Nxera Regains Full Rights To GPR52 Schizophrenia Program After Boehringer Ingelheim Declines Option; Nxera To Seek New Partner For Phase 2–Ready GPR52 Agonist

Nxera Pharma Co. Ltd. announced that Boehringer Ingelheim has decided not to exercise its exclusive option to license Nxera’s GPR52 agonist program for schizophrenia, including the Phase 2–ready lead candidate NXE0048149 (NXE’149). As a result, all rights to the GPR52 portfolio fully revert to Nxera, together with all data and intellectual property generated under the collaboration, in accordance with the terms of the Collaboration and License Option Agreement.

NXE’149 and related GPR52 agonists were designed using Nxera’s proprietary NxWave™ structure-based drug design platform and are intended to address the positive, negative, and cognitive symptoms of schizophrenia, a key limitation of currently available therapies.

A completed Phase 1 clinical trial evaluating single and multiple ascending doses of NXE’149 demonstrated a favorable safety and tolerability profile in healthy participants. The compound was well tolerated across all dose levels, with no severe or serious adverse events and no treatment discontinuations. Pharmacokinetic analyses showed dose-proportional exposure, equivalent free drug concentrations in plasma and cerebrospinal fluid at steady state, and a long half-life supportive of once-daily dosing.

Christopher Cargill, CEO and President of Nxera Pharma, commented: “Although we are disappointed that Boehringer Ingelheim has chosen not to proceed with the license option, its decision does not diminish the significant potential of the GPR52 agonist program, which has demonstrated highly encouraging attributes as a first-in-class approach to treating several major symptoms of schizophrenia and address the shortcomings of current treatment options. “We are energised by the strong scientific and clinical foundations already established and see meaningful 2 of 2 opportunity in regaining full rights. We look forward to updating the market as we advance discussions with potential partners next year.”

Importantly, pharmacodynamic assessments, including cognitive testing, neurophysiological measures, and peripheral biomarkers, provided evidence of engagement of brain circuitry relevant to schizophrenia and related neuropsychiatric disorders. GPR52 is expressed in brain regions associated with positive symptoms such as hallucinations and delusions, as well as cognitive dysfunction and negative symptoms, including attention deficits, social withdrawal, and apathy. These findings suggest that NXE’149 may have the potential to address all three symptom domains of schizophrenia, differentiating it from current antipsychotic therapies that primarily target positive symptoms.

With the GPR52 program now Phase 2 ready, Nxera plans to pursue strategic options, including a formal out-licensing process, with the goal of partnering the program with a major pharmaceutical or specialist neuroscience company in 2026. The company stated that this development does not impact Nxera’s consolidated financial results for the current accounting period.