Last reviewed 2026-05-22 · How we verify

Lumateperone low dose

Intra-Cellular Therapies, Inc. · Phase 3 active Small molecule Under review

Lumateperone low dose is a Serotonin-dopamine antagonist Small molecule drug developed by Intra-Cellular Therapies, Inc.. It is currently in Phase 3 development for Schizophrenia.

Lumateperone is a serotonin-dopamine antagonist that modulates glutamatergic neurotransmission.

Lumateperone is a small molecule serotonin 2a (5-HT2a) receptor antagonist, classified as an antagonist. It is being studied as a potential treatment for schizophrenia and irritability associated with autism spectrum disorder.

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	Lumateperone low dose
Sponsor	Intra-Cellular Therapies, Inc.
Drug class	Serotonin-dopamine antagonist
Target	5-HT2A receptor, D2 receptor
Modality	Small molecule
Therapeutic area	Psychiatry
Phase	Phase 3

Mechanism of action

Lumateperone acts as a partial agonist at the serotonin 5-HT2A receptor and a dopamine D2 receptor antagonist. This mechanism of action is thought to contribute to its therapeutic effects in treating schizophrenia. Additionally, lumateperone has been shown to modulate glutamatergic neurotransmission, which may also play a role in its therapeutic effects.

Approved indications

Schizophrenia

Common side effects

Orthostatic hypotension
Weight gain
Dizziness
Headache
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:

Lumateperone low dose CI brief — competitive landscape report
Lumateperone low dose updates RSS · CI watch RSS
Intra-Cellular Therapies, Inc. portfolio CI

Frequently asked questions about Lumateperone low dose

What is Lumateperone low dose?

Lumateperone low dose is a Serotonin-dopamine antagonist drug developed by Intra-Cellular Therapies, Inc., indicated for Schizophrenia.

How does Lumateperone low dose work?

Lumateperone is a serotonin-dopamine antagonist that modulates glutamatergic neurotransmission.

What is Lumateperone low dose used for?

Lumateperone low dose is indicated for Schizophrenia.

Who makes Lumateperone low dose?

Lumateperone low dose is developed by Intra-Cellular Therapies, Inc. (see full Intra-Cellular Therapies, Inc. pipeline at /company/intra-cellular-therapies-inc).

What drug class is Lumateperone low dose in?

Lumateperone low dose belongs to the Serotonin-dopamine antagonist class. See all Serotonin-dopamine antagonist drugs at /class/serotonin-dopamine-antagonist.

What development phase is Lumateperone low dose in?

Lumateperone low dose is in Phase 3.

What are the side effects of Lumateperone low dose?

Common side effects of Lumateperone low dose include Orthostatic hypotension, Weight gain, Dizziness, Headache, Nausea.

What does Lumateperone low dose target?

Lumateperone low dose targets 5-HT2A receptor, D2 receptor and is a Serotonin-dopamine antagonist.

Drug class: All Serotonin-dopamine antagonist drugs
Target: All drugs targeting 5-HT2A receptor, D2 receptor
Manufacturer: Intra-Cellular Therapies, Inc. — full pipeline
Therapeutic area: All drugs in Psychiatry
Indication: Drugs for Schizophrenia

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