ClinicalTrials.gg
AvailableNCT06939647Updated Oct 16, 2026

An Expanded Access Study to Assess Treprostinil Palmitil Inhalation Powder (TPIP) for Participants With Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

An expanded access record providing Treprostinil Palmitil in Pulmonary Arterial Hypertension and Pulmonary Hypertension, Interstitial Lung Disease, sponsored by Insmed Incorporated. Available. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by Insmed Incorporated · Expanded access

Study type
Expanded access
Access type
Treatment IND/protocol
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to provide continued access to TPIP for participants who have successfully completed the open-label extension (OLE) studies of INS1009-203 for PAH or INS1009-212 for PH-ILD.

Read the detailed description

Participants will receive TPIP 80 micrograms (μg), 160 μg, or 320 μg, inhalation single-dose capsules, orally, once daily (QD).

02

Conditions studied

  • Pulmonary Arterial Hypertension
  • Pulmonary Hypertension, Interstitial Lung Disease
03

In context

Pulmonary Arterial Hypertension

699 studies on the registry are indexed under Pulmonary Arterial Hypertension; 140 are open to participants now.

Browse Pulmonary Arterial Hypertension studies →

Lead sponsor

Insmed Incorporated is the lead sponsor of 50 studies on the registry; 8 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 8 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The participant is ineligible for or cannot be treated satisfactorily with alternative commercially available therapy for PAH or PH-ILD.
  • Participant provides their to participate as per local requirements.
  • Participant must have successfully completed the OLE INS1009-203 or INS1009-212 studies.
  • Based on the treating physician's judgement on participant's medical history and an evaluation of the overall risk-benefit profile, the participant will be determined to be suitable for continued TPIP treatment within this program.
  • Requests for the post-OLE INS1009-203 and INS1009-212 TPIP studies must originate from the investigators of INS1009-203 and INS1009-212 TPIP studies, respectively.
  • Female participants must be (defined as no menses for 12 months without an alternative medical cause), surgically sterile, or using highly effective (failure rate \<1% per year when used consistently and correctly) from Day 1 to at least 90 days after the last dose.
  • Male participants with female partners must adhere to contraception requirements to avoid potential exposure to the embryo/fetus based on the partner's reproductive status. For partners of , effective contraception must be used from Day 1 to at least 90 days after the last dose.

Exclusion criteria

Exclusion Criteria:

  • No specific exclusion criteria.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

05

Access details

Study type
Expanded access
Access type
Treatment IND/protocol

Available treatment

06

Where to request access

No study locations are listed for this record.

07

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 16, 2026
Show all 1 update
  1. Oct 16, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

08

Registry details

Key details

Study ID
NCT06939647
Responsible party
Sponsor
First posted
Apr 23, 2025
Last update
Oct 16, 2026

Study contacts

Insmed Medical Information
Contact
medicalinformation@insmed.com
18444467633
View the source record on ClinicalTrials.gov ↗

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

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Discussion

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