Cobenfy vs Caplyta

both reviewed for schizophrenia - muscarinic agonist vs atypical antipsychotic

Cobenfy(xanomeline and trospium chloride)

Bristol-Myers Squibb Company · 2011 cited findings →

Caplyta(lumateperone)

Johnson & Johnson · 1442 cited findings →

Not a head-to-head comparison. These drugs were studied in separate trials with different designs, populations and timepoints. Each figure below comes from that drug's own reviews and cannot be lined up against the other's.

What the regulatory reviews say

Cobenfy is a muscarinic agonist reviewed for the treatment of schizophrenia in adults. Its FDA review, completed on September 26, 2024, reported a change from baseline in PANSS total score of -21.2 for the KarXT group, compared to -11.6 for the placebo group.

Caplyta is an atypical antipsychotic indicated for depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, both as monotherapy and as adjunctive therapy. Its FDA review noted a MADRS Total Score LS mean difference versus placebo of -4.6. For the 42mg arm, the MADRS Total Score LS mean difference versus placebo was -2.4, and the CGI-BP-S Depression Score p-value was 0.0082.

These drugs were studied in separate trials with different designs, populations, and timepoints. Cobenfy's review focused on schizophrenia symptoms using the PANSS scale, while Caplyta's review addressed bipolar depression symptoms using the MADRS and CGI-BP-S scales. The populations, endpoints, and comparators in their respective trials were distinct. The figures presented are from each drug's own review documents and should not be compared directly, as neither drug is presented as superior to the other.

Each drug's own results — cited

	Cobenfy	Caplyta
Primary Efficacy Measure (Change from Baseline)	-21.2 PANSS total score change from baseline (KarXT) Cobenfy FDA Review, p.53	-4.6 MADRS Total Score LS mean difference vs placebo Caplyta FDA Review, p.48
Comparator Group Efficacy Measure (Change from Baseline)	-11.6 PANSS total score change from baseline (placebo) Cobenfy FDA Review, p.53	-2.4 MADRS Total Score LS mean difference vs placebo (42mg arm) Caplyta FDA Review, p.48

Cobenfy

Caplyta

Primary Efficacy Measure (Change from Baseline)

-21.2

PANSS total score change from baseline (KarXT)

Cobenfy FDA Review, p.53

-4.6

MADRS Total Score LS mean difference vs placebo

Caplyta FDA Review, p.48

Comparator Group Efficacy Measure (Change from Baseline)

-11.6

PANSS total score change from baseline (placebo)

Cobenfy FDA Review, p.53

-2.4

MADRS Total Score LS mean difference vs placebo (42mg arm)

Caplyta FDA Review, p.48

Explore the full evidence

Every cited finding behind both drugs is in the Psychiatry research library →

Figures are as stated in the cited regulatory review documents. Educational reference only — not medical or investment advice.