Neurocrine Biosciences Pipeline & Clinical Trials

Archive historyOct 2022 to Jul 2026

134 recorded changes across Neurocrine Biosciences trials

Every status move, completion date shift and enrollment change ComplyRx has recorded across 38 of these trials. One is shown below.

Completion date movePrimary completion moved 702 days laterNCT06312189 · recorded 28 Jul 2026

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+130 more recorded changes · Track a drug to see every change the night it lands

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Most active programmes

The drugs appearing most often across Neurocrine Biosciences's recently active trials. Comparator arms are excluded.

Valbenazine15 trials
NBI-9885413 trials
NBI-10658456 trials
NBI-11175686 trials
Chronocort5 trials
NBI-9213524 trials

Upcoming readouts

Next primary completion dates among Neurocrine Biosciences's active phase 2 and phase 3 trials. Dates are registry estimates and move often, which is exactly what the tracker watches.

Feb 2027Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive Dyskines…Phase 2
Jul 2027NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Tre…Phase 3
Jul 2027NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Tre…Phase 3
Jul 2027Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participant…Phase 3
Aug 2027Evaluation of NBI-1117570 in Inpatient Adults With SchizophreniaPhase 2
Oct 2027NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With SchizophreniaPhase 3

Top therapeutic areas

Conditions studied most often across Neurocrine Biosciences's recently active trials.

Schizophrenia14 trials
Congenital Adrenal Hyperplasia11 trials
Tardive Dyskinesia11 trials
Major Depressive Disorder10 trials
Adrenal Insufficiency9 trials
Tourette Syndrome8 trials

Neurocrine Biosciences pipeline by phase

The main study drugs across 16 active trials Neurocrine Biosciences leads on ClinicalTrials.gov. Each drug sits in the highest phase among its currently active trials, which can be lower than a phase it has already completed.

Phase 33 drugs

Neurocrine Biosciences phase 3 drugs, most trials first
Drug	Trials	Recruiting	Next readout	Sample trials
NBI-1065845	5	5	Jul 2027 est.	NCT07196501 · NCT06966401 · NCT06963021
NBI-1117568	5	5	Oct 2027 est.	NCT07227818 · NCT07114874 · NCT07105098
Crinecerfont	2	—	—	NCT04806451 · NCT04490915

Phase 22 drugs

Neurocrine Biosciences phase 2 drugs, most trials first
Drug	Trials	Recruiting	Next readout	Sample trials
NBI-1065890	1	1	Feb 2027 est.	NCT07365462
NBI-1117570	1	1	Aug 2027 est.	NCT07288333

Phase 41 drug

Neurocrine Biosciences phase 4 drugs, most trials first
Drug	Trials	Recruiting	Next readout	Sample trials
Valbenazine	2	1	Jan 2027 est.	NCT07105111 · NCT06312189

Derived from 16 active trials Neurocrine Biosciences leads; 16 name an intervention, folding into 6 phased drugs. This is ComplyRx's reading of the registry, not Neurocrine Biosciences's own pipeline disclosure.

Neurocrine Biosciences trials

The 50 most significant of Neurocrine Biosciences's recently active trials, soonest estimated readout first.
Select any row for the full record; the change timeline unlocks with tracking.

