This page shows what was measured, who it was measured in, and what that does not settle.
What (3R)-TREPROSTINIL does in the body
Pulmonary arterial hypertension (PAH
From the FDA-approved label: The major pharmacologic actions of treprostinil are direct vasodilation of pulmonary and systemic arterial vascular beds, inhibition of platelet aggregation, and inhibition of smooth muscle cell proliferation.
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.
What the registries record it as
Its recorded molecular formula is C23H34O5, weighing 390.52.
US prescribing information · cbc31ab1-a80f-4b50-a3b1-39910b0fb609 · read 2026-08-30
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
No statement of the main limit is recorded.
The four opening statements run to 48 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Formulation
A formulation is the exact made-up form a substance comes in.
A picture of it, and where the picture fails
It is like the difference between a whole bean and instant coffee.
Where that stops being true. Coffee tastes different. A formulation can change how much reaches the blood.
What people get wrong. Two products with the same name are assumed to behave the same. They often do not.
The specific composition and physical form of a product, including salt, excipients and release profile.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Long-term safety and tolerability of inhaled treprostinil in subjects with IPF or PPF
✗ The study did not show it
Who was studied
NCT04905693
How many people
1850
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous, subcutaneous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Change in Exercise Capacity at Month 12
✗ The study did not show it
Who was studied
NCT01027949
How many people
894
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
What a body can do day to day
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous, subcutaneous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Change in Absolute FVC from Baseline to Week 52
✗ The study did not show it
Who was studied
NCT05943535
How many people
698
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous, subcutaneous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Time to First Clinical Worsening Event
✗ The study did not show it
Who was studied
NCT01560624
How many people
690
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous, subcutaneous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Change in Absolute FVC from Baseline to Week 52
✗ The study did not show it
Who was studied
NCT04708782
How many people
598
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous, subcutaneous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Change in Absolute FVC from Baseline to Week 52
✗ The study did not show it
Who was studied
NCT05255991
How many people
597
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous, subcutaneous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Tyvaso is a prostacyclin mimetic indicated for the treatment of: Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%).
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “Safety and effectiveness in pediatric patients have not been established.”
US prescribing information · cbc31ab1-a80f-4b50-a3b1-39910b0fb609 · read 2026-08-30
On older people, the label states: “Across clinical studies used to establish the effectiveness of Tyvaso in patients with PAH and PH-ILD, 268 (47.8%) patients aged 65 years and over were enrolled.”
US prescribing information · cbc31ab1-a80f-4b50-a3b1-39910b0fb609 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Limited case reports of treprostinil use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes.”
US prescribing information · cbc31ab1-a80f-4b50-a3b1-39910b0fb609 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of treprostinil in human milk, the effects on the breastfed infant, or the effects on milk production.”
US prescribing information · cbc31ab1-a80f-4b50-a3b1-39910b0fb609 · read 2026-08-30
Where the result stopped carrying
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
A different form was studied
The studied form is not the form on the shelf.
On this record: This record is linked to 1 related forms. Evidence does not carry across all of them.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (10)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Given by a clinician
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Intravenous, subcutaneous
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
RNAWiki has not recorded a supervision or regulatory status for this substance.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
No register row and no identity class settled the question.
No source is stored against this line.
What is in the pack
Sold as injectable, solution, powder, tablet, extended release, given by the intravenous, subcutaneous, inhalation, oral route.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take∅Nothing found in the sources checked
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Intravenous, subcutaneous
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
54 products list this as an active ingredient in the United States drug directory. 54 of them contain it and nothing else.
FDA National Drug Code directory · 66302-300 · read 2026-08-29
They are sold as capsule, inhalant, injection, injection, solution, powder and tablet, extended release, taken intravenous, oral, respiratory (inhalation) and subcutaneous.
FDA National Drug Code directory · 66302-300 · read 2026-08-29
The regulator's established pharmacologic class for it is prostacycline vasodilator [epc], prostaglandins i [cs] and vasodilation [pe].
FDA National Drug Code directory · 66302-300 · read 2026-08-29
9 published labels name it as an active ingredient. 6 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 33050ee2-519b-1f0b-d4df-9e14dd329c57 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 33050ee2-519b-1f0b-d4df-9e14dd329c57 · read 2026-08-29
TYVASO is oral at 3 DOSAGE FORMS AND STRENGTHS Sterile solution for oral inhalation: 2.9 mL ampule containing 1.74 mg of treprostinil (0.6 mg per mL)., recorded as fda label in effect 2026-04-14 in the United States.
US prescribing information · cbc31ab1-a80f-4b50-a3b1-39910b0fb609 · read 2026-08-30
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
This order is fixed in code and does not count clicks or time on the page.
What is not here
9 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
What was measured, goal by goal — found nothing in the sources checked.
How close this is to real life — found nothing in the sources checked.
The path through the body — found nothing in the sources checked.
Felt, measured, or meaningful — found nothing in the sources checked.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
Claims that go past the evidence — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
Recorded evidence blocks (8)
Q1
On the (3R)-TREPROSTINIL label: indicated for what?
"Tyvaso is a prostacyclin mimetic indicated for the treatment of: Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability.": indications and usage on (3R)-TREPROSTINIL's label. DailyMed label · cbc31ab1-a80f-4b50-a3b1-39910b0fb609 · 2026-04-14
Q2
71 registered trials of (3R)-TREPROSTINIL — at which phases?
