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TPIP F2

Phase 1

Healthy Volunteers | Small molecule | Other |Insmed Incorporated|Last Updated: Nov 21, 2025

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
RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment42
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07102316A Study to Assess the Relative Bioavailability After a Single Inhalation Administration of Treprostinil Palmitil Inhalation Powder (TPIP) Formulation 2 (F2) to TPIP Formulation 3 (F3) in Healthy ParticipantsPHASE1 COMPLETED 42Aug 19, 2025Nov 3, 2025Nov 21, 20251 United States
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Study Endpoints
Primary Endpoints
Maximum Observed Plasma Concentration (Cmax) of Treprostinil (TRE)
Pre-dose and post-dose at multiple timepoints up to Day 10
Area Under Plasma Concentration-Time Curve From 0 to Last Time Point With Quantifiable Concentration (AUClast) of TRE
Pre-dose and post-dose at multiple timepoints up to Day 10
Area Under Plasma Concentration-Time Curve From 0 to Infinity (AUCinf) of TRE
Pre-dose and post-dose at multiple timepoints up to Day 10
Secondary Endpoints
Time to Reach Maximum Observed Plasma Concentration (Tmax) of TRE
Pre-dose and post-dose at multiple timepoints up to Day 10
Terminal Elimination Half-Life (t1/2) of TRE
Pre-dose and post-dose at multiple timepoints up to Day 10
Apparent Clearance Following Inhalation Administration (CL/F) of TRE
Pre-dose and post-dose at multiple timepoints up to Day 10
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TPIP Dose AEXPERIMENTALParticipants will receive single dose of TPIP F2 or F3 on Day 1 in treatment period 1 followed by single dose of TPIP F3 or F2 on Day 1 in treatment period 2. Both treatment periods are separated by 7-day washout period.
TPIP Dose BEXPERIMENTALParticipants will receive single dose of TPIP F2 or F3 on Day 1 in treatment period 1 followed by single dose of TPIP F3 or F2 on Day 1 in treatment period 2. Both treatment periods are separated by 7-day washout period.
TPIP Dose CEXPERIMENTALParticipants will receive single dose of TPIP F2 or F3 on Day 1 in treatment period 1 followed by single dose of TPIP F3 or F2 on Day 1 in treatment period 2. Both treatment periods are separated by 7-day washout period.
Interventions
NameTypeDescription
TPIP F2DRUGInhalation using a capsule-based dry powder inhaler device.
TPIP F3DRUGInhalation using a capsule-based dry powder inhaler device.
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria * Body mass index (BMI): 18.0 to 32.0 kilogram per square metre (kg/m\^2), inclusive, at screening. * Weight: ≥50 kg (kilograms), inclusive, at screening. * Must be a nonsmoker (no use of tobacco or nicotine products) and/or has not used chewing tobacco for at least 1 month prior...

Countries:United States
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