Last reviewed 2026-05-25 · How we verify

Lurasidone HC1

Sumitomo Pharma America, Inc. · Phase 3 active Small molecule ✓ Verified May 2026

Lurasidone HC1 is a Atypical antipsychotic Small molecule drug developed by Sumitomo Pharma America, Inc.. It is currently in Phase 3 development for Schizophrenia, Bipolar I disorder depression, Major depressive disorder (adjunctive treatment).

Lurasidone is an atypical antipsychotic that blocks dopamine D2 and serotonin 5-HT7 receptors in the brain.

Lurasidone HC1 is used to treat chronic schizophrenia. It is compared to Quetiapine XR in clinical trials for this indication.

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	Lurasidone HC1
Sponsor	Sumitomo Pharma America, Inc.
Drug class	Atypical antipsychotic
Target	Dopamine D2 receptor, Serotonin 5-HT7 receptor
Modality	Small molecule
Therapeutic area	Psychiatry
Phase	Phase 3

Mechanism of action

Lurasidone acts as an antagonist at dopamine D2 receptors and serotonin 5-HT7 receptors, with high binding affinity and selectivity for these targets. This dual antagonism helps modulate neurotransmitter activity implicated in psychotic and mood disorders. The drug has minimal affinity for other receptors, which may contribute to a favorable side-effect profile compared to first-generation antipsychotics.

Approved indications

Schizophrenia
Bipolar I disorder depression
Major depressive disorder (adjunctive treatment)

Common side effects

Akathisia
Somnolence
Parkinsonism
Nausea
Agitation
Headache

Key clinical trials

Lurasidone HCl - A Long Term Phase 3 Study of Patients With Chronic Schizophrenia (PHASE3)

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:

Lurasidone HC1 CI brief — competitive landscape report
Lurasidone HC1 updates RSS · CI watch RSS
Sumitomo Pharma America, Inc. portfolio CI

Frequently asked questions about Lurasidone HC1

What is Lurasidone HC1?

Lurasidone HC1 is a Atypical antipsychotic drug developed by Sumitomo Pharma America, Inc., indicated for Schizophrenia, Bipolar I disorder depression, Major depressive disorder (adjunctive treatment).

How does Lurasidone HC1 work?

Lurasidone is an atypical antipsychotic that blocks dopamine D2 and serotonin 5-HT7 receptors in the brain.

What is Lurasidone HC1 used for?

Lurasidone HC1 is indicated for Schizophrenia, Bipolar I disorder depression, Major depressive disorder (adjunctive treatment).

Who makes Lurasidone HC1?

Lurasidone HC1 is developed by Sumitomo Pharma America, Inc. (see full Sumitomo Pharma America, Inc. pipeline at /company/sumitomo-pharma-america-inc).

What drug class is Lurasidone HC1 in?

Lurasidone HC1 belongs to the Atypical antipsychotic class. See all Atypical antipsychotic drugs at /class/atypical-antipsychotic.

What development phase is Lurasidone HC1 in?

Lurasidone HC1 is in Phase 3.

What are the side effects of Lurasidone HC1?

Common side effects of Lurasidone HC1 include Akathisia, Somnolence, Parkinsonism, Nausea, Agitation, Headache.

What does Lurasidone HC1 target?

Lurasidone HC1 targets Dopamine D2 receptor, Serotonin 5-HT7 receptor and is a Atypical antipsychotic.

Drug class: All Atypical antipsychotic drugs
Target: All drugs targeting Dopamine D2 receptor, Serotonin 5-HT7 receptor
Manufacturer: Sumitomo Pharma America, Inc. — full pipeline
Therapeutic area: All drugs in Psychiatry
Indication: Drugs for Schizophrenia
Indication: Drugs for Bipolar I disorder depression
Indication: Drugs for Major depressive disorder (adjunctive treatment)

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