Last reviewed 2026-04-22 · How we verify

Amisulpride, Moclobemide

Beersheva Mental Health Center · Phase 3 active Small molecule

Amisulpride, Moclobemide is a Atypical antipsychotic + Reversible MAOI Small molecule drug developed by Beersheva Mental Health Center. It is currently in Phase 3 development for Schizophrenia with depressive symptoms, Schizoaffective disorder.

This combination uses amisulpride (a dopamine D2/D3 antagonist) and moclobemide (a reversible monoamine oxidase-A inhibitor) to modulate dopaminergic and monoaminergic neurotransmission for psychiatric symptom management.

Likelihood of approval

55.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	Amisulpride, Moclobemide
Sponsor	Beersheva Mental Health Center
Drug class	Atypical antipsychotic + Reversible MAOI
Target	Dopamine D2/D3 receptors; Monoamine oxidase-A
Modality	Small molecule
Therapeutic area	Psychiatry
Phase	Phase 3

Mechanism of action

Amisulpride selectively blocks dopamine D2 and D3 receptors in the mesolimbic and mesocortical pathways, reducing psychotic symptoms and improving negative symptoms of schizophrenia. Moclobemide inhibits monoamine oxidase-A, increasing serotonin and noradrenaline availability, which enhances mood and reduces depressive symptoms. The combination targets both dopaminergic and monoaminergic systems to address multiple psychiatric symptom domains.

Approved indications

Schizophrenia with depressive symptoms
Schizoaffective disorder

Common side effects

Akathisia
Parkinsonism
Insomnia
Anxiety
Hypertension (moclobemide-related)
Nausea

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:

Amisulpride, Moclobemide CI brief — competitive landscape report
Amisulpride, Moclobemide updates RSS · CI watch RSS
Beersheva Mental Health Center portfolio CI

Frequently asked questions about Amisulpride, Moclobemide

What is Amisulpride, Moclobemide?

Amisulpride, Moclobemide is a Atypical antipsychotic + Reversible MAOI drug developed by Beersheva Mental Health Center, indicated for Schizophrenia with depressive symptoms, Schizoaffective disorder.

How does Amisulpride, Moclobemide work?

What is Amisulpride, Moclobemide used for?

Amisulpride, Moclobemide is indicated for Schizophrenia with depressive symptoms, Schizoaffective disorder.

Who makes Amisulpride, Moclobemide?

Amisulpride, Moclobemide is developed by Beersheva Mental Health Center (see full Beersheva Mental Health Center pipeline at /company/beersheva-mental-health-center).

What drug class is Amisulpride, Moclobemide in?

Amisulpride, Moclobemide belongs to the Atypical antipsychotic + Reversible MAOI class. See all Atypical antipsychotic + Reversible MAOI drugs at /class/atypical-antipsychotic-reversible-maoi.

What development phase is Amisulpride, Moclobemide in?

Amisulpride, Moclobemide is in Phase 3.

What are the side effects of Amisulpride, Moclobemide?

Common side effects of Amisulpride, Moclobemide include Akathisia, Parkinsonism, Insomnia, Anxiety, Hypertension (moclobemide-related), Nausea.

What does Amisulpride, Moclobemide target?

Amisulpride, Moclobemide targets Dopamine D2/D3 receptors; Monoamine oxidase-A and is a Atypical antipsychotic + Reversible MAOI.

Drug class: All Atypical antipsychotic + Reversible MAOI drugs
Target: All drugs targeting Dopamine D2/D3 receptors; Monoamine oxidase-A
Manufacturer: Beersheva Mental Health Center — full pipeline
Therapeutic area: All drugs in Psychiatry
Indication: Drugs for Schizophrenia with depressive symptoms
Indication: Drugs for Schizoaffective disorder

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