Trial	Phase	Stability	Status	Enrollment	Est. readout
A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) InhibitorNCT07105111Valbenazine	Phase 4	Locked · track to reveal	OngoingRecruiting	50 est.	Jan 2027
Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive DyskinesiaNCT07365462NBI-1065890	Phase 2	Locked · track to reveal	OngoingRecruiting	100 est.	Feb 2027
NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)NCT06911112NBI-1065845	Phase 3	Locked · track to reveal	OngoingRecruiting	200 est.	Jul 2027
NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)NCT06963021NBI-1065845	Phase 3	Locked · track to reveal	OngoingRecruiting	200 est.	Jul 2027
Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)NCT06786624NBI-1065845	Phase 3	Locked · track to reveal	OngoingRecruiting	200 est.	Jul 2027
Evaluation of NBI-1117570 in Inpatient Adults With SchizophreniaNCT07288333NBI-1117570	Phase 2	Locked · track to reveal	OngoingRecruiting	120 est.	Aug 2027
NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With SchizophreniaNCT06963034NBI-1117568	Phase 3	Locked · track to reveal	OngoingRecruiting	284 est.	Oct 2027
NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With SchizophreniaNCT07105098NBI-1117568	Phase 3	Locked · track to reveal	OngoingRecruiting	284 est.	Nov 2027
An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current ManiaNCT07288320NBI-1117568	Phase 2	Locked · track to reveal	OngoingRecruiting	150 est.	Feb 2028
Long-term Study to Evaluate Safety and Tolerability of Valbenazine in Participants With Chorea Associated With Huntington Disease in CanadaNCT06312189Valbenazine	Phase 3	Locked · track to reveal	OngoingEnrolling by invitation	7 est.	Apr 2028
A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)NCT07196501NBI-1065845	Phase 3	Locked · track to reveal	OngoingRecruiting	550 est.	Jul 2028
Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)NCT06966401NBI-1065845	Phase 3	Locked · track to reveal	OngoingRecruiting	850 est.	May 2029
Efficacy of NBI-1117568 in Preventing Relapse in Adults With SchizophreniaNCT07227818NBI-1117568	Phase 3	Locked · track to reveal	OngoingRecruiting	560 est.	Jul 2029
NBI-1117568-SCZ3032: Long-Term Evaluation of NBI-1117568 in Adults With SchizophreniaNCT07114874NBI-1117568	Phase 3	Locked · track to reveal	OngoingRecruiting	600 est.	Dec 2031
Extension Study to Evaluate How Safe and Tolerable NBI-921352 is as an Adjunctive Therapy for Participants With SCN8A-DEENCT05226780NBI-921352	Phase 2	Locked · track to reveal	StoppedTerminated	8 est.	12 Nov 2025
Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated With Huntington DiseaseNCT04400331Valbenazine	Phase 3	Locked · track to reveal	Completed	154 est.	5 Nov 2025
Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Dyskinesia Due to Cerebral PalsyNCT05206513Valbenazine	Phase 3	Locked · track to reveal	Completed	86 est.	16 Oct 2025
A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive DisorderNCT06267846NBI-1070770	Phase 2	Locked · track to reveal	Completed	73 est.	25 Jul 2025
Journey Study: Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment for SchizophreniaNCT05110157Valbenazine	Phase 3	Locked · track to reveal	Completed	442 est.	4 Feb 2025
Steamboat 2Extension Study to Evaluate NBI-827104 in Pediatric Participants With Epileptic Encephalopathy With Continuous Spike-and-Wave During SleepNCT05301894NBI-827104	Phase 2	Locked · track to reveal	StoppedTerminated	19 est.	27 Jan 2025
Study of the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Participants With Tardive DyskinesiaNCT05859698Valbenazine	Phase 4	Locked · track to reveal	Completed	59 est.	27 Dec 2024
VY-AADC02 for Parkinson's Disease With Motor Fluctuations (RESTORE-1)NCT03562494VY-AADC02	Phase 1	Locked · track to reveal	Completed	14 est.	30 Oct 2024
Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With SchizophreniaNCT05545111NBI-1117568	Phase 2	Locked · track to reveal	Completed	210 est.	10 Jul 2024
ERUDITEStudy to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Participants With Cognitive Impairment Associated With SchizophreniaNCT05182476Luvadaxistat	Phase 2	Locked · track to reveal	StoppedTerminated	216 est.	28 Jun 2024
Extension Study to Evaluate the Safety and Tolerability of NBI-921352 When Used With Anti-seizure Medications in Adults With Focal Onset SeizuresNCT05493293NBI-921352	Phase 2	Locked · track to reveal	StoppedTerminated	82 est.	11 Mar 2024
