Wednesday, July 8, 2026

Drug profile · INN

treprostinil diolamine

treprostinil diolamine (OREPAXAM) is a prostanoid ip receptor agonist. Associated with United Therapeutics Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: application withdrawn Blood and blood forming organs (B01) B01AC21
US status approved
Patents linked 9
Pipeline programs 1
News articles 0
Drug details — treprostinil diolamine
US status
approved
Class
Blood and blood forming organs (B01)
Route
ORAL
Patents
9
Programs
1
Data quality
0.89

Quick answer

treprostinil diolamine (OREPAXAM) is a prostanoid ip receptor agonist. Associated with United Therapeutics Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN treprostinil diolamine
Brand OREPAXAM
Mechanism Prostanoid IP receptor agonist
Target Prostacyclin receptor
Therapeutic class Blood and blood forming organs (B01)
Route ORAL
Formulation TABLET, EXTENDED RELEASE
ATC code B01AC21

Mechanism of action

Prostanoid IP receptor agonist

Primary target: Prostacyclin receptor

Approval history

Authority Status Date
FDA approved
EMA application withdrawn

Pipeline programs

  1. UT-15C (treprostinil diolamine) Phase 3 · United Therapeutics Europe · Pulmonary Arterial Hypertension

Related & competitor drugs

  1. apixaban Blood and blood forming organs (B01)
  2. berotralstat Blood and blood forming organs (B06)
  3. bivalirudin Blood and blood forming organs (B01)
  4. c1 inhibitor (human) Blood and blood forming organs (B06)
  5. clopidogrel Blood and blood forming organs (B01)
  6. dabigatran etexilate Blood and blood forming organs (B01)
  1. US 11723887

    Process to prepare treprostinil, the active ingredient in Remodulin®

    Expires Mon Aug 10 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 9604901

    Process to prepare treprostinil, the active ingredient in Remodulin®

    Expires Mon Mar 23 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 9593066

    Process to prepare treprostinil, the active ingredient in remodulin®

    Expires Mon Mar 09 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 9393203

    Osmotic drug delivery system

    Expires Mon Jul 14 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 8747897

    Osmotic drug delivery system

    Expires Mon Jun 05 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 8497393

    Process to prepare treprostinil, the active ingredient in Remodulin®

    Expires Mon Jul 25 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 8410169

    Compounds and methods for delivery of prostacyclin analogs

    Expires Mon Mar 28 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 8349892

    Solid formulations of prostacyclin analogs

    Expires Mon Jan 03 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 7417070

    Compounds and methods for delivery of prostacyclin analogs

    Expires Mon Aug 21 2028 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is treprostinil diolamine?

treprostinil diolamine (OREPAXAM) is a prostanoid ip receptor agonist. Associated with United Therapeutics Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for treprostinil diolamine?

OREPAXAM is a marketed brand name for treprostinil diolamine. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of treprostinil diolamine?

treprostinil diolamine has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.