NCT04846868
- Objective
- Not yet disclosed
- Design
- Not yet disclosed
- Participants
- Not yet disclosed
- Primary endpoint
- Not yet disclosed
- Results
- Results not yet reported
pharma · Diabetes Mellitus, Type 2 · Pharmacokinetic trial
Boehringer Ingelheim
Boehringer Ingelheim is a pharma organization headquartered in Ingelheim am Rhein, DE. Primary therapeutic focus areas include Diabetes Mellitus, Type 2, Pharmacokinetic trial, Obesity, Pulmonary Disease, Chronic Obstruc
Binger Straße, Ingelheim am Rhein, Rhineland-Palatinate 55218, DE HQ
46,699 Employees
NMPA registrant Type
Company details
- Status
- Public
- HQ
- Binger Straße, Ingelheim am Rhein, Rhineland-Palatinate 55218, DE
- Employees
- 46,699
- Programs
- 193
- Drugs
- 113
- Patents
- 25
Iclepertin
Phase 3 · small molecule · Schizophrenia
Iclepertin (internal code 1346-0014) is a small-molecule investigational therapeutic developed by Boehringer Ingelheim for schizophrenia. The program is currently in Phase 3 clinical development but has been terminated as of April 8, 2026. The drug was being evaluated in clinical trials registered in the United States
Internal code 1346-0014
At a glance
- Sponsor
- Boehringer Ingelheim
- Phase
- Phase 3
- Modality
- small_molecule
- Indication
- Schizophrenia
- Status
- terminated
- Trials
- 2
Executive summary
Iclepertin (internal code 1346-0014) is a small-molecule investigational therapeutic developed by Boehringer Ingelheim for schizophrenia. The program is currently in Phase 3 clinical development but has been terminated as of April 8, 2026. The drug was being evaluated in clinical trials registered in the United States and China (NCT04846868, NCT05211947). Specific details regarding iclepertin's mechanism of action, molecular target, and route of administration have not been disclosed. The termination of the Phase 3 program represents a significant setback for Boehringer Ingelheim's schizophrenia portfolio, though the rationale for discontinuation has not been publicly disclosed. No regulatory approvals have been granted, and the program is no longer advancing toward market authorization.
Why this program matters
Schizophrenia remains a significant unmet medical need affecting approximately 24 million individuals globally, with existing therapies often limited by efficacy, tolerability, and adherence challenges. The antipsychotic market is dominated by established agents including aripiprazole, paliperidone, and clozapine, yet treatment-resistant cases and adverse effect profiles create persistent demand for novel mechanisms. Iclepertin's development by Boehringer Ingelheim, a major pharmaceutical innovator, suggested potential differentiation in the schizophrenia space. However, the program's termination indicates that clinical or strategic factors prevented advancement. The competitive landscape includes multiple approved small-molecule antipsychotics and emerging therapies, underscoring the high bar for new entrants. The discontinuation removes one potential option from the pipeline but does not materially alter the competitive dynamics of the schizophrenia market, which continues to be served by well-established pharmacological agents and newer formulations targeting improved adherence and safety profiles.
Drug intelligence
Drug Class: Small-molecule antipsychotic (investigational)
Modality: Small molecule
Indication: Schizophrenia
Mechanism of Action: Not yet disclosed
Molecular Target: Not yet disclosed
Route of Administration: Not yet disclosed
Regulatory Status: Clinical trials (terminated Phase 3)
Related Therapies: Competitive small-molecule antipsychotics include aripiprazole, paliperidone ER, clozapine, and iloperidone. Additional agents in the schizophrenia space include ramelteon, vortioxetine, and valbenazine, which address related neuropsychiatric symptoms.
Patent Status: Not yet disclosed
First Approval: Not applicable; program terminated prior to regulatory approval
schizophrenia
Also known as: schizophrenia 12, schizophrenia (disease), SCZD
Overview
A major psychotic disorder characterized by abnormalities in the perception or expression of reality. It affects the cognitive and psychomotor functions. Common clinical signs and symptoms include delusions, hallucinations, disorganized thinking, and retreat from reality.
Treatment landscape
ClinicalTrials.gov lists 2,921 registered studies for Schizophrenia (AACT aggregate).
Phase breakdown: NA (1,441), PHASE4 (414), PHASE3 (377), PHASE2 (297), PHASE1 (276), PHASE1/PHASE2 (52), PHASE2/PHASE3 (42), EARLY_PHASE1 (22)
Common investigational therapies:
- Placebo
- Aripiprazole
- Risperidone
- Olanzapine
- placebo
- risperidone
- Paliperidone ER
- Ziprasidone
- olanzapine
- Quetiapine
Disease data sourced from MONDO Disease Ontology (MONDO:0005090), Orphanet — schizophrenia, NCT00000371, NCT00000372, NCT00000374, NCT00000387, NCT00001192, AACT (ClinicalTrials.gov aggregate), ClinicalTrials.gov, Open Targets Platform (CC BY 4.0).
Clinical development timeline
- Phase 3TBD
Phase 3 ongoing
Iclepertin in Phase 3 clinical development for schizophrenia across multiple trial sites.
