Drugs / Relmapirazin
Relmapirazin
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT04008121 | Nov 2025 → Dec 2026 expected | diabetic retinopathy, macular degeneration, retinal vein occlusion | MediBeacon | Recruiting | No outcome recorded |
| Phase 0 | NCT03962998 | Oct 2019 → Oct 2021 | small bowel Crohn disease | MediBeacon | Completed | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT07080008 | Jan → Dec 2026 expected | ureteral disorder | MediBeacon | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04109482 | Feb 2020 → May 2023 | CD4+/CD56+ hematodermic neoplasm | Mustang Bio | Terminated | No outcome recorded Stop: Business |
| Phase 21 trial | ||||||
| Phase 2 | NCT02772276 | May 2016 → Aug 2021 | acute kidney injury | MediBeacon | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT05777174 | Mar 2023 → Apr 2024 | kidney failure | MediBeacon | Completed | No outcome recorded |
| Phase 3 | NCT05425719 | Jun 2022 → Feb 2023 | chronic kidney disease | MediBeacon | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 4 | NCT07643467 Background | Sep 2026 → May 2028 expected | — | Aaron Cook | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2025-12-16 | MediBeacon | Regulatory MediBeacon® Next Generation TGFR™ System Receives FDA Approval medibeacon.com ↗
MediBeacon® Next Generation TGFR™ System Receives FDA Approval |
| 2025-10-31 | MediBeacon | Results MediBeacon<sup>®</sup> to Present at the Upcoming American Society of Nephrology (ASN) Kidney Week 2025 medibeacon.com ↗ |
| 2025-10-21 | MediBeacon | Regulatory MediBeacon<sup>®</sup> receives regulatory approval to sell the Transdermal GFR System in China medibeacon.com ↗
MediBeacon’s Lumitrace® (relmapirazin) injection, a non-radioactive, non-iodinated fluorescent GFR agent, has been approved by the National Medical Products Administration (NMPA). |
| 2025-01-18 | MediBeacon | Regulatory MediBeacon<sup>®</sup> Transdermal GFR System Receives FDA Approval to Assess Kidney Function medibeacon.com ↗
MediBeacon Inc. today announced the U.S. Food and Drug Administration (FDA) has approved the MediBeacon® TGFR for the assessment of kidney function in patients with normal or impaired renal function. |
| 2019-08-05 | Mustang Bio, Inc. | Regulatory FDA Clears IND for Mustang Bio’s MB-102 (CD123 CAR T) mustangbio.com ↗ |
| 2019-07-24 | Mustang Bio, Inc. | Regulatory Mustang Bio Receives Orphan Drug Designation for MB-102 (CD123 CAR T) for the Treatment of Acute Myeloid Leukemia mustangbio.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to MB-102 (CD123 CAR T) for the treatment of acute myeloid leukemia (AML). |
| 2018-12-20 | Mustang Bio, Inc. | Regulatory Mustang Bio Receives Orphan Drug Designation for MB-102 (CD123 CAR T) for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm mustangbio.com ↗
Mustang Bio, Inc. (“Mustang”) (NASDAQ: MBIO), a company focused on the development of novel immunotherapies based on proprietary chimeric antigen receptor engineered T cell (CAR T) technology and gene therapies for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to MB-102 (CD123 CAR T) for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare and incurable blood cancer with a median survival of less than 18 months and no standard of care. |
| 2018-10-22 | MediBeacon | Regulatory FDA Grants Breakthrough Device Status for MediBeacon’s Transdermal GFR Measurement System medibeacon.com ↗
MediBeacon Inc., whose largest shareholder is Pansend Life Sciences of HC2 Holdings, Inc. (NYSE MKT: HCHC), announced today the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to the company’s Transdermal GFR Measurement System (TGFR). |
| 2017-12-11 | Mustang Bio, Inc. | Results Mustang Bio's MB-102 (CD123 CAR) CAR T Therapy Achieves Complete Response in Acute Myeloid Leukemia and Blastic Plasmacytoid Dendritic Cell Neoplasm in Phase 1 Clinical Trial mustangbio.com ↗
According to investigators at City of Hope, these data demonstrate MB-102’s potential to be a safe, well tolerated and effective CAR T therapy that can achieve complete disease response. |
All press releases naming this drug 13 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Relmapirazin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07643467 ↗ |
| Known as | Lumitrace | “IV push of relmapirazin (Lumitrace) prior to use of the tGFR device” NCT07643467 ↗ |
| Known as | MB-102 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03962998 ↗ |
| Known as | Relmapirazina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1949708 ↗ |
| Known as | Relmapirazine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1949708 ↗ |
| Modality | Diagnostic / imaging agent | “fluorescent GFR tracer agent relmapirazin” PMID 39918882 ↗ Feb 2025 |
| Route | Intravenous | “4 µmol/kg administered by intravenous injection over 30 seconds” NCT02772276 ↗ |