Last reviewed 2026-06-01 · How we verify

ITI-007 (Lumateperone)

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

ITI-007 (Lumateperone) is a Serotonin 5-HT7 receptor antagonist / Phosphodiesterase 1 inhibitor Small molecule drug developed by Intra-Cellular Therapies, Inc.. It is currently in Phase 3 development for Schizophrenia (acute and maintenance treatment), Bipolar disorder (in development).

Lumateperone is a serotonin 5-HT7 receptor antagonist and phosphodiesterase 1 inhibitor that modulates intracellular signaling pathways implicated in psychosis and mood disorders.

Lumateperone is a serotonin 5-HT7 receptor antagonist and phosphodiesterase 1 inhibitor that modulates intracellular signaling pathways implicated in psychosis and mood disorders. Used for Schizophrenia (acute and maintenance treatment), Bipolar disorder (in development).

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	ITI-007 (Lumateperone)
Sponsor	Intra-Cellular Therapies, Inc.
Drug class	Serotonin 5-HT7 receptor antagonist / Phosphodiesterase 1 inhibitor
Target	5-HT7 receptor, PDE1
Modality	Small molecule
Therapeutic area	Psychiatry / Neurology
Phase	Phase 3

Mechanism of action

ITI-007 works through a dual mechanism: it antagonizes 5-HT7 receptors and inhibits phosphodiesterase 1 (PDE1), leading to modulation of intracellular cAMP signaling. This mechanism is proposed to address both positive and negative symptoms of schizophrenia while potentially reducing extrapyramidal side effects associated with dopamine antagonism, as it does not directly block dopamine D2 receptors at therapeutic doses.

Approved indications

Schizophrenia (acute and maintenance treatment)
Bipolar disorder (in development)

Common side effects

Somnolence
Nausea
Headache
Dizziness
Akathisia
Weight gain

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:

ITI-007 (Lumateperone) CI brief — competitive landscape report
ITI-007 (Lumateperone) updates RSS · CI watch RSS
Intra-Cellular Therapies, Inc. portfolio CI

Frequently asked questions about ITI-007 (Lumateperone)

What is ITI-007 (Lumateperone)?

ITI-007 (Lumateperone) is a Serotonin 5-HT7 receptor antagonist / Phosphodiesterase 1 inhibitor drug developed by Intra-Cellular Therapies, Inc., indicated for Schizophrenia (acute and maintenance treatment), Bipolar disorder (in development).

How does ITI-007 (Lumateperone) work?

Lumateperone is a serotonin 5-HT7 receptor antagonist and phosphodiesterase 1 inhibitor that modulates intracellular signaling pathways implicated in psychosis and mood disorders.

What is ITI-007 (Lumateperone) used for?

ITI-007 (Lumateperone) is indicated for Schizophrenia (acute and maintenance treatment), Bipolar disorder (in development).

Who makes ITI-007 (Lumateperone)?

ITI-007 (Lumateperone) is developed by Intra-Cellular Therapies, Inc. (see full Intra-Cellular Therapies, Inc. pipeline at /company/intra-cellular-therapies-inc).

What drug class is ITI-007 (Lumateperone) in?

ITI-007 (Lumateperone) belongs to the Serotonin 5-HT7 receptor antagonist / Phosphodiesterase 1 inhibitor class. See all Serotonin 5-HT7 receptor antagonist / Phosphodiesterase 1 inhibitor drugs at /class/serotonin-5-ht7-receptor-antagonist-phosphodiesterase-1-inhibitor.

What development phase is ITI-007 (Lumateperone) in?

ITI-007 (Lumateperone) is in Phase 3.

What are the side effects of ITI-007 (Lumateperone)?

Common side effects of ITI-007 (Lumateperone) include Somnolence, Nausea, Headache, Dizziness, Akathisia, Weight gain.

What does ITI-007 (Lumateperone) target?

ITI-007 (Lumateperone) targets 5-HT7 receptor, PDE1 and is a Serotonin 5-HT7 receptor antagonist / Phosphodiesterase 1 inhibitor.

Drug class: All Serotonin 5-HT7 receptor antagonist / Phosphodiesterase 1 inhibitor drugs
Target: All drugs targeting 5-HT7 receptor, PDE1
Manufacturer: Intra-Cellular Therapies, Inc. — full pipeline
Therapeutic area: All drugs in Psychiatry / Neurology
Indication: Drugs for Schizophrenia (acute and maintenance treatment)
Indication: Drugs for Bipolar disorder (in development)

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