- Phase 32026-04-08
Program terminated
Iclepertin Phase 3 development program terminated; rationale not disclosed.
Competitive landscape
Iclepertin entered a mature antipsychotic market dominated by well-established small-molecule agents. Approved competitors include aripiprazole (Otsuka Beijing Research Institute), paliperidone ER (Hospital Authority, Hong Kong), clozapine (Bright Minds Biosciences), and iloperidone (Vanda Pharmaceuticals). Additional approved therapies addressing related symptoms include ramelteon (Takeda), vortioxetine (Takeda), valbenazine (Neurocrine Biosciences), and dexmedetomidine (BioXcel Therapeutics). The competitive set also includes long-acting formulations such as PERSERIS (Indivior) and emerging agents like INTENSIFY SZ (Disc Medicine). The termination of iclepertin's Phase 3 program eliminates a potential new entrant but does not alter the competitive positioning of established antipsychotics, which continue to dominate the schizophrenia treatment landscape through established efficacy, safety profiles, and extensive clinical experience.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| Clozapine | BRIGHT MINDS BIOSCIENCES INC. | small_molecule | approved |
| Iloperidone | Vanda Pharmaceuticals Netherlands B.V. | small_molecule | approved |
| Ramelteon | Takeda | small_molecule | approved |
| PERSERIS | Indivior Pty Ltd | small_molecule | approved |
| INTENSIFY SZ | Disc Medicine | small_molecule | approved |
| Varenicline | BRIGHT MINDS BIOSCIENCES INC. | small_molecule | approved |
| Aripiprazole | Otsuka Beijing Research Institute | small_molecule | approved |
| Paliperidone ER | Hospital Authority, Hong Kong | small_molecule | approved |
| Vortioxetine | Takeda | small_molecule | approved |
| Valbenazine | NEUROCRINE BIOSCIENCES INC | small_molecule | approved |
| Minocycline | BRIGHT MINDS BIOSCIENCES INC. | small_molecule | approved |
| Dexmedetomidine | BioXcel Therapeutics | small_molecule | approved |
| ZIPRASIDONE HYDROCHLORIDE | — | Dopamine D2 receptor antagonist | Approved |
| TRIFLUOPERAZINE HYDROCHLORIDE | — | D2-like dopamine receptor antagonist | Approved |
| THIOTHIXENE | — | Dopamine D2 receptor antagonist | Approved |
| SAMIDORPHAN L-MALATE | — | Delta opioid receptor partial agonist | Approved |
| RISPERIDONE | — | Serotonin 2a (5-HT2a) receptor antagonist | Approved |
| QUETIAPINE FUMARATE | — | Serotonin 2c (5-HT2c) receptor antagonist | Approved |
| PROCHLORPERAZINE | — | Dopamine D2 receptor antagonist | Approved |
| PERPHENAZINE | — | Dopamine D2 receptor antagonist | Approved |
Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.
Regulatory intelligence
United States (FDA): Regulatory status not yet disclosed. Iclepertin was in clinical trial phase; no IND, NDA, or approval status reported.
China (NMPA): Clinical trial registered (NCT05211947) indicating investigational status in China. Specific NMPA approval or filing status not yet disclosed.
Europe (EMA): Regulatory status not yet disclosed.
Japan (PMDA): Regulatory status not yet disclosed.
Program Status: Phase 3 development terminated as of April 8, 2026. No regulatory submissions, approvals, or rejections have been reported. The termination precludes future regulatory advancement unless the program is reinstated.
Clinical evidence summary
NCT05211947
- Objective
- Not yet disclosed
- Design
- Not yet disclosed
- Participants
- Not yet disclosed
- Primary endpoint
- Not yet disclosed
- Results
- Results not yet reported
Key questions answered
What is iclepertin used for?
Iclepertin is an investigational small-molecule therapeutic being developed for the treatment of schizophrenia. The program has been terminated as of April 2026.
Is iclepertin approved by the FDA?
No. Iclepertin has not been approved by the FDA or any other regulatory authority. The Phase 3 development program was terminated in April 2026 prior to regulatory submission.
Who manufactures iclepertin?
Boehringer Ingelheim is the sponsor and developer of iclepertin. No manufacturing or commercialization partner has been disclosed.
What is the mechanism of action of iclepertin?
The mechanism of action of iclepertin has not been disclosed in available sources.
What is the molecular target of iclepertin?
The specific molecular target of iclepertin has not been disclosed.
What is the route of administration for iclepertin?
The route of administration for iclepertin has not been disclosed.
What clinical trials were conducted for iclepertin?
Two clinical trials were registered: NCT04846868 and NCT05211947. Detailed trial designs, objectives, and results have not been disclosed.
What is the current development status of iclepertin?
Iclepertin's Phase 3 development program was terminated on April 8, 2026. The program is no longer advancing.
Why was iclepertin's development terminated?
The rationale for termination of the iclepertin program has not been publicly disclosed by Boehringer Ingelheim.
Does iclepertin have a brand name?
No brand name has been assigned to iclepertin, as the program was terminated prior to regulatory approval.
