1. Scrip
  2. >>R&D
  3. >>Clinical Trials

First Phase III Depression Data For Intra-Cellular’s Caplyta Exceed Expectations

Add-On To Schizophrenia, Bipolar Depression Indications

 
• By Mandy Jackson

With positive results from the first Phase III trial of lumateperone in major depressive disorder and a second readout expected later this quarter, the company plans a supplemental filing in late 2024.

Depiction of fear, loneliness, depression, abuse, addiction
Lumateperone met the primary and secondary endpoints in MDD • Source: Shutterstock

Intra-Cellular Therapies, Inc. reported positive results on 16 April from the first Phase III clinical trial of Caplyta (lumateperone) in major depressive disorder (MDD) that exceeded expectations for the study and increased speculation that the drug would add to the drug’s blockbuster potential. Assuming a second Phase III trial in MDD is positive when it reads out late in the second quarter of 2024, the company plans to file for supplemental approval in the third indication later this year.

Key Takeaways

  • Intra-Cellular Therapies reported positive results from the first Phase III study of Caplyta (lumateperone) as an adjunct to antidepressant therapies in major depressive disorder (MDD).

The US Food and Drug Administration approved the atypical antipsychotic Caplyta for adults with schizophrenia in December 2019 and as...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Clinical Trials

MBX Surges As Phase II Data Show Competitive Profile For Canvuparatide

 
• By Mandy Jackson

MBX Biosciences reported Phase II results for once-weekly canvuparatide that showed comparable efficacy to Ascendis Pharma’s once-daily Yorvipath for hypoparathyroidism.

Ionis Targets Ultra-Rare Disease Market With Zilganersen

 
• By Alaric DeArment

The biotech announced positive topline results from its pivotal study in Alexander disease, which has an estimated population of about 300 in the US.

EADV: UCB’s Bimzelx Primed To Maintain Pole Position in HS

 
• By Kevin Grogan

The Belgium-based group has collected heaps of long-term efficacy and safety data which will help stave off the competition.

Roche’s evERA Giredestrant Study Hits In All-Comer Breast Cancer Population

 
• By Alexandra Shimmings

The Phase III trial of the SERD has shown a significant benefit in the intent-to-treat and ESR1-mutated populations in post-CDK ER+/HER2- metastatic breast cancer but whether the data will be enough to support an equally broad approval remains to be seen.

More from R&D

Roche’s evERA Giredestrant Study Hits In All-Comer Breast Cancer Population

 
• By Alexandra Shimmings

The Phase III trial of the SERD has shown a significant benefit in the intent-to-treat and ESR1-mutated populations in post-CDK ER+/HER2- metastatic breast cancer but whether the data will be enough to support an equally broad approval remains to be seen.

Pipeline Watch: Six Approvals And Twenty Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

QL Biopharm’s Zovaglutide Offers Potentially Safer Once-Monthly Obesity Option

 
• By Dexter Jie Yan

Zovaglutide tied Amgen’s MariTide in weight reduction at Week 24 in a Phase II study, but with a potentially better safety profile. However, efficacy versus existing once-weekly drugs is a remaining question.