Recent Updates
Recently added Catalysts

HTX-034

Phase 1

Bunions | Small molecule | Other |Heron Therapeutics, Inc.|Last Updated: Feb 15, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment73
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04398329Dose-Escalation Study of HTX-034 Following BunionectomyPHASE1 COMPLETED 73 — — May 18, 2020Aug 3, 2021Feb 15, 20224 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Incidence of Treatment-emergent adverse events (TEAE's) (Phase 1B)
42 days
Mean area under the curve (AUC) of the NRS scores through 72 hours (AUC0-72) for the pooled Phase 1b and Phase 2
7 days
Secondary Endpoints
Maximum plasma concentration (Cmax) of HTX-034
29 days
Time of maximum plasma concentration (Tmax) of HTX-034
29 days
Area under the concentration-time curve from Time 0 to the time of the last quantitative concentration (AUClast) of HTX-034
29 days
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 1b (Cohort 1)EXPERIMENTALFixed dose of HTX-034.
Phase 1b (Cohort 2)EXPERIMENTALIndividualized dose of HTX-034.
Phase 2 (Expansion): Low DoseEXPERIMENTALFixed dose of HTX-034.
Phase 2 (Expansion): High DoseEXPERIMENTALIndividualized dose of HTX-034.
Phase 1b and Phase 2ACTIVE_COMPARATORBupivacaine HCl.
Interventions
NameTypeDescription
HTX-034DRUGHTX-034, low dose
Luer lock applicatorDEVICEApplicator for instillation
Bupivacaine HClDRUGBupivacaine HCl, 50 mg
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Is medically fit to undergo an elective unilateral, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia; no neuraxial technique (eg, no spinal, epidural, or general anesthesia). * Has an American Society of Anesthesiologists (ASA) Physi...

Countries:United States
Unlock Eligibility Criteria