102 Participants Needed

Treprostinil Palmitil for Pulmonary Arterial Hypertension

Recruiting at 98 trial locations
IM
Overseen ByInsmed Medical Information
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Insmed Incorporated
Must be taking: Endothelin antagonists, PDE5 inhibitors
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I have to stop taking my current medications?

The trial requires participants to stay on their current pulmonary hypertension medications, which can include up to two drugs from specific classes like endothelin receptor antagonists, phosphoesterase type 5 inhibitors, or guanylate cyclase stimulators. There should be no change in these medications or their dosages for at least 30 days before the screening.

What data supports the idea that the drug Treprostinil Palmitil for Pulmonary Arterial Hypertension is an effective treatment?

The available research does not provide any data on Treprostinil Palmitil for Pulmonary Arterial Hypertension. Instead, it focuses on treatments for erectile dysfunction, such as alprostadil and sildenafil. Therefore, there is no information here to support the effectiveness of Treprostinil Palmitil for Pulmonary Arterial Hypertension.12345

What safety data is available for Treprostinil Palmitil in treating pulmonary arterial hypertension?

Treprostinil Palmitil, in its various formulations such as TPIP and TPIS, has been evaluated for safety in several studies. A Phase 1 study assessed the safety, tolerability, and pharmacokinetics of TPIP in healthy volunteers, indicating it is well-tolerated with fewer respiratory-related side effects compared to inhaled Treprostinil. Preclinical studies in animals showed that TPIS maintained high lung concentrations with low systemic exposure, and no cough was observed at doses where Treprostinil caused cough. Additionally, there was no evidence of tachyphylaxis with repeated dosing in rats. Overall, these studies suggest that Treprostinil Palmitil formulations are safe and may offer advantages over existing Treprostinil treatments.678910

Is Treprostinil Palmitil a promising drug for Pulmonary Arterial Hypertension?

Yes, Treprostinil Palmitil is a promising drug for Pulmonary Arterial Hypertension. It is designed to be inhaled, which allows it to work directly in the lungs and provide long-lasting effects. This means it can be taken less often, possibly just once a day, which is more convenient for patients. Studies show it works well in reducing lung and heart problems related to the disease and is better tolerated than some other forms of the drug.678911

What is the purpose of this trial?

This trial is testing an inhalable medicine called TPIP to see if it can help people with high blood pressure in their lungs by making it easier for blood to flow through their lung arteries.

Eligibility Criteria

Adults aged 18-75 with Pulmonary Arterial Hypertension (PAH) who are on stable PH therapy can join this trial. They must not smoke, have a history of certain heart diseases or infections, and women should use effective contraception. Participants need to be able to perform physical tests like walking.

Inclusion Criteria

I have been diagnosed with pulmonary arterial hypertension for over 3 months.
I've been on the same pulmonary hypertension medication for at least 30 days.
I am following the required guidelines for contraception, sterilization, or am post-menopausal.
See 4 more

Exclusion Criteria

I have a history of blood clots, liver disease, HIV, hepatitis B or C, or symptomatic COVID-19.
I am allergic or sensitive to certain medications.
I have a history of pulmonary hypertension, but not the specified types.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treprostinil palmitil inhalation powder or placebo once per day, with up-titration over the first 3 weeks to the highest tolerated dose, for a total of 16 weeks

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Placebo
  • Treprostinil Palmitil
Trial Overview The study is testing Treprostinil Palmitil inhalation powder against a placebo to see if it improves blood flow resistance in the lungs for PAH patients. The participants will either receive the actual drug or a placebo without knowing which one they're getting.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treprostinil Palmitil Inhalation PowderExperimental Treatment1 Intervention
Participants will be administered TPIP once per day at a starting dose of 80 micrograms (μg). Participants will be up-titrated to the highest tolerated dose for each individual participant of between 80 μg and 640 μg during the initial 3 weeks of treatment. The overall treatment period will be 16 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants will be administered a placebo matching TPIP once per day for 16 weeks.

Treprostinil Palmitil is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Treprostinil palmitil for:
  • Pulmonary arterial hypertension
🇪🇺
Approved in European Union as Treprostinil palmitil for:
  • Pulmonary arterial hypertension

Find a Clinic Near You

Who Is Running the Clinical Trial?

Insmed Incorporated

Lead Sponsor

Trials
44
Recruited
7,600+

Findings from Research

In a study of 187 patients with erectile dysfunction, both alprostadil and a combination of vasoactive intestinal polypeptide (VIP) and phentolamine were effective, with 83% of alprostadil users achieving a suitable erection compared to 73% for VIP/phentolamine.
Patients significantly preferred the VIP/phentolamine combination due to its lower incidence of pain (3% vs. 28% for alprostadil), despite both treatments being similarly effective in producing erections.
Injection therapy for the treatment of erectile dysfunction: a comparison between alprostadil and a combination of vasoactive intestinal polypeptide and phentolamine mesilate.Shah, PJ., Dinsmore, W., Oakes, RA., et al.[2013]
In a study of 55 patients with erectile dysfunction due to atherosclerosis, both sildenafil and alprostadil improved penile rigidity, but only alprostadil and sildenafil significantly increased arterial penile inflow (PSV) in patients with vasculogenic impotency.
The findings suggest that alprostadil and sildenafil should be considered first-line treatments for men with vasculogenic impotency, while alprostadil is not recommended as the initial treatment for those with nonvasculogenic impotency.
Sildenafil citrate vs intracavernous alprostadil for patients with arteriogenic erectile dysfunction: a randomised placebo controlled study.Mancini, M., Raina, R., Agarwal, A., et al.[2016]
In a study of 115 men with erectile dysfunction, only 30% achieved sufficient erections for intercourse using the Medicated Urethral System for Erection (MUSE) at the highest dose of 1,000 microg, indicating limited efficacy compared to expectations from previous studies.
The treatment was associated with significant discomfort and adverse events, including pain and orthostatic hypotension, leading to over 80% of participants discontinuing use at home due to these side effects and the cost of the treatment.
Disappointing initial results with transurethral alprostadil for erectile dysfunction in a urology practice setting.Fulgham, PF., Cochran, JS., Denman, JL., et al.[2019]

References

Injection therapy for the treatment of erectile dysfunction: a comparison between alprostadil and a combination of vasoactive intestinal polypeptide and phentolamine mesilate. [2013]
Sildenafil citrate vs intracavernous alprostadil for patients with arteriogenic erectile dysfunction: a randomised placebo controlled study. [2016]
Disappointing initial results with transurethral alprostadil for erectile dysfunction in a urology practice setting. [2019]
Intraurethral alprostadil for erectile dysfunction: a review of the literature. [2021]
Use of intraurethral alprostadil in patients not responding to sildenafil citrate. [2015]
Treprostinil palmitil, an inhaled long-acting pulmonary vasodilator, does not show tachyphylaxis with daily dosing in rats. [2021]
Safety, Tolerability, and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder for Pulmonary Hypertension: A Phase 1, Randomized, Double-Blind, Single- and Multiple-Dose Study. [2023]
Development and Characterization of Treprostinil Palmitil Inhalation Aerosol for the Investigational Treatment of Pulmonary Arterial Hypertension. [2021]
An overview of the biology of a long-acting inhaled treprostinil prodrug. [2021]
Effect of Inhalation Profile on Delivery of Treprostinil Palmitil Inhalation Powder. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Assessment of Inhaled Treprostinil Palmitil, Inhaled and Intravenous Treprostinil, and Oral Selexipag in a Sugen/Hypoxia Rat Model of Pulmonary Arterial Hypertension. [2022]
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