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talnetant

Phase 2

Irritable Colon | Small molecule | Gastrointestinal |GSK plc|Last Updated: Aug 16, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment741

FDA Designations

No designations recorded

Clinical trial landscape

talnetant · 4 trials · 2 indications

Phase 2 4
NCT00103727Study Of Talnetant Versus Placebo And Risperidone In SchizophreniaSchizophrenia
COMPLETED282 Analytics
NCT00300963Effect Of Talnetant Versus Risperidone Versus Placebo On Psychotic Symptoms In Schizophrenic PatientsSchizophrenia
COMPLETED275 Analytics
NCT00101985Eight-Weeks Of Treatment With Talnetant In Subjects With Irritable Bowel Syndrome (IBS)Irritable Colon
COMPLETED741 Analytics
NCT00049946Schizophrenia Study In AdultsSchizophrenia
COMPLETED231 Analytics
PHASE2COMPLETED
Study Of Talnetant Versus Placebo And Risperidone In Schizophrenia
SchizophreniaUnlock trial analytics
PHASE2COMPLETED
Effect Of Talnetant Versus Risperidone Versus Placebo On Psychotic Symptoms In Schizophrenic Patients
SchizophreniaUnlock trial analytics
PHASE2COMPLETED
Eight-Weeks Of Treatment With Talnetant In Subjects With Irritable Bowel Syndrome (IBS)
Irritable ColonUnlock trial analytics
PHASE2COMPLETED
Schizophrenia Study In Adults
SchizophreniaUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary outcome measure is change in the Positive and Negative Syndrome Scale (PANSS) at Week 6 compared to baseline values.
6 weeks
Determine whether talnetant provided adequate relief from IBS pain and discomfort for at least one of three talnetant dose groups compared with placebo and to determine the safety and tolerability of talnetant in subjects with IBS.
Change from baseline in the PANSS total score.

Secondary Endpoints

The secondary measures assess both efficacy (cognition, depression) as well as a variety of safety/tolerability endpoints (adverse events, motor function, laboratory measures).
6 weeks
- Explore response among subgroups IBS. - Evaluate positive treatment effects within bowel subgroups. - Compare treatment groups for global improvement of IBS symptoms. - Improvement of IBS pain or discomfort, Quality of Life.
Secondary measures assessed efficacy, safety & tolerability endpoints using the PANSS, BPRS Psychosis score, CGI-S, CGI-GI, Calgary Depression Scale for Schizophrenia, Brief Assessment of Cognition for Schizophrenia, and others.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
talnetantEXPERIMENTAL200mg, 400mg, 600mg) twice a day
placeboPLACEBO_COMPARATORplacebo
risperidoneACTIVE_COMPARATOR3mg twice a day

Interventions

NameTypeDescription
TalnetantDRUGtalnetant
placeboOTHERPlacebo Comparator
risperidoneOTHERActive Comparator
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion criteria: * Subjects must have schizophrenia which is not secondary to another medical condition or substance abuse. * Require inpatient hospitalization. * Woman may enroll only if they are not of child-bearing potential OR are on a protocol-approved birth control method. Exclusion crite...

Countries:United StatesAustraliaCanadaFranceGermanyNetherlandsSouth AfricaSpainSwedenUnited Kingdom
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Frequently asked questions about talnetant

What is talnetant used for?

Talnetant is an investigational small molecule being studied for irritable colon (irritable bowel syndrome) and schizophrenia. It has been evaluated in Phase 2 clinical trials for both conditions, but it is not approved and remains in clinical development.

Who makes talnetant?

Talnetant is being developed by GSK plc, traded on the London Stock Exchange under the ticker GSK. The company has sponsored multiple Phase 2 trials of the drug in schizophrenia and irritable bowel syndrome.

What phase is talnetant in?

Talnetant is in Phase 2 clinical development. All three completed trials were Phase 2 studies, including two in schizophrenia and one in irritable bowel syndrome. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is talnetant in?

Talnetant has completed three Phase 2 trials: NCT00049946 in schizophrenia (231 participants), NCT00101985 in irritable bowel syndrome (741 participants), and NCT00103727 in schizophrenia (282 participants). A fourth trial, NCT00300963, also studied talnetant in schizophrenia with 275 participants.

Is talnetant the same as other drugs?

Talnetant is not known by alternative names in the available data. It is a distinct investigational compound developed by GSK plc for gastrointestinal and psychiatric indications.