Loxitane

(Loxapine)

ApprovedSmall molecule

NNew Beta Innovation Limited

Loxitane is one of 125 small molecule programs targeting Neuropathic Pain. It is currently in Approved.

Indications

Total Trials

Active Trials

124

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Neuropathic PainActive, not recruiting

Bipolar I DisorderActive, not recruiting

SchizophreniaActive, not recruiting

Neuropathic PainPhase 2

Active, not recruiting

Bipolar I DisorderPreclinical

Active, not recruiting

SchizophreniaPreclinical

Active, not recruiting

Competition

Competitive Landscape

583 competitors in Schizophrenia

#DrugCompanyPhaseTrials

Loxitane

NNew Beta Innovation Limited

Approved

1 2

Celexa

AbbVie

Preclinical

4 3

Ozempic

Novo Nordisk

Preclinical

1 4

Resotran

Takeda

Preclinical

1 5

Inapsine

Alnylam Pharmaceuticals

Preclinical

1 6

Zocor

OOrganon and Co

Preclinical

6 7

Depakote

Ibrance

Lunesta

3 10

Luvox

SSolvay Pharmaceuticals

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Schizophrenia1 trial

Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)

Completed· Johnson & Johnson logo

Johnson & Johnson··NCT02600741·296 enrolled

Mechanical Ventilation1 trial

Loxapine in the Management of Restlessness During Mechanical Ventilation Weaning

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 4·NCT01193816·100 enrolled

Neuropathic Pain1 trial

Tolerability and Analgesic Efficacy of Loxapine in Patients With Refractory, Chemotherapy-induced Neuropathic Pain

Terminated·UUniversity of Witten/Herdecke·Phase 2·NCT02820519·4 enrolled

Agitation1 trial

Inhaled Loxapine vs Intramuscular (IM) Haloperidol + Lorazepam for Agitation

Terminated·UUniversity of Arkansas·Phase 4·NCT03110900·2 enrolled

Bipolar I Disorder1 trial

Observational Study Evaluating the Safety of ADASUVE® in Agitation Associated With Schizophrenia or Bipolar I Disorder

Suspended·AAlexza Pharmaceuticals, Inc.··NCT03513549·10,000 enrolled

3 more indications

Midazolam1 trial

AGItated Patients Management: intraNASAL Midazolam vs Intramuscular Loxapine

Terminated·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT05324852·1 enrolled

Double-blind1 trial

Randomized Double-blind Trial of Midazolam and Loxapine in Agitated Patients

Terminated·UUniversity Hospital, Rouen·Phase 3·NCT00290082·120 enrolled

Unspecified1 trial

Loxapine and Weaning From Ventilator

Completed·AAssistance Publique - Hôpitaux de Paris·N/A·NCT00122733·9 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

LOXITANE

NDA NDA017525

Jan 1, 1982

LOXITANE C

NDA NDA017658

Jan 1, 1982

LOXITANE IM

NDA NDA018039

Dec 21, 2012

ADASUVE

NDA NDA022549

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for Loxapine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Loxapine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Loxapine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA022549). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Loxitane. U.S. Food & Drug Administration.
[6]
SEC EDGAR — New Beta Innovation Limited company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: NNew Beta Innovation Limited

Patent Landscape[5]

Patent Cliff

Oct 23, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8387612Oct 23, 2026

Loxitane

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Schizophrenia1 trial

Mechanical Ventilation1 trial

Neuropathic Pain1 trial

Agitation1 trial

Bipolar I Disorder1 trial

Midazolam1 trial

Double-blind1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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