CONnECTComparison of Chronocort Versus Standard Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal HyperplasiaNCT05063994Chronocort	Phase 3	Locked · track to reveal	Completed	55 est.	2 Feb 2024
SAVITRIStudy to Assess the Efficacy and Safety of NBI-1065845 in Adults With Major Depressive Disorder (MDD)NCT05203341NBI-1065845	Phase 2	Locked · track to reveal	Completed	183 est.	10 Jan 2024
Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as an Adjunctive Treatment for SchizophreniaNCT05654870Valbenazine	Phase 3	Locked · track to reveal	StoppedTerminated	8 est.	8 Nov 2023
CHAMPAINChronocort Versus Plenadren Replacement Therapy in Adults With Adrenal InsufficiencyNCT05222152Chronocort	Phase 2	Locked · track to reveal	Completed	58 est.	18 Oct 2023
A Study to Investigate How Effective, Safe and Tolerable the Drug NBI-921352 is When Used With Anti-seizure Medications in Adults With Focal Onset SeizuresNCT05159908NBI-921352	Phase 2	Locked · track to reveal	Completed	101 est.	21 Aug 2023
CAHtalystGlobal Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal HyperplasiaNCT04490915Crinecerfont	Phase 3	Locked · track to reveal	OngoingActive, not recruiting	182 est.	19 Jul 2023
Observational, Long-term Extension Study for Participants of Prior VY-AADC01 StudiesNCT03733496	—	Not yet scored	Completed	14 est.	18 Jul 2023
TERPSISStudy to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in MDDNCT05165394NBI-1065846	Phase 2	Locked · track to reveal	Completed	93 est.	7 Jul 2023
Study to Evaluate NBI-921352 as Adjunctive Therapy in Subjects With SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE)NCT04873869NBI-921352	Phase 2	Locked · track to reveal	StoppedTerminated	8 est.	17 Mar 2023
Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)NCT04806451Crinecerfont	Phase 3	Locked · track to reveal	OngoingActive, not recruiting	103 est.	10 Mar 2023
Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During SleepNCT04625101NBI-827104	Phase 2	Locked · track to reveal	Completed	24 est.	8 Aug 2022
OPTI-ONOpicapone Treatment Initiation Open-Label StudyNCT04787965Opicapone	—	Not yet scored	Completed	239 est.	4 Aug 2022
A Study of the Efficacy, Safety and Tolerability of Chronocort in Treating CAHNCT03062280Hydrocortisone	Phase 3	Locked · track to reveal	Completed	91 est.	13 Jul 2022
Safety, Efficacy, and Tolerability of NBI-827104 for the Treatment of Essential TremorNCT04880616NBI-827104	Phase 2	Locked · track to reveal	Completed	31 est.	25 May 2022
KINECT-HDEfficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington DiseaseNCT04102579Valbenazine	Phase 3	Locked · track to reveal	Completed	128 est.	15 Oct 2021
Safety and Efficacy Study of VY-AADC01 for Advanced Parkinson's DiseaseNCT03065192VY-AADC01	Phase 1	Locked · track to reveal	Completed	16 est.	10 Aug 2021
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 (Crinecerfont) in Pediatric Participants With Congenital Adrenal HyperplasiaNCT04045145Crinecerfont	Phase 2	Locked · track to reveal	Completed	8 est.	2 Jul 2021
A Study to Evaluate 3 Dose Levels of Luvadaxistat of Adults With Negative Symptoms of SchizophreniaNCT03382639Luvadaxistat	Phase 2	Locked · track to reveal	Completed	256 est.	29 Dec 2020
A Study to Evaluate Multiple Oral Doses of Luvadaxistat in Adults With SchizophreniaNCT03359785Luvadaxistat	Phase 2	Locked · track to reveal	Completed	31 est.	21 Dec 2020
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Adults With Congenital Adrenal HyperplasiaNCT03525886NBI-74788	Phase 2	Locked · track to reveal	Completed	18 est.	7 Apr 2020
A Study to Assess Absolute Bioavailability (ABA) of TAK-831 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]TAK-831 in Male Healthy ParticipantsNCT04234672TAK-831 Oral Tablet	Phase 1	Locked · track to reveal	Completed	6 est.	4 Apr 2020
AADCSafety Study of AADC Gene Therapy (VY-AADC01) for Parkinson's DiseaseNCT01973543VY-AADC01	Phase 1	Locked · track to reveal	Completed	15 est.	24 Jan 2020
Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive DyskinesiaNCT03891862Valbenazine	Phase 4	Locked · track to reveal	Completed	135 est.	23 Dec 2019
Phase 1 TAK-041 First-in-Human Safety, Tolerability, and Pharmacokinetics StudyNCT02748694TAK-041	Phase 1	Locked · track to reveal	Completed	114 est.	22 Sept 2019
A Randomized, Double-Blind, Placebo Controlled, Two-Period Cross-Over, Proof of Activity Study to Evaluate the Effects of TAK-041 on Motivational Anhedonia as Add-On to Antipsychotics in Participants With Stable SchizophreniaNCT03319953TAK-041	Phase 2	Locked · track to reveal	Completed	23 est.	11 Sept 2019

