Boehringer Ingelheim’s Iclepertin Fails to Meet Primary and Secondary Endpoints in Phase III Schizophrenia Trials

Trial Failure:
Boehringer Ingelheim's Phase III CONNEX clinical trial program for iclepertin, aimed at treating cognitive impairment in adults with schizophrenia, failed to meet its primary and key secondary endpoints134.

Safety Profile:
Despite the efficacy failure, iclepertin showed a favorable safety profile consistent with previous studies13.

Program Discontinuation:
The company has decided to discontinue the long-term extension trial, CONNEX-X, effective immediately35.

Future Research:
Boehringer Ingelheim remains committed to finding effective solutions for serious mental illnesses, with over 20 additional investigative therapies in development for schizophrenia and major depressive disorder135.

Market Context:
The global market for drugs targeting cognitive impairment in schizophrenia is expected to grow significantly, from an estimated $25m by the end of 2025 to $429m by the end of 20301.

Unmet Need:
There are no approved targeted pharmaceutical treatments for cognitive impairment in schizophrenia, which affects approximately 24 million people worldwide and is a leading cause of disability and impairment in daily functioning3.

Sources:

1. https://www.clinicaltrialsarena.com/news/boehringer-ingelheim-announces-phase-iii-schizophrenia-failures/

3. https://www.globenewswire.com/news-release/2025/01/16/3010915/0/en/Boehringer-provides-update-on-iclepertin-Phase-III-program-in-schizophrenia.html

4. https://www.thepharmaletter.com/boehringers-iclepertin-phase-3-program-in-schizophrenia-misses-goals

5. https://www.biospace.com/drug-development/boehringer-suffers-phase-iii-schizophrenia-fail-legal-parry-by-hhs