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Tardive Dyskinesia

13
Pipeline Programs
6
Companies
15
Clinical Trials
1 recruiting
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
2
0
5
0
3
3
Early DiscoveryClinical DevelopmentMarket

On Market (2)

Approved therapies currently available

Neurocrine Biosciences
INGREZZAApproved
valbenazine
Neurocrine Biosciences
oral2017
1.7B Part D
Neurocrine Biosciences
INGREZZA SPRINKLEApproved
valbenazine
Neurocrine Biosciences
oral2024

Competitive Landscape

5 companies ranked by most advanced pipeline stage

Neurocrine Biosciences
10 programs
1
5
3
1
Valbenazine Oral CapsulePhase 41 trial
NBI-98854Phase 31 trial
NBI-98854Phase 31 trial
ValbenazinePhase 31 trial
NBI-1065890Phase 21 trial
+5 more programs
Active Trials
NCT05053321Withdrawn0Est. Oct 2025
NCT07365462Recruiting100Est. Mar 2027
NCT01733121Completed102Est. Dec 2013
+7 more trials
Luye Pharma
Luye PharmaChina - Shanghai
1 program
1
LPM3770164 sustained release tabletPhase 11 trial
Active Trials
NCT06216054Completed40Est. Jul 2024
Teva
TevaIsrael - Petach Tikva
2 programs
SD-809PHASE_2_31 trial
Deutetrabenazine Oral CapsulePHASE_41 trial
Active Trials
NCT02195700Completed117Est. May 2015
NCT06997198Not Yet Recruiting25Est. Oct 2027
Medicure
MedicureBarbados - Holetown
1 program
Pyridoxal 5'-PhosphatePHASE_21 trial
Active Trials
NCT00917293Terminated53Est. Aug 2014
UCB Pharma
UCB PharmaBelgium - Brussels
1 program
levetiracetamPHASE_31 trial
Active Trials
NCT00291213Completed50

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
TevaDeutetrabenazine Oral Capsule
Neurocrine BiosciencesValbenazine Oral Capsule
Neurocrine BiosciencesValbenazine
Neurocrine BiosciencesNBI-98854
Neurocrine BiosciencesNBI-98854
TevaSD-809
Neurocrine BiosciencesNBI-1065890
Neurocrine BiosciencesNBI-98854
Neurocrine BiosciencesNBI-98854
Neurocrine BiosciencesNBI-98854
Neurocrine BiosciencesNBI-98854
MedicurePyridoxal 5'-Phosphate
Neurocrine BiosciencesValbenazine
Luye PharmaLPM3770164 sustained release tablet

Clinical Trials (15)

Total enrollment: 1,205 patients across 15 trials

NCT06997198TevaDeutetrabenazine Oral Capsule

Deutetrabenazine Treatment for Tardive Dyskinesia in Intellectual/Developmental Disabilities

Start: May 2026Est. completion: Oct 202725 patients
Phase 4Not Yet Recruiting
NCT06107829Neurocrine BiosciencesValbenazine Oral Capsule

Valbenazine Treatment of Tardive Dyskinesia in Adults With Intellectual/Developmental Disabilities

Start: Jan 2025Est. completion: Feb 20270
Phase 4Withdrawn
NCT00291213UCB Pharmalevetiracetam

Levetiracetam Treatment of Tardive Dyskinesia

50 patients
Phase 3Completed
NCT02736955Neurocrine BiosciencesValbenazine

Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia

Start: Jun 2016Est. completion: Jun 2017161 patients
Phase 3Completed
NCT02405091Neurocrine BiosciencesNBI-98854

Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia

Start: Mar 2015Est. completion: Mar 2017167 patients
Phase 3Completed
NCT02274558Neurocrine BiosciencesNBI-98854

A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia

Start: Oct 2014Est. completion: Jul 2016234 patients
Phase 3Completed
NCT02195700TevaSD-809

Aim to Reduce Movements in Tardive Dyskinesia

Start: Jun 2014Est. completion: May 2015117 patients
Phase 2/3Completed
NCT07365462Neurocrine BiosciencesNBI-1065890

Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive Dyskinesia

Start: Feb 2026Est. completion: Mar 2027100 patients
Phase 2Recruiting
NCT01733121Neurocrine BiosciencesNBI-98854

NBI-98854 Dose Titration Study for the Treatment of Tardive Dyskinesia

Start: Dec 2012Est. completion: Dec 2013102 patients
Phase 2Completed
NCT01688037Neurocrine BiosciencesNBI-98854

NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder (KINECT Study)

Start: Sep 2012Est. completion: Oct 2013109 patients
Phase 2Completed
NCT01393600Neurocrine BiosciencesNBI-98854

NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder

Start: Aug 2011Est. completion: Feb 201237 patients
Phase 2Completed
NCT01267188Neurocrine BiosciencesNBI-98854

Efficacy and Safety of NBI-98854 in Subjects With Tardive Dyskinesia

Start: Jan 2011Est. completion: Mar 201110 patients
Phase 2Completed
NCT00917293MedicurePyridoxal 5'-Phosphate

Safety and Efficacy of Pyridoxal 5' -Phosphate in the Treatment of Tardive Dyskinesia

Start: May 2009Est. completion: Aug 201453 patients
Phase 2Terminated
NCT05053321Neurocrine BiosciencesValbenazine

Reduction of Demoralization in Patients With Tardive Dyskinesia After Treatment With Valbenazine

Start: Oct 2024Est. completion: Oct 20250
Phase 1Withdrawn
NCT06216054Luye PharmaLPM3770164 sustained release tablet

Safety, Tolerability and Pharmacokinetic of Multiple-ascending Doses of LPM3770164 in Healthy Subjects

Start: Dec 2023Est. completion: Jul 202440 patients
Phase 1Completed

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

3 late-stage (Phase 3) programs, potential near-term approvals
1 actively recruiting trials targeting 1,205 patients
6 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.