View all trials102

A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor

Phase 4RecruitingNCT07105111 ↗

Primary completion: Jan 2027; estimated
Enrollment: 50; estimated
Start: Aug 2025; Neurocrine Biosciences

Conditions

Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Major Depressive Disorder
Tardive Dyskinesia

Interventions

Valbenazine

Brief summary

This study will evaluate the efficacy of valbenazine on clinician- and patient-reported outcomes in participants with TD while receiving or after stopping a VMAT2 inhibitor.

Full record on ClinicalTrials.gov ↗

Change timeline

3 recorded · latest 28 Jul 2026

Completion date move · 2

Status change · 1

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Steamboat 2: Extension Study to Evaluate NBI-827104 in Pediatric Participants With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep

Phase 2TerminatedNCT05301894 ↗

Primary completion: Jan 2025; actual
Enrollment: 19; estimated
Start: Jun 2022; Neurocrine Biosciences

Conditions

Epileptic Encephalopathy
Continuous Spike and Wave During Sleep

Interventions

NBI-827104

Brief summary

The primary objective for this study is to evaluate the long-term safety and tolerability of NBI-827104 in pediatric participants with epileptic encephalopathy with continuous spike-and-wave during sleep (EECSWS).

Full record on ClinicalTrials.gov ↗

Change timeline

7 recorded · latest 1 Apr 2025

Status change · 3

Completion date move · 3

Enrollment change · 1

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Study of the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Participants With Tardive Dyskinesia

Phase 4CompletedNCT05859698 ↗

Primary completion: Dec 2024; actual
Enrollment: 59; estimated
Start: May 2023; Neurocrine Biosciences

Conditions

Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Major Depressive Disorder
Tardive Dyskinesia

Interventions

Valbenazine

Brief summary

This study will evaluate the effectiveness of valbenazine on patient- and clinician-reported outcomes assessing health-related quality of life, functioning, and treatment effect in participants with tardive dyskinesia (TD) who are receiving valbenazine for up to 24 weeks.

Full record on ClinicalTrials.gov ↗

Change timeline

5 recorded · latest 1 Apr 2025

Status change · 2

Completion date move · 2

Enrollment change · 1

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Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia

Phase 2CompletedNCT05545111 ↗

Primary completion: Jul 2024; actual
Enrollment: 210; estimated
Start: Oct 2022; Neurocrine Biosciences

Conditions

Schizophrenia

Interventions

NBI-1117568
Placebo

Brief summary

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, multi-arm, multi-stage inpatient study designed to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of NBI-1117568 compared with placebo in adult subjects with a primary diagnosis of schizophrenia, who are experiencing an…

Full record on ClinicalTrials.gov ↗

Change timeline

4 recorded · latest 1 Oct 2024

Status change · 2

Completion date move · 1

Enrollment change · 1

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Extension Study to Evaluate the Safety and Tolerability of NBI-921352 When Used With Anti-seizure Medications in Adults With Focal Onset Seizures

Phase 2TerminatedNCT05493293 ↗

Primary completion: Mar 2024; actual
Enrollment: 82; estimated
Start: Nov 2022; Neurocrine Biosciences

Conditions

Focal Onset Seizure
Focal Onset Epilepsy

Interventions

NBI-921352

Brief summary

This Phase 2, prospective, interventional, active extension study was designed to evaluate the long-term safety and tolerability of NBI-921352 as adjunctive therapy in adult participants with focal onset seizures who completed 11 weeks of treatment in randomized, double-blind, placebo-controlled Study…

Full record on ClinicalTrials.gov ↗

Change timeline

4 recorded · latest 1 Jul 2024

Status change · 2

Enrollment change · 1

Completion date move · 1

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CONnECT: Comparison of Chronocort Versus Standard Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia

Phase 3CompletedNCT05063994 ↗

Primary completion: Feb 2024; actual
Enrollment: 55; estimated
Start: May 2022; Neurocrine UK Limited

Conditions

Congenital Adrenal Hyperplasia

Interventions

Chronocort
Cortef
Placebo

Brief summary

This study is a randomized, double-blind, active-controlled, phase III study of Chronocort® compared with immediate-release hydrocortisone replacement therapy in participants aged 16 years and over with Congenital Adrenal Hyperplasia.

Full record on ClinicalTrials.gov ↗

Change timeline

5 recorded · latest 1 Apr 2024

Completion date move · 2

Status change · 2

Enrollment change · 1

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CHAMPAIN: Chronocort Versus Plenadren Replacement Therapy in Adults With Adrenal Insufficiency

Phase 2CompletedNCT05222152 ↗

Primary completion: Oct 2023; actual
Enrollment: 58; estimated
Start: Nov 2021; Neurocrine UK Limited

Conditions

Primary Adrenal Insufficiency

Interventions

Chronocort
Plenadren

Brief summary

This study is a double-blind, double-dummy, two-way cross-over, randomised, Phase II study to be conducted at approximately 6 investigational sites in 2 countries. The study will compare the efficacy, safety and tolerability of twice daily Chronocort, a modified-release hydrocortisone, with once daily Plenadren, a…

Full record on ClinicalTrials.gov ↗

Change timeline

7 recorded · latest 1 Jul 2024

Completion date move · 4

Status change · 2

Enrollment change · 1

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CAHtalyst: Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia

