Recent Updates
Recently added Catalysts

TPIP F2

Phase 1

Undisclosed | Small molecule | Other |Insmed Incorporated|Trials Updated: Nov 21, 2025

TPIP F2 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2025

TPIP F2 target and mechanism

ModalitySmall molecule

Also known as INS1009

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

TPIP F2 clinical trials

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
Unlock Study Endpoints

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.
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about TPIP F2

What is TPIP F2?

TPIP F2 is an investigational small molecule developed by Insmed Incorporated. It is a formulation of treprostinil palmitil inhalation powder, known as Formulation 2, designed for administration by inhalation. It has been studied in a Phase 1 clinical trial in healthy volunteers.

Who makes TPIP F2?

TPIP F2 is being developed by Insmed Incorporated, which trades on the Nasdaq under the ticker INSM. The company is the sponsor of the clinical program evaluating this inhaled formulation.

What phase is TPIP F2 in?

TPIP F2 is in Phase 1 clinical development. One Phase 1 trial has been completed, and the program remains investigational rather than approved. No active trials of TPIP F2 are currently listed.

What clinical trials is TPIP F2 in?

TPIP F2 has been evaluated in one completed Phase 1 trial, NCT07102316. The study assessed the relative bioavailability of a single inhalation administration of TPIP Formulation 2 compared with TPIP Formulation 3 in healthy participants. It enrolled 42 participants in the United States and was controlled and randomized.

What is TPIP F2 used for?

TPIP F2 has been studied in healthy volunteers rather than in a patient population, so no therapeutic indication has been established for it. The completed Phase 1 trial, NCT07102316, evaluated relative bioavailability of the inhaled formulation in healthy participants aged 18 years and older.