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TPIP F2

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

Clinical trial landscape

TPIP F2 · 1 trial · 1 indication

Phase 1 1
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 ParticipantsHealthy Volunteers
COMPLETED42 Analytics
PHASE1COMPLETED
A 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 Participants
Healthy VolunteersUnlock trial analytics

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 to 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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Frequently asked questions about TPIP F2

What is TPIP F2 used for?

TPIP F2 is an investigational small molecule being studied in healthy volunteers. It is a formulation of treprostinil palmitil inhalation powder, specifically Formulation 2, and is being evaluated for its relative bioavailability compared to another formulation. It is not approved for any disease and is in early clinical development.

Who makes TPIP F2?

TPIP F2 is being developed by Insmed Incorporated, a biopharmaceutical company traded on NASDAQ under the ticker INSM. The company is conducting clinical research on this investigational drug candidate.

What phase is TPIP F2 in?

TPIP F2 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 study has been completed, and the drug remains in early-stage clinical research.

What clinical trials is TPIP F2 in?

TPIP F2 has one completed Phase 1 clinical trial, identified as NCT07102316. The study assessed the relative bioavailability after a single inhalation administration of TPIP Formulation 2 compared to Formulation 3 in healthy participants. The trial enrolled 42 participants in the United States.

Is TPIP F2 the same as treprostinil palmitil?

TPIP F2 is a specific formulation of treprostinil palmitil inhalation powder, referred to as Formulation 2. It is being compared to Formulation 3 in clinical trials. Treprostinil palmitil is the active moiety, and TPIP F2 is one of its formulations under investigation.