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Part 1

Phase 1

Drug Interaction | Small molecule | Other |Harmony Biosciences Holdings, Inc.|Last Updated: Feb 9, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment29
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06930872Drug Interaction Study of ZYN002 Transdermal Gel and Probe SubstratesPHASE1 COMPLETED 29 — — Jun 6, 2025Nov 4, 2025Feb 9, 20261 Australia
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Study Endpoints
Primary Endpoints
Maximum measure plasma concentration (Cmax) of probe substrates and metabolites
Days 1-3 (Period 1), Days 24-26 (Period 3)

Blood samples collected at pre dose, and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose.

Cmax of repaglinide and metabolite
Days 3 and 4 (Period 1), Days 26 and 27 (Period 3)

Blood samples collected at pre dose, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose.

Cmax of bupropion and metabolite
Days 4-10 (Period 1), Days 27-33 (Period 3)

Blood samples collected at pre dose and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post dose.

Cmax of CBD, delta-9-tetrahydrocannabinol (THC), and CBD metabolites
Days 24-33 (Period 3)

Blood samples collected at pre dose and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, and 144 hours post dose.

Amount excreted in urine over the collection period (Ae0-12) of CBD and its metabolites
Day 17 (Period 2), Days 24 and 32 (Period 3)

Urine samples collected over a 12-hour period.

Cmax of VPA and metabolite
Days 1-4 (Period 1), Days 18-21 (Period 3)

Blood samples collected at pre dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post dose.

Cmax of CBD, THC, and CBD metabolites
Days 18-21 (Period 3)

Blood samples collected at pre dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post dose.

Ae0-12 of VPA and metabolites
Days 1-4 (Period 1), Day 17 (Period 2), Days 18-20 (Period 3)

Urine samples collected over a 12-hour period.

Ae0-12 of ZYN002 and metabolites
Day 17 (Period 2), Days 18 and 20 (Period 3)

Urine samples collected over a 12-hour period.

Secondary Endpoints
Number of participants with skin irritation in ZYN002 application areas
Up to 33 days
Number of participants with abnormal physical examination results
Up to 33 days
Number of participants with abnormal clinical laboratory results
Up to 33 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeOTHER
Treatment Arms
ArmTypeDescription
Part 1: Interaction of ZYN002 and substratesEXPERIMENTALSubstrates: midazolam, omeprazole, losartan, dextromethorphan, caffeine, repaglinide, and bupropion
Part 2: Interaction of ZYN002 and VPAEXPERIMENTAL -
Interventions
NameTypeDescription
Part 1DRUGZYN002 (transdermal), midazolam (oral), omeprazole (oral), losartan (oral), dextromethorphan (oral), caffeine (oral), repaglinide (oral), bupropion (oral)
Part 2DRUGZYN002 (transdermal), VPA (oral)
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Male or female adults, 18-55 years of age, inclusive, at the time of Screening. 2. Judged by the Investigator to be in generally good health at Screening based upon the results of a medical history, physical examination, 12-lead ECG, and clinical laboratory test results. Labo...

Countries:Australia
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