Registered studies posting no result
40 of 71
71 registered studies of (3R)-TREPROSTINIL: 21 phase2, 18 phase3, 16 phase4, 11 phase1, 7 na or unstated, 2 early phase1, 2 na. CLINICALTRIALS_SNAPSHOT · 2026-09-01
"Study closed due to limited availability of eligible subjects and competition by for enrollment by other studies"; 19 of 71 registered studies
Show the evidence
Trial
NCT00439946
terminated; "Study closed due to limited availability of eligible subjects and competition by for enrollment by other studies"
NCT00458042
terminated; "Low Enrollment"
NCT00494533
terminated; "Safety issues related to outpatient intravenous infusion in India"
NCT00643604
terminated; "Due to availability of eligible subjects at center and enrollment competition with other studies."
NCT01980979
withdrawn; "slow enrollment"
NCT02178566
terminated; "Unable to enroll"
13 further recorded trials
NCT02261883
terminated; "Sponsor Decision"
NCT02498444
terminated; "Interim futility analysis"
NCT02603068
withdrawn; "Study design was inadequate and would not achieve study endpoints"
NCT02633293
terminated; "Inhaled treprostinil became commercially available in the US following its approval for PH-ILD"
NCT02769624
terminated; "Study was stopped early due to inability to recruit additional participants"
NCT02882126
withdrawn; "Business decision"
NCT02893995
withdrawn; "Business decision"
NCT02999906
withdrawn; "For business reasons."
NCT03012646
withdrawn; "Business decision"
NCT03016468
withdrawn; "Business decision"
NCT03037580
terminated; "Terminated by sponsor"
NCT03043651
terminated; "Terminated by Sponsor"
NCT03055234
withdrawn; "Business decision"
recorded 2026-09-01 · last checked 2026-09-04
Q4
(3R)-TREPROSTINIL's half-life is 4 hours — which schedules were studied?
4 hours, the half-life (3R)-TREPROSTINIL's label states: "The elimination of treprostinil (following subcutaneous administration of treprostinil) is biphasic, with a terminal elimination half-life of approximately 4 hours using a 2-compartment model." DailyMed label · cbc31ab1-a80f-4b50-a3b1-39910b0fb609 · 2026-04-14
tmax 0.12 hr; bioavailability 64 %.
Show the evidence
half lifepharmacokinetics
4 hours; The elimination of treprostinil (following subcutaneous administration of treprostinil) is biphasic, with a terminal elimination half-life of approximately 4 hours using a 2-compartment model.
tmaxpharmacokinetics
0.12 hr; The mean C max at the target dose was 0.91 and 1.32 ng/mL with corresponding mean T max of 0.25 and 0.12 hr, respectively.
bioavailabilitypharmacokinetics
64 %; Mean estimates of the absolute systemic bioavailability of treprostinil after inhalation were approximately 64% (18 mcg) and 72% (36 mcg).
metabolismpharmacokinetics
Metabolism and Excretion Of subcutaneously administered treprostinil, only 4% is excreted unchanged in urine.
recorded 2026-04-14 · last checked 2026-09-04
Q5
Which running trial of (3R)-TREPROSTINIL could settle function?
NCT07736846 measures Mean Change From Baseline in 6-Minute Walk Distance at Month 12, reading out 2031-12.
1 open trial; n 300; "TREPROSTINIL in Pulmonary Hypertension: Evidence and Clinical Trends"
Show the evidence
TrialNCT07736846
"TREPROSTINIL in Pulmonary Hypertension: Evidence and Clinical Trends"; n 300; "Mean Change From Baseline in 6-Minute Walk Distance at Month 12"; 2031-12
Q6
Which 11 trials of (3R)-TREPROSTINIL posted no result?
Posted no result
11 of 11 completed trials
Registrations
NCT00058929, NCT00963027, NCT00963001, NCT01082484, NCT02318758 and NCT06193031, and 5 more
Completion dates
oldest 2005-08; newest 2021-12-31
Show the evidence
Trial
NCT00058929
2005-08
NCT00963027
2009-10
NCT00963001
2009-11
NCT01082484
2011-01
NCT02318758
2014-12
NCT06193031
2015-12-18
5 further recorded trials
NCT01758744
2016-07
NCT04675944
2018-05-25
NCT02865733
2019-08-20
NCT01481974
2019-11-24
NCT02583789
2021-12-31
Q7
At the median, (3R)-TREPROSTINIL's trials enrolled 29.5 people — anything larger?
Median enrolment
29.5
Largest enrolment
1850
Registered trials counted
70
Q8
(3R)-TREPROSTINIL and CYP2C8, CYTOCHROME P450 and CYP1A2: shared by which compounds?
7.3 Effect of Cytochrome P450 Inhibitors and Inducers In vitro studies of human hepatic microsomes showed that treprostinil does not inhibit cytochrome P450 (CYP) isoenzymes CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A.
drug_interactions
Additionally, treprostinil does not induce cytochrome P450 isoenzymes CYP1A2, CYP2B6, CYP2C9, CYP2C19, and CYP3A.
drug_interactions
Human pharmacokinetic studies with an oral formulation of treprostinil (treprostinil diolamine) indicated that co-administration of the cytochrome P450 (CYP) 2C8 enzyme inhibitor, gemfibrozil, increases exposure (both C max and AUC) to treprostinil.
drug_interactions
Co-administration of the CYP2C8 enzyme inducer, rifampin, decreases exposure to treprostinil.
drug_interactions
It is unclear if the safety and efficacy of treprostinil by the inhalation route are altered by inhibitors or inducers of CYP2C8 [see Warnings and Precautions (5.3) ] .
pharmacokinetics
Treprostinil is substantially metabolized by the liver, primarily by CYP2C8.
1 more recorded row
Interaction statementclinical_pharmacology
Treprostinil is substantially metabolized by the liver, primarily by CYP2C8.
ClinicalTrials.gov — US Government work · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
✗ required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 4 source rows
✓ no critical contamination: no quarantine open
✓ canonical metadata passed: slug and display name present
✓ no raw internal fields: enforced by the copy-contract test over the rendered page
This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.