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Deutetrabenazine

Phase 2

Huntington Disease | Small molecule | Rare Disease |Teva Pharmaceutical Industries Limited|Last Updated: Apr 14, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04713982Impact of Deutetrabenazine on Functional Speech and Gait Dynamics in Huntington DiseasePHASE2 ACTIVE NOT_RECRUITING 30Nov 19, 2021Oct 1, 2026Apr 14, 20261 United States
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Study Endpoints
Primary Endpoints
Sentence Intelligibility Test (SIT)
Up to 10 weeks

SIT is a measure of speech intelligibility that requires the participant to read aloud 11 sentences that increase in length from 5 to 10 words. Speech intelligibility is indexed in terms of percent intelligible. This is determined by calculating the mean number of correct words transcribed from the SIT transcriptions by three unfamiliar listeners and dividing this by the total number of words in the 11-sentence sample.

Motor Speech Evaluation (MSE)
Up to 10 weeks

The MSE will include a set of tasks described by Duffy (2013) that permit consistent rating of perceptual characteristics associated with motor speech disorders. These tasks include vowel prolongation, alternating motion rates, sequential motion rates, and contextual speech (oral reading, picture description, conversational speech). These recordings will be used to complete the perceptual assessment of speech characteristics using the Mayo Clinic classification system.

Secondary Endpoints
3-D optical motion capture system recording
Up to 10 weeks
Functional Joint Kinematics Improvements
Up to 10 weeks
Four Square Step Test (FSST)
Up to 10 Weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DeutetrabenazineEXPERIMENTALThe mode of administration is oral. Subjects will be started on deutetrabenazine at a dose of 6mg/day. Dosing will be up-titrated in increments of 6mg/day per week to achieve optimal chorea control.
Interventions
NameTypeDescription
DeutetrabenazineDRUGMaximum dose of 48mg/day or up to 36 mg/d if receiving a strong CYP2D6 inhibitor
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diagnosis of HD with documented CAG repeat ≥ 37 * UHDRS total maximal chorea score of ≥ 8 * Able to walk at least 10 meters * Medically stable outpatient, based on the investigator's judgment * Willing and able to give written informed consent prior to performing any study pro...

Countries:United States
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Competitive Landscape -Huntington's Disease 9 trials
Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT04713982studyFirstPostDate: changed