Last reviewed 2026-05-18 · How we verify

Eltoprazine HCl

Amarantus BioScience Holdings, Inc. · Phase 2 active Small molecule Quality 45/100

Eltoprazine HCl is a Serotonin receptor agonist Small molecule drug developed by Amarantus BioScience Holdings, Inc.. It is currently in Phase 2 development.

Eltoprazine modulates serotonin receptors in the brain, particularly acting as an agonist at 5-HT1A and 5-HT1B receptors.

Likelihood of approval

15.3% 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).

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	Eltoprazine HCl
Sponsor	Amarantus BioScience Holdings, Inc.
Drug class	Serotonin receptor agonist
Modality	Small molecule
Phase	Phase 2

Mechanism of action

Eltoprazine functions as a serotonin receptor agonist with selectivity for 5-HT1A and 5-HT1B receptor subtypes. By modulating serotonergic neurotransmission, it may help regulate motor control and behavioral symptoms in neurological disorders.

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.

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:

Eltoprazine HCl CI brief — competitive landscape report
Eltoprazine HCl updates RSS · CI watch RSS
Amarantus BioScience Holdings, Inc. portfolio CI

Frequently asked questions about Eltoprazine HCl

What is Eltoprazine HCl?

Eltoprazine HCl is a Serotonin receptor agonist drug developed by Amarantus BioScience Holdings, Inc..

How does Eltoprazine HCl work?

Eltoprazine modulates serotonin receptors in the brain, particularly acting as an agonist at 5-HT1A and 5-HT1B receptors.

Who makes Eltoprazine HCl?

Eltoprazine HCl is developed by Amarantus BioScience Holdings, Inc. (see full Amarantus BioScience Holdings, Inc. pipeline at /company/amarantus-bioscience-holdings-inc).

What drug class is Eltoprazine HCl in?

Eltoprazine HCl belongs to the Serotonin receptor agonist class. See all Serotonin receptor agonist drugs at /class/serotonin-receptor-agonist.

What development phase is Eltoprazine HCl in?

Eltoprazine HCl is in Phase 2.

Drug class: All Serotonin receptor agonist drugs
Manufacturer: Amarantus BioScience Holdings, Inc. — full pipeline

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