Treprostinil clinical trials
Treprostinil is named as an intervention in 5 current clinical trials in our USA, Mexico, Germany, France, Italy, Belgium, Canada, South Korea, Taiwan, Australia, Israel, UK, Spain, Netherlands and Denmark registers. 1 is recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is United Therapeutics (4). The most-studied condition is Progressive Pulmonary Fibrosis. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Treprostinil is approved
All regulators →Of the three regulators tracked here, the first to approve Treprostinil was the US, on 21 May 2002. It is approved in 3 of the 3 regulators tracked here.
- 3 EU orphan designations, most recently for treatment of idiopathic pulmonary fibrosis (16 Mar 2022, positive)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Treprostinil patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Treprostinil, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 19 listed patents; the last listed expires 3 Feb 2042 (US 11826327).
- Latest patent on the drug substance itself: 15 Dec 2028 (US 9593066).
- Exclusivity NP: New product, until 23 May 2028.
- Trepulmix for treatment of chronic thromboembolic pulmonary hypertension: until 7 Apr 2030. Union Register
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Treprostinil
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Treprostinil works
All drug targets →- Prostanoid IP receptor agonist AgonistTarget: PTGIR prostaglandin I2 receptor✓ In ChEMBL and the Guide to Pharmacology
- Idiopathic pulmonary arterial hypertensionPhase 3
- Idiopathic pulmonary fibrosisPhase 3
- Pulmonary fibrosisPhase 3
- Interstitial lung diseasePhase 2/3
- Exercise intolerancePhase 2
- HypoxemiaPhase 2
- CalcificationPhase 2
- Chronic obstructive pulmonary diseasePhase 2
- Persistent fetal circulation syndromePhase 2
- Systemic sclerosisPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1237119, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 5820, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Treprostinil
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 12 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: TrepulmixEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Treprostinil
- ATC code
- B01AC21
- ChEMBL
- CHEMBL1237119
- DrugBank
- DB00374
- PubChem CID
- 6918140
- CAS number
- 81846-19-7
- FDA UNII
- RUM6K67ESG
- Wikidata
- Q3495231
- Wikipedia
- Treprostinil
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Treprostinil
5 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Treprostinil in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Treprostinil. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of L606 (Treprostinil Liposome Inhalation Suspension) in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease (WHO Group 3)
2024-517943-29-00 · CTIS ↗ · Respiratory Tract Diseases
|
Phase 3 | Ongoing | Liquidia Technologies Inc | Latvia, Germany, Italy + 7 more |
Treprostinil across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
12 single-substance products containing Treprostinil on the HPRA medicines list.
- Treposuvi 10 mg/ml solution for infusionOrpha-Devel Handels und Vertriebs GmbH · PA1353/006/004 · Marketed
- Treposuvi 5 mg/ml solution for infusionOrpha-Devel Handels und Vertriebs GmbH · PA1353/006/003 · Marketed
- Trepulmix 1 mg/ml solution for infusionScipharm S.à.r.l. · EU/1/19/1419/001
- Trepulmix 10 mg/ml solution for infusionScipharm S.à.r.l. · EU/1/19/1419/004
- Trepulmix 2.5 mg/ml solution for infusionScipharm S.à.r.l. · EU/1/19/1419/002
Supply shortages
No entry for Treprostinil in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Treprostinil
5 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| United Therapeutics | 4 |
| Liquidia Technologies, Inc | 1 |
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Treprostinil trials
How many clinical trials are testing Treprostinil?
5 current trials in our USA, Mexico, Germany, France, Italy, Belgium, Canada, South Korea, Taiwan, Australia, Israel, UK, Spain, Netherlands and Denmark registers name Treprostinil (also registered as LIQ861 Treprostinil) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Treprostinil trials recruiting patients?
Yes. 1 of the 5 trials is recruiting: 1 with sites in USA, 1 with sites in Mexico, 1 with sites in Germany, 1 with sites in France, 1 with sites in Italy, 1 with sites in Belgium, 1 with sites in Canada, 1 with sites in South Korea, 1 with sites in Taiwan, 1 with sites in Australia, 1 with sites in Israel and 1 with sites in UK. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Treprostinil clinical trials?
United Therapeutics (4) and Liquidia Technologies, Inc (1). The number in brackets is how many trials each organisation leads.
Is Treprostinil licensed in Ireland?
Yes. The HPRA medicines list includes 12 single-substance products containing Treprostinil, for example Treposuvi 10 mg/ml solution for infusion (Orpha-Devel Handels und Vertriebs GmbH). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Treprostinil shortage?
Not in the lists we track: Treprostinil has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Treprostinil works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Treprostinil works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Treprostinil (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.