drugset
Drugs / RGI-2001
last change Oct 2025 re-read 3 minutes ago

RGI-2001

Other / unclassified targets CD1D via activation

Developed for
graft versus host disease · acute graft versus host disease
Investigated by
Regimmune Corporation · Zachariah Michael DeFilipp

Trials 3

today NCT04473911 · Ph 1 NCT04014790 · Ph 2 NCT01379209 · Ph 1/2
2012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT04473911 Aug 2020 → Oct 2023 Hodgkins lymphoma, acute lymphoblastic leukemia, acute myeloid leukemia, bone marrow failure syndrome +3 Zachariah Michael DeFilipp Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT01379209 Sep 2011 → Jun 2015 graft versus host disease Regimmune Corporation Completed No outcome recorded
Phase 21 trial
Phase 2 NCT04014790 Nov 2019 → Jul 2022 acute graft versus host disease Regimmune Corporation Completed No outcome recorded

Press releases naming this drug 8 releases

DateIssuerRelease
2024-04-15 Regimmune Corporation REGiMMUNE Announces the Poster Presentation at the AACR 2024 Annual Meeting for RGI-2001 Phase 2b latest analyses. regimmune.com ↗
2024-03-01 Regimmune Corporation Tandem 2024: REGiMMUNE’s RGI-2001 Demonstrates Higher acute GFS without Increased Relapse from the Phase 2b Study regimmune.com ↗
2023-12-27 Regimmune Corporation REGiMMUNE to Present Results from the Phase 2b Study of RGI-2001 at the 2024 Tandem Meeting regimmune.com ↗
2023-03-30 Regimmune Corporation REGiMMUNE Licenses The Rights to Develop and Commercialize RGI-2001 To San Fu Biotech in Major Asian Countries regimmune.com ↗
2022-12-19 Regimmune Corporation REGiMMUNE Presented Positive Results of RGI-2001 in the Reduction of Acute GvHD from Phase 2b Study at the 2022 ASH annual meeting regimmune.com ↗
2022-11-07 Regimmune Corporation REGiMMUNE to Present Results from the Phase 2b Study of RGI-2001 at the 2022 ASH Annual Meeting regimmune.com ↗
2012-11-14 Regimmune Corporation RGI-2001 was granted Orphan Drug Designation from FDA regimmune.com ↗
2012-11-14 Regimmune Corporation RGI-2001 was granted Orphan Drug Designation from FDA regimmune.com ↗

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 4 sources stand behind the page.

FieldValueCited text
Known as RGI-2001 ClinicalTrials.gov intervention name — accepted as the source's own label NCT01379209 ↗
2

NCT04473911 ↗

NCT04014790 ↗
Action Activate “can activate invariant natural killer T (NKT) cells” PMID 40680268 ↗ Oct 2025
Modality Other / unclassified “RGI-2001, a glycolipid” PMID 40680268 ↗ Oct 2025
Route Intravenous “single intravenous administration of RGI-2001” NCT01379209 ↗
Target CD1D “binds CD1d receptor” PMID 40680268 ↗ Oct 2025