Phase 3Active, not recruitingNCT04490915 ↗

Primary completion: Jul 2023; actual
Enrollment: 182; estimated
Start: Dec 2020; Neurocrine Biosciences

Conditions

Congenital Adrenal Hyperplasia

Interventions

Crinecerfont
Placebo

Brief summary

This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 24 weeks in approximately 165 adult participants with classic CAH due to 21-hydroxylase deficiency. The study consists of a 24-week randomized, double-blind, placebo-controlled period, followed by…

Full record on ClinicalTrials.gov ↗

Change timeline

4 recorded · latest 1 Oct 2023

Completion date move · 2

Status change · 1

Enrollment change · 1

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Study to Evaluate NBI-921352 as Adjunctive Therapy in Subjects With SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE)

Phase 2TerminatedNCT04873869 ↗

Primary completion: Mar 2023; actual
Enrollment: 8; estimated
Start: Jan 2022; Neurocrine Biosciences

Conditions

SCN8A Developmental and Epileptic Encephalopathy Syndrome

Interventions

NBI-921352
Placebo

Brief summary

The objective of this study is to assess the efficacy, safety, and pharmacokinetics of NBI-921352 as adjunctive therapy for seizures in subjects with SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE).

Full record on ClinicalTrials.gov ↗

Change timeline

5 recorded · latest 1 Aug 2025

Completion date move · 2

Status change · 2

Enrollment change · 1

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Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)

Phase 3Active, not recruitingNCT04806451 ↗

Primary completion: Mar 2023; actual
Enrollment: 103; estimated
Start: Jun 2021; Neurocrine Biosciences

Conditions

Congenital Adrenal Hyperplasia

Interventions

Crinecerfont
Placebo

Brief summary

This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 28 weeks in approximately 81 pediatric participants with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. The study consists of a 28-week double blind,…

Full record on ClinicalTrials.gov ↗

Change timeline

4 recorded · latest 1 Oct 2023

Completion date move · 2

Status change · 1

Enrollment change · 1

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Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep

Phase 2CompletedNCT04625101 ↗

Primary completion: Aug 2022; actual
Enrollment: 24; estimated
Start: Apr 2021; Neurocrine Biosciences

Conditions

Epileptic Encephalopathy
Continuous Spike and Wave During Sleep

Interventions

NBI-827104
Placebo

Brief summary

This is a phase 2, double-blind study to assess the efficacy, safety, tolerability, and pharmacokinetics of NBI-827104 when administered once daily for 13 weeks in pediatric subjects with Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep (EECSWS).

Full record on ClinicalTrials.gov ↗

Change timeline

5 recorded · latest 1 Apr 2023

Status change · 2

Completion date move · 2

Enrollment change · 1

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A Study to Assess Absolute Bioavailability (ABA) of TAK-831 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]TAK-831 in Male Healthy Participants

Phase 1CompletedNCT04234672 ↗

Primary completion: Apr 2020; actual
Enrollment: 6; estimated
Start: Feb 2020; Neurocrine Biosciences

Conditions

Healthy Volunteers

Interventions

TAK-831 Oral Tablet
[14C]TAK-831 IV Infusion
[14C]TAK-831 Oral Suspension

Brief summary

The purpose of this study is to determine ABA of TAK-831 following a single microdose intravenous administration of 50 microgram (μg) (approximately 1 microcurie \[μCi\]) \[14C\]TAK-831 and a single oral administration of 500 milligram (mg) TAK-831 tablets in Period 1, and to assess the mass balance, characterize the…

Full record on ClinicalTrials.gov ↗

Change timeline

No changes recorded on this trial in the observed window.

A Randomized, Double-Blind, Placebo Controlled, Two-Period Cross-Over, Proof of Activity Study to Evaluate the Effects of TAK-041 on Motivational Anhedonia as Add-On to Antipsychotics in Participants With Stable Schizophrenia

Phase 2CompletedNCT03319953 ↗

Primary completion: Sept 2019; actual
Enrollment: 23; estimated
Start: Dec 2017; Neurocrine Biosciences

Conditions

Stable Schizophrenia

Interventions

TAK-041
Placebo
Second Generation Antipsychotics (SGA)

Brief summary

The purpose of the study is to determine whether motivation/reward deficits observed in schizophrenia are attenuated and whether cognitive impairment associated with schizophrenia is improved by add-on TAK-041 administration to antipsychotics in participants with stable schizophrenia.

Full record on ClinicalTrials.gov ↗

Change timeline

No changes recorded on this trial in the observed window.