What are the main competitors to iclepertin?
Approved antipsychotics competing in the schizophrenia market include aripiprazole, paliperidone ER, clozapine, iloperidone, and ramelteon, among others.
Is iclepertin being tested in China?
Yes. Clinical trial NCT05211947 was registered in China, indicating investigational status in that market prior to program termination.
What is the internal code for iclepertin?
The internal code for iclepertin is 1346-0014, assigned by Boehringer Ingelheim.
Does iclepertin have a development partner?
No development or licensing partner has been disclosed for iclepertin. Boehringer Ingelheim is the sole sponsor.
What unmet medical need does iclepertin address?
Iclepertin was intended to address schizophrenia, a condition affecting millions globally with persistent unmet needs for improved efficacy, tolerability, and adherence.
When was iclepertin first disclosed?
The first disclosure date for iclepertin has not been provided in available sources.
Entity relationship graph
Iclepertin → Drug → Target → Indication → Company → Trials → Competitors
Drugs
Companies
Indication
Trials
Analyst insights
Strategic Implications: The termination of iclepertin's Phase 3 program represents a strategic retreat by Boehringer Ingelheim from the schizophrenia indication. Without disclosure of the discontinuation rationale, potential causes include efficacy shortfalls, safety concerns, commercial reassessment, or portfolio prioritization. The decision suggests that iclepertin did not meet the clinical or commercial threshold required for continued investment.
Competitive Implications: The removal of iclepertin from the pipeline does not materially alter competitive dynamics in schizophrenia, as the market remains well-served by established antipsychotics with proven efficacy and safety. The termination may reflect the high regulatory and commercial bar for new antipsychotics in a market where generic and biosimilar competition is intense.
Future Catalysts: No further clinical milestones are expected for iclepertin unless Boehringer Ingelheim announces program reinstatement. The lack of disclosed rationale for termination limits ability to assess whether the decision reflects program-specific issues or broader strategic shifts in the sponsor's neuroscience portfolio.
Expected Milestones: None anticipated; program terminated.
Quick answers
Concise, citable answers optimized for AI answer engines.
- What is iclepertin?
- Investigational small-molecule antipsychotic developed by Boehringer Ingelheim for schizophrenia.
- Is iclepertin approved?
- No; Phase 3 program terminated April 2026 prior to regulatory approval.
- Who makes iclepertin?
- Boehringer Ingelheim.
- What is iclepertin's indication?
- Schizophrenia.
- What is iclepertin's mechanism of action?
- Not yet disclosed.
- What is iclepertin's molecular target?
- Not yet disclosed.
- What is iclepertin's route of administration?
- Not yet disclosed.
- What is iclepertin's current development phase?
- Terminated; was in Phase 3.
- What is iclepertin's internal code?
- 1346-0014.
- Does iclepertin have a development partner?
- No partner disclosed; Boehringer Ingelheim is sole sponsor.
- What clinical trials tested iclepertin?
- NCT04846868 and NCT05211947; details not disclosed.
- Why was iclepertin terminated?
- Rationale not publicly disclosed by Boehringer Ingelheim.
- When was iclepertin terminated?
- April 8, 2026.
- What competitors does iclepertin face?
- Aripiprazole, paliperidone ER, clozapine, iloperidone, ramelteon, vortioxetine, valbenazine.
- Is iclepertin in clinical trials in China?
- Was; trial NCT05211947 registered in China prior to program termination.
- What is iclepertin's brand name?
- No brand name assigned; program terminated pre-approval.
- What is iclepertin's modality?
- Small molecule.
- What is the unmet need for iclepertin?
- Schizophrenia treatment with improved efficacy, tolerability, and adherence.
- Is iclepertin approved in Europe?
- No; program terminated prior to EMA submission or approval.
- Is iclepertin approved in Japan?
- No; program terminated prior to PMDA submission or approval.
- What is iclepertin's patent status?
- Not yet disclosed.
- When was iclepertin first disclosed?
- First disclosure date not yet disclosed.
- Does iclepertin have a lead investigator?
- Lead investigator not yet disclosed.
- What is iclepertin's projected peak sales?
- Not yet disclosed; program terminated.
Evidence & sources
- ClinicalTrials.gov NCT04846868 (clinicaltrials)
- ClinicalTrials.gov NCT05211947 (clinicaltrials)
- Source: phase (source_attribution)
- MONDO Disease Ontology (MONDO:0005090) (mondo)
- Orphanet — schizophrenia (orphanet)
- NCT00000371 (clinicaltrials_gov)
- NCT00000372 (clinicaltrials_gov)
- NCT00000374 (clinicaltrials_gov)
- NCT00000387 (clinicaltrials_gov)
- NCT00001192 (clinicaltrials_gov)
- AACT (ClinicalTrials.gov aggregate) (aact)
- ClinicalTrials.gov (clinicaltrials_gov)
- Open Targets Platform (opentargets)
Intelligence compiled from public regulatory and clinical sources (FDA, EMA, ClinicalTrials.gov and company disclosures). Figures may be editorial or analyst estimates; verify against primary sources before relying on them.