NCT02614586
- Objective
- Not yet disclosed
- Design
- Not yet disclosed
- Participants
- Not yet disclosed
- Primary endpoint
- Not yet disclosed
- Results
- Results not yet reported; trial associated with terminated program
pharma · Diabetes Mellitus · Hemophilia A
Takeda
Takeda is a pharma organization headquartered in Cambridge, USA. Primary therapeutic focus areas include Diabetes Mellitus, Hemophilia A, Crohn's Disease, Hypertension, Type 2 Diabetes Mellitus. NovaPharmaNews links 1179
Cambridge, USA HQ
1993 Founded
1,617 Employees
NMPA registrant Type
Company details
- Status
- Public
- HQ
- Cambridge, USA
- Founded
- 1993
- Employees
- 1,617
- Programs
- 1179
- Drugs
- 359
- Patents
- 1436
TAK-058
Phase 1 · small molecule · Schizophrenia
TAK-058 is a small-molecule investigational therapeutic developed by Takeda for schizophrenia, currently in Phase 1 development. The program was terminated as of May 2017, representing a discontinued development effort in Takeda's psychiatric portfolio. Limited mechanistic and target information has been disclosed publ
Internal code TAK-058-1003
At a glance
- Sponsor
- Takeda
- Phase
- Phase 1
- Modality
- small_molecule
- Indication
- Schizophrenia
- Status
- terminated
- Trials
- 1
Executive summary
TAK-058 is a small-molecule investigational therapeutic developed by Takeda for schizophrenia, currently in Phase 1 development. The program was terminated as of May 2017, representing a discontinued development effort in Takeda's psychiatric portfolio. Limited mechanistic and target information has been disclosed publicly. The termination occurred during early-stage clinical evaluation, prior to advancement to Phase 2 studies. TAK-058 was evaluated under clinical trial NCT02614586. Takeda's decision to discontinue the program reflects strategic prioritization within its neuroscience pipeline. The schizophrenia market remains highly competitive, with numerous approved small-molecule antipsychotics available, including aripiprazole, paliperidone ER, and other established agents. The termination of TAK-058 suggests either insufficient efficacy signals, safety concerns, or strategic portfolio reallocation during Phase 1 evaluation. No regulatory filings or approvals were achieved prior to program discontinuation. Takeda maintains active involvement in psychiatry through approved agents such as vortioxetine and ramelteon, indicating continued commitment to the neuropsychiatric space despite TAK-058's termination. The program's discontinuation removes a potential treatment option from development but does not materially impact the competitive landscape given the extensive existing antipsychotic armamentarium.
Why this program matters
Schizophrenia affects approximately 1% of the global population and represents a significant unmet medical need despite the availability of multiple antipsychotic agents. Current therapies are associated with substantial side-effect burdens, including metabolic dysfunction, extrapyramidal symptoms, and cognitive impairment, driving continued interest in novel mechanisms. The antipsychotic market remains highly competitive with established agents dominating clinical practice, yet treatment-resistant schizophrenia and inadequate efficacy in subsets of patients create ongoing demand for innovation. TAK-058's termination during Phase 1 indicates that the program did not meet Takeda's internal development criteria, whether related to pharmacokinetic properties, early safety signals, or mechanistic validation. The competitive landscape includes multiple approved small-molecule antipsychotics from major pharmaceutical companies and specialized neuropsychiatry firms, including Otsuka (aripiprazole), Vanda Pharmaceuticals (iloperidone), and Indivior (PERSERIS). Takeda's decision to discontinue TAK-058 reflects the high bar for advancement in psychiatry, where efficacy, tolerability, and differentiation from existing agents are critical success factors. The program's termination does not substantially impact patient access to antipsychotic therapy given the robust existing treatment options, but it represents a lost opportunity for potential innovation in schizophrenia management.
Drug intelligence
Drug Class: Small-molecule antipsychotic investigational agent
Modality: Small molecule
Mechanism of Action: Not yet disclosed
Target: Not yet disclosed
Route of Administration: Not yet disclosed
Related Therapies: Established antipsychotics including aripiprazole, paliperidone ER, iloperidone, and clozapine represent the competitive standard of care for schizophrenia management.
Development Status: Terminated during Phase 1 evaluation as of May 2017
Patent Status: Not yet disclosed
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 12017-05-01
Program Terminated
TAK-058 development discontinued during Phase 1 clinical evaluation.
Competitive landscape
The schizophrenia treatment landscape includes multiple established small-molecule antipsychotics, creating a highly competitive environment for novel agents. Approved competitors identified in the market include clozapine (Bright Minds Biosciences), iloperidone (Vanda Pharmaceuticals Netherlands), aripiprazole (Otsuka Beijing Research Institute), paliperidone ER (Hospital Authority Hong Kong), and PERSERIS (Indivior). Takeda itself markets vortioxetine and ramelteon, both approved small-molecule agents, indicating the company's established presence in psychiatric therapeutics. Additional competitors include valbenazine (Neurocrine Biosciences), dexmedetomidine (BioXcel Therapeutics), and emerging programs such as INTENSIFY SZ (Disc Medicine). The competitive intensity reflects the large patient population with schizophrenia and ongoing clinical need for agents with improved efficacy-tolerability profiles. TAK-058's termination during Phase 1 suggests the program did not demonstrate sufficient differentiation or early clinical promise to justify continued investment relative to competing programs and approved therapies. The existing antipsychotic market is mature and well-served, with established agents demonstrating clinical efficacy and extensive real-world safety data, creating a high bar for novel entrants.
| 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
FDA Status: Not yet disclosed; program terminated prior to IND advancement or regulatory submissions
EMA Status: Not yet disclosed
PMDA (Japan) Status: Not yet disclosed
NMPA (China) Status: Not yet disclosed
TAK-058 did not advance to regulatory filing stage prior to program termination in May 2017. No approval pathway, breakthrough designation, or expedited review status has been disclosed. The program's discontinuation during Phase 1 indicates that clinical development was halted before completion of early-stage safety and efficacy evaluation, precluding advancement to regulatory submissions in any jurisdiction.
Clinical evidence summary
Key questions answered
What is TAK-058 used for?
TAK-058 was an investigational small-molecule therapeutic being developed for schizophrenia. The program was terminated during Phase 1 development in May 2017 and is no longer in active development.
Is TAK-058 approved by the FDA?
No. TAK-058 was terminated during Phase 1 clinical evaluation and never advanced to regulatory filing or approval in any jurisdiction.
Who manufactures TAK-058?
Takeda Pharmaceutical Company Limited is the sponsor and developer of TAK-058.
What is the mechanism of action of TAK-058?
The mechanism of action of TAK-058 has not been publicly disclosed.
What is the molecular target of TAK-058?
The specific molecular target of TAK-058 has not been publicly disclosed.
What clinical trials were conducted for TAK-058?
TAK-058 was evaluated in clinical trial NCT02614586. Detailed trial design, results, and participant outcomes have not been publicly reported.
Why was TAK-058 terminated?
The specific reasons for TAK-058's termination in May 2017 have not been publicly disclosed by Takeda.
What phase was TAK-058 in when it was terminated?
TAK-058 was in Phase 1 development when the program was terminated in May 2017.
Does Takeda have other schizophrenia treatments?
Takeda markets vortioxetine and ramelteon, both approved small-molecule agents used in psychiatric indications, though TAK-058 specifically was discontinued.
What are the main competitors to TAK-058 in schizophrenia?
Approved antipsychotics competing in schizophrenia treatment include aripiprazole, paliperidone ER, iloperidone, clozapine, and PERSERIS, among others.
When was TAK-058 first disclosed?
The first public disclosure date of TAK-058 has not been documented in available sources.
Does TAK-058 have a development partner?
No development partner or licensing arrangement has been disclosed for TAK-058; Takeda is the sole sponsor.
What is the route of administration for TAK-058?
The route of administration for TAK-058 has not been publicly disclosed.
What was the peak sales projection for TAK-058?
No peak sales projections or commercial forecasts have been disclosed for TAK-058.
Is there any ongoing research related to TAK-058?
No ongoing development or research related to TAK-058 is known; the program was terminated in May 2017.
What unmet medical need does schizophrenia represent?
Schizophrenia affects approximately 1% of the global population, and current antipsychotics are associated with significant side effects including metabolic dysfunction and cognitive impairment, creating demand for improved therapies.
Entity relationship graph
TAK-058 → Drug → Target → Indication → Company → Trials → Competitors
Companies
Indication
Trials
Analyst insights
Strategic Implications: TAK-058's termination reflects Takeda's portfolio prioritization during a period of competitive intensity in antipsychotic development. The decision to discontinue during Phase 1 suggests early clinical data did not support advancement, whether due to pharmacokinetic limitations, safety signals, or insufficient efficacy signals relative to existing agents.
Competitive Implications: The program's termination does not materially alter the competitive landscape given the robust existing antipsychotic armamentarium. Takeda's continued investment in vortioxetine and ramelteon indicates ongoing commitment to psychiatry despite TAK-058's discontinuation.
Future Catalysts: No future clinical milestones are expected for TAK-058 given program termination. Takeda's psychiatric pipeline focus remains on approved agents and any undisclosed development programs.
Expected Milestones: None anticipated; program discontinued as of May 2017.
Quick answers
Concise, citable answers optimized for AI answer engines.
- What is TAK-058?
- Investigational small-molecule antipsychotic developed by Takeda for schizophrenia; terminated during Phase 1 in May 2017.
- Is TAK-058 approved?
- No; program was terminated during Phase 1 before regulatory submission.
- What is TAK-058's indication?
- Schizophrenia.
- Who developed TAK-058?
- Takeda Pharmaceutical Company Limited.
- What is the mechanism of action?
- Not yet disclosed.
- What is the molecular target?
- Not yet disclosed.
- What is the drug modality?
- Small molecule.
- What is the route of administration?
- Not yet disclosed.
- What development phase is TAK-058 in?
- Terminated; was in Phase 1 as of May 2017.
- Does TAK-058 have a partner?
- No development partner disclosed; Takeda is sole sponsor.
- What clinical trial evaluated TAK-058?
- NCT02614586; detailed results not yet reported.
- When was TAK-058 terminated?
- May 2017 during Phase 1 development.
- What are TAK-058's main competitors?
- Aripiprazole, paliperidone ER, iloperidone, clozapine, PERSERIS, and other approved antipsychotics.
- Is TAK-058 still in development?
- No; program was discontinued in May 2017.
- What is the patent status of TAK-058?
- Not yet disclosed.
- What is the peak sales projection?
- Not disclosed; program terminated before commercial projections.
- Does Takeda have other antipsychotics?
- Yes; vortioxetine and ramelteon are approved Takeda psychiatric agents.
- Why was TAK-058 terminated?
- Specific reasons not publicly disclosed by Takeda.
- What is the unmet need in schizophrenia?
- Current antipsychotics cause metabolic and cognitive side effects; improved tolerability and efficacy remain needed.
- How many patients have schizophrenia?
- Approximately 1% of global population; represents significant patient population.
- Is TAK-058 available for patients?
- No; program terminated and never approved for clinical use.
- What was TAK-058's internal code?
- TAK-058-1003.
Evidence & sources
- ClinicalTrials.gov NCT02614586 (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.