 2026

Paxarel (generic name: ACECARBROMAL) is a drug. It is currently in Phase 2 development.

Paxarel is thought to work by modulating the activity of certain neurotransmitters in the brain.

Paxarel is a small molecule. It is also known by the synonyms ABASIN, ACECARBROMAL, and SEDAMYL.

Likelihood of approval

12.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
CNS / neurology attrition -3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	ACECARBROMAL
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

In simple terms, Paxarel is believed to affect the way that brain cells communicate with each other, which can help to reduce anxiety and promote relaxation. This is achieved by influencing the levels and activity of chemicals called neurotransmitters, such as GABA and glutamate, which play a crucial role in regulating mood and emotional responses.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

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

Paxarel CI brief — competitive landscape report
Paxarel updates RSS · CI watch RSS

Frequently asked questions about Paxarel

What is Paxarel?

Paxarel (ACECARBROMAL) is a Small molecule drug.

How does Paxarel work?

Paxarel is thought to work by modulating the activity of certain neurotransmitters in the brain.

What is the generic name of Paxarel?

ACECARBROMAL is the generic (nonproprietary) name of Paxarel.

What development phase is Paxarel in?

Paxarel is in Phase 2.

Therapeutic area: All drugs in Neuroscience

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