• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • Patient Education
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Latuda (lurasidone)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Latuda (lurasidone)

  • Profile

Profile

Contact Information

Currently Enrolling Trials

    Show More

    General Information

    Latuda (lurasidone) is a psychotropic agent belonging to the chemical class of benzoisothiazol derivatives. The mechanism of action of lurasidone is unknown, however has been suggested that the efficacy of lurasidone in schizophrenia is mediated through a combination of central dopamine Type 2 (D ) and serotonin Type 2 (5HT2A) receptor antagonism.

    Latuda is specifically indicated for the treatment of patients with schizophrenia.

    Latuda is supplied as a tablet for oral administration. The recommended starting dose is 40 mg once daily and the maximum recommended dose is 80 mg/day. Latuda should be taken with food (at least 350 calories). Dose adjustments are recommended for the following: patients with moderate and severe renal impairment, patients with moderate and severe hepatic impairment, patients taking concomitant potential CYP3A4 inhibitors and patients taking concomitant potential CYP3A4 inducers.

    Clinical Results

    FDA Approval
    The FDA approval of Latudat was based on four short-term (6-week), placebo-controlled studies in adult patients (mean age of 38.8 years) who met DSM-IV crit eria for schizophrenia. Efficacy was based on the Positive and Negative Syndrome Scale (PANSS), the Brief Psychiatric Rating Scale derived (BPRSd), derived from the PANSS and the Clinical Global Impression severity scale (CGI-S). The endpoint was a comparision of the change from baseline in the total score to the end of week 6 between Latuda, placebo and control groups. The results are as follows:
    Study One
    This trial enrolled 145 subjects and compared two fixed doses of Latuda (40 or 120 mg/day) to placebo. Both doses of Latuda were superior to placebo on the BPRSd total score, and the CGI-S.
    Study Two
    This study enrolled 180 subjects and compared a fixed dose of Latuda (80 mg/day) to placebo. Latuda was superior to placebo on the BPRSd total score, and the CGI-S.
    Study Three
    This placebo and active-controlled trial enrolled 473 subjects and compared two fixed doses of Latuda (40 or 120 mg/day) and an active control (olanzapine) to placebo. Both Latuda doses and the active control were superior to placebo on the PANSS total score, and the CGI-S.
    Study Four
    This trial enrolled 489 subjects and compared three fixed doses of Latuda (40, 80 or 120 mg/day) to placebo. Only the 80 mg/day dose of Latuda was superior to placebo on the PANSS total score, and the CGI-S.

    The efficacy of Latuda at doses of 40, 80 and 120 mg/day was established in two studies for each dose. However, the 120 mg dose did not appear to add additional benefit over the 40 mg dose.

    Side Effects

    Adverse events associated with the use of Latuda may include, but are not limited to, the following:

    • Somnolence
    • Akathisia
    • Nausea
    • Parkinsonism
    • Agitation

    Mechanism of Action

    Latuda (lurasidone) is a psychotropic agent belonging to the chemical class of benzoisothiazol derivatives. The mechanism of action of lurasidone is unknown, however has been suggested that the efficacy of lurasidone in schizophrenia is mediated through a combination of central dopamine Type 2 (D ) and serotonin Type 2 (5HT2A) receptor antagonism.

    Literature References

    Ishibashi T, Horisawa T, Tokuda K, Ishiyama T, Ogasa M, Tagashira R, Matsumoto K, Nishikawa H, Ueda Y, Toma S, Oki H, Tanno N, Saji I, Ito A, Ohno Y, Nakamura M Pharmacological profile of lurasidone, a novel antipsychotic agent with potent 5-hydroxytryptamine 7 (5-HT7) and 5-HT1A receptor activity. The Journal of pharmacology and experimental therapeutics 2010 Jul;334(1):171-81

    Nakamura M, Ogasa M, Guarino J, Phillips D, Severs J, Cucchiaro J, Loebel A Lurasidone in the treatment of acute schizophrenia: a double-blind, placebo-controlled trial. The Journal of clinical psychiatry 2009 Jun;70(6):829-36

    Additional Information

    For additional information regarding Latuda or schizophrenia, please visit the Latuda web page.

    Approval Date: 2010-10-01
    Company Name: Sunovion
    Back to Listings

    Upcoming Events

    • 26Jan

      Reducing Complexity in Starting Clinical Trials – More Patients, Faster Startup

    • 27Jan

      Medical Device Clinical Trials in China: Latest Regulatory Developments

    • 11Feb

      Lab X.0: Addressing Quality and Compliance Challenges in Laboratory Operations in the COVID-19 All-Digital Era

    • 23Mar

      Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

    • 26Apr

      MAGI's Clinical Research vConference — Spring 2021

    Featured Products

    • Regenerative Medicine – Steps to Accelerate Development : PDF

      Regenerative Medicine: Steps to Accelerate Development

    • Clinical Trial Agreements — A Guide to Key Words and Phrases : PDF

      Clinical Trial Agreements: A Guide to Key Words and Phrases

    Featured Stories

    • TechInnovation-360x240.png

      Pace of Technology Innovation in Trials Could Slow After Pandemic Eases

    • AskTheExperts-360x240.png

      Ask the Experts: Certifying and Maintaining Copies of Original Source Documents

    • Resources-360x240.png

      Trial Complexity, Endpoints Continue to Increase, Stretching Site Resources

    • FocusinRed-360x240.png

      Return to Focus on Risk Management Postpandemic Could Prove Challenging to Sites

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell My Personal Information

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing