Drugs / Rinvecalinase Alfa
Rinvecalinase Alfa
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | cerebral artery occlusion | 2023-06-21 | “On June 21, 2023, the Company announced that the U.S. Food and Drug Administration (FDA) fully lifted the clinical hold” diamedica.com ↗ |
| Filed | US (FDA) | — | cerebral artery occlusion | 2021-05-05 | “DiaMedica has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA)” diamedica.com ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03795389 | Feb → Jul 2019 | chronic kidney disease, diabetes mellitus | DiaMedica Therapeutics Inc | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01845064 | Apr 2013 → Sep 2014 | type 2 diabetes mellitus | DiaMedica Therapeutics Inc | Completed | No outcome recorded |
| Phase 22 trials · 2 met primary | ||||||
| Phase 2 | NCT04123613 | Dec 2019 → Mar 2022 | kidney disorder | DiaMedica Therapeutics Inc | Completed | Met primary |
| Phase 2 | NCT03290560 | Jan 2018 → Jan 2020 | ischemic stroke | DiaMedica Therapeutics Inc | Completed | Met primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05065216 | Nov 2021 → Dec 2026 expected | ischemic stroke | DiaMedica Therapeutics Inc | Recruiting | No outcome recorded |
| Phase not applicable1 trial · 1 met primary | ||||||
| — | NCT06875141 | May 2025 | preeclampsia | DiaMedica Therapeutics Inc | Withdrawn | Met primary |
News releases announcing trial results or a regulatory action · 21
| Date | Issuer | Release |
|---|---|---|
| 2026-03-05 | DiaMedica Therapeutics Inc | Regulatory DiaMedica Therapeutics Receives Health Canada Clearance to Initiate Phase 2 Study of DM199 in Preeclampsia diamedica.com ↗
DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for preeclampsia, fetal growth restriction and acute ischemic stroke (AIS), today announced that it has received a No Objection Letter (NOL) from Health Canada for its Clinical Trial Application to evaluate DM199 in a Phase 2 trial in patients with early-onset preeclampsia (PE). |
| 2025-12-18 | DiaMedica Therapeutics Inc | Results DiaMedica Therapeutics Provides DM199 Preeclampsia Program Update Following Pre-IND Meeting with FDA diamedica.com ↗ |
| 2025-07-17 | DiaMedica Therapeutics Inc | Results DiaMedica Therapeutics Reports Positive Interim Phase 2 Preeclampsia Results: Statistically Significant Reductions in Blood Pressure and No Placental Transfer diamedica.com ↗
DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company, today announced positive interim results from Part 1a of the Phase 2 study of DM199 for the treatment of preeclampsia. |
| 2024-11-13 | DiaMedica Therapeutics Inc | Regulatory DiaMedica Therapeutics Provides a Business Update and Announces Third Quarter 2024 Financial Results diamedica.com ↗ |
| 2024-10-09 | DiaMedica Therapeutics Inc | Regulatory DiaMedica Therapeutics Announces Regulatory Approval to Begin Phase 2 Trial of DM199 in the Treatment of Preeclampsia diamedica.com ↗ |
| 2023-06-21 | DiaMedica Therapeutics Inc | Regulatory DiaMedica Therapeutics Announces that the FDA Has Removed The Clinical Hold On DM199 Phase 2/3 Trial For Ischemic Stroke diamedica.com ↗
We are pleased that the FDA has fully lifted the clinical hold. |
| 2023-05-15 | DiaMedica Therapeutics Inc | Results DiaMedica Therapeutics Provides a Business Update and Announces First Quarter 2023 Financial Results diamedica.com ↗
DiaMedica has completed supplemental in-use studies as requested by the FDA. |
| 2022-10-26 | DiaMedica Therapeutics Inc | Regulatory DiaMedica Therapeutics Provides Update on ReMEDy2 Trial diamedica.com ↗
The FDA stated it is maintaining its clinical hold at this time and that additional non-clinical data related to the materials used by a hospital in the IV infusion process is needed to resolve the clinical hold. |
| 2022-07-06 | DiaMedica Therapeutics Inc | Regulatory DiaMedica Therapeutics Announces Clinical Hold of its Phase 2/3 ReMEDy2 Clinical Trial for DM199 diamedica.com ↗
DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on the Company’s Phase 2/3 ReMEDy2 trial studying the use of the Company’s product candidate, DM199, to treat acute ischemic stroke (AIS) patients. |
| 2021-11-08 | DiaMedica Therapeutics Inc | Regulatory DiaMedica Therapeutics Announces Addition of Stroke Recurrence as a Second Independent Primary Endpoint in ReMEDy2 Phase 2/3 AIS Trial diamedica.com ↗
The FDA’s acceptance of the amendment allows the Company to evaluate the effects of DM199 on both physical recoveries post AIS and the rate of recurrent AIS, as two separate independent primary endpoints, with each statistically powered for success. |
| 2021-09-30 | DiaMedica Therapeutics Inc | Regulatory DiaMedica Therapeutics Announces Fast Track Designation Granted to DM199 for the Treatment of Acute Ischemic Stroke diamedica.com ↗
DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track Designation to the Company’s lead candidate DM199 for the treatment of acute ischemic stroke (AIS) where tissue plasminogen activator and/or mechanical thrombectomy are not indicated or medically appropriate. |
| 2021-06-29 | DiaMedica Therapeutics Inc | Results DiaMedica Therapeutics Announces Positive Interim Results from Phase 2 REDUX Study in CKD diamedica.com ↗
DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and cardio-renal diseases, today announced positive interim results from its Phase 2 REDUX trial of DM199 in chronic kidney disease (CKD). |
| 2021-05-17 | DiaMedica Therapeutics Inc | Regulatory DiaMedica Therapeutics Announces FDA Clearance of IND Application to Initiate Phase 2/3 Clinical Trial for DM199 for Acute Ischemic Stroke diamedica.com ↗
DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical Company focused on developing novel treatments for neurological disorders and kidney diseases, announced today that the U.S. Food & Drug Administration (FDA) has accepted the Company’s Investigational New Drug (IND) application. |
| 2021-05-05 | DiaMedica Therapeutics Inc | Regulatory DiaMedica Therapeutics Provides a Business Update and Announces First Quarter 2021 Financial Results diamedica.com ↗
DiaMedica has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for an adaptive Phase 2/3 clinical trial of DM199, the Company’s recombinant form of human tissue kallikrein-1 being developed as a treatment for acute ischemic stroke (AIS) patients. |
| 2020-05-13 | DiaMedica Therapeutics Inc | Results DiaMedica Announces Positive Results