deltatrials
Enrolling By Invitation PHASE3 INTERVENTIONAL 1-arm NCT03683186

A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension

A Phase 3 Open-label Extension (OLE) Study to Evaluate the Long-term Safety and Efficacy of Ralinepag in Subjects With World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH)

Sponsor: United Therapeutics

Conditions Cardiovascular Diseases Connective Tissue Diseases Familial Primary Pulmonary Hypertension Hypertension Hypertension, Pulmonary Lung Diseases PAH Pulmonary Arterial Hypertension Pulmonary Hypertension Respiratory Tract Disease Vascular Diseases
Interventions Ralinepag
Updated 54 times since 2018 Last updated: Feb 19, 2026 Started: Sep 23, 2019 Primary completion: Dec 31, 2026 Completion: Dec 31, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03683186, this PHASE3 trial focuses on Cardiovascular Diseases and Connective Tissue Diseases and remains ongoing. Sponsored by United Therapeutics, it has been updated 54 times since 2019, reflecting substantial change activity. This study contributes longitudinal data to the cardiovascular research landscape.

Status Flow

~Oct 2018 – ~May 2019 · 7 months · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Sep 2019 · 2 months · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Jan 2020 · 2 months · monthly snapshot~Jan 2020 – ~Mar 2020 · 2 months · monthly snapshot~Mar 2020 – ~Apr 2020 · 31 days · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Jun 2020 · 31 days · monthly snapshot~Jun 2020 – ~Jul 2020 · 30 days · monthly snapshot~Jul 2020 – ~Aug 2020 · 31 days · monthly snapshot~Aug 2020 – ~Sep 2020 · 31 days · monthly snapshot~Sep 2020 – ~Oct 2020 · 30 days · monthly snapshot~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshot~Nov 2020 – ~Dec 2020 · 30 days · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Apr 2021 · 3 months · monthly snapshot~Apr 2021 – ~Jun 2021 · 2 months · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Nov 2021 · 31 days · monthly snapshot~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshot~Dec 2021 – ~Mar 2022 · 3 months · monthly snapshot~Mar 2022 – ~Apr 2022 · 31 days · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Jan 2023 · 2 months · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Apr 2023 · 59 days · monthly snapshot~Apr 2023 – ~May 2023 · 30 days · monthly snapshot~May 2023 – ~Jun 2023 · 31 days · monthly snapshot~Jun 2023 – ~Jul 2023 · 30 days · monthly snapshot~Jul 2023 – ~Oct 2023 · 3 months · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~Dec 2023 · 30 days · monthly snapshot~Dec 2023 – ~Feb 2024 · 2 months · monthly snapshot~Feb 2024 – ~Mar 2024 · 29 days · monthly snapshot~Mar 2024 – ~Apr 2024 · 31 days · monthly snapshot~Apr 2024 – ~May 2024 · 30 days · monthly snapshot~May 2024 – ~Jun 2024 · 31 days · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~May 2025 · 7 months · monthly snapshot~May 2025 – ~Sep 2025 · 4 months · monthly snapshot~Sep 2025 – ~Dec 2025 · 3 months · monthly snapshot~Dec 2025 – ~Feb 2026 · 2 months · monthly snapshot~Feb 2026 – present · 4 months · monthly snapshot

Change History

54 versions recorded

  1. Feb 2026 — Present [monthly]

    Enrolling By Invitation PHASE3

  2. Dec 2025 — Feb 2026 [monthly]

    Enrolling By Invitation PHASE3

  3. Sep 2025 — Dec 2025 [monthly]

    Enrolling By Invitation PHASE3

  4. May 2025 — Sep 2025 [monthly]

    Enrolling By Invitation PHASE3

  5. Oct 2024 — May 2025 [monthly]

    Enrolling By Invitation PHASE3

▶ Show 49 earlier versions

  1. Sep 2024 — Oct 2024 [monthly]

    Enrolling By Invitation PHASE3

  2. Aug 2024 — Sep 2024 [monthly]

    Enrolling By Invitation PHASE3

  3. Jul 2024 — Aug 2024 [monthly]

    Enrolling By Invitation PHASE3

  4. Jun 2024 — Jul 2024 [monthly]

    Enrolling By Invitation PHASE3

  5. May 2024 — Jun 2024 [monthly]

    Enrolling By Invitation PHASE3

  6. Apr 2024 — May 2024 [monthly]

    Enrolling By Invitation PHASE3

  7. Mar 2024 — Apr 2024 [monthly]

    Enrolling By Invitation PHASE3

  8. Feb 2024 — Mar 2024 [monthly]

    Enrolling By Invitation PHASE3

  9. Dec 2023 — Feb 2024 [monthly]

    Enrolling By Invitation PHASE3

  10. Nov 2023 — Dec 2023 [monthly]

    Enrolling By Invitation PHASE3

  11. Oct 2023 — Nov 2023 [monthly]

    Enrolling By Invitation PHASE3

  12. Jul 2023 — Oct 2023 [monthly]

    Enrolling By Invitation PHASE3

  13. Jun 2023 — Jul 2023 [monthly]

    Enrolling By Invitation PHASE3

  14. May 2023 — Jun 2023 [monthly]

    Enrolling By Invitation PHASE3

  15. Apr 2023 — May 2023 [monthly]

    Enrolling By Invitation PHASE3

  16. Feb 2023 — Apr 2023 [monthly]

    Enrolling By Invitation PHASE3

  17. Jan 2023 — Feb 2023 [monthly]

    Enrolling By Invitation PHASE3

  18. Nov 2022 — Jan 2023 [monthly]

    Enrolling By Invitation PHASE3

  19. Sep 2022 — Nov 2022 [monthly]

    Enrolling By Invitation PHASE3

  20. Jul 2022 — Sep 2022 [monthly]

    Enrolling By Invitation PHASE3

  21. Jun 2022 — Jul 2022 [monthly]

    Enrolling By Invitation PHASE3

  22. May 2022 — Jun 2022 [monthly]

    Enrolling By Invitation PHASE3

  23. Apr 2022 — May 2022 [monthly]

    Enrolling By Invitation PHASE3

  24. Mar 2022 — Apr 2022 [monthly]

    Enrolling By Invitation PHASE3

  25. Dec 2021 — Mar 2022 [monthly]

    Enrolling By Invitation PHASE3

  26. Nov 2021 — Dec 2021 [monthly]

    Enrolling By Invitation PHASE3

  27. Oct 2021 — Nov 2021 [monthly]

    Enrolling By Invitation PHASE3

  28. Sep 2021 — Oct 2021 [monthly]

    Enrolling By Invitation PHASE3

  29. Jun 2021 — Sep 2021 [monthly]

    Enrolling By Invitation PHASE3

  30. Apr 2021 — Jun 2021 [monthly]

    Enrolling By Invitation PHASE3

  31. Jan 2021 — Apr 2021 [monthly]

    Enrolling By Invitation PHASE3

  32. Dec 2020 — Jan 2021 [monthly]

    Enrolling By Invitation PHASE3

  33. Nov 2020 — Dec 2020 [monthly]

    Enrolling By Invitation PHASE3

  34. Oct 2020 — Nov 2020 [monthly]

    Enrolling By Invitation PHASE3

  35. Sep 2020 — Oct 2020 [monthly]

    Enrolling By Invitation PHASE3

  36. Aug 2020 — Sep 2020 [monthly]

    Enrolling By Invitation PHASE3

  37. Jul 2020 — Aug 2020 [monthly]

    Enrolling By Invitation PHASE3

  38. Jun 2020 — Jul 2020 [monthly]

    Enrolling By Invitation PHASE3

  39. May 2020 — Jun 2020 [monthly]

    Enrolling By Invitation PHASE3

  40. Apr 2020 — May 2020 [monthly]

    Enrolling By Invitation PHASE3

  41. Mar 2020 — Apr 2020 [monthly]

    Enrolling By Invitation PHASE3

  42. Jan 2020 — Mar 2020 [monthly]

    Enrolling By Invitation PHASE3

  43. Nov 2019 — Jan 2020 [monthly]

    Enrolling By Invitation PHASE3

  44. Oct 2019 — Nov 2019 [monthly]

    Enrolling By Invitation PHASE3

  45. Sep 2019 — Oct 2019 [monthly]

    Enrolling By Invitation PHASE3

  46. Jul 2019 — Sep 2019 [monthly]

    Enrolling By Invitation PHASE3

  47. Jun 2019 — Jul 2019 [monthly]

    Enrolling By Invitation PHASE3

  48. May 2019 — Jun 2019 [monthly]

    Enrolling By Invitation PHASE3

  49. Oct 2018 — May 2019 [monthly]

    Enrolling By Invitation PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • United Therapeutics
Data source: United Therapeutics

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aarhus, Denmark , Adana, Turkey (Türkiye) , Albuquerque, United States , Alexandroupoli, Greece , Almada, Portugal , Amsterdam, Netherlands , Ankara, Turkey (Türkiye) , Athens, Greece , Atlanta, United States , Aurora, United States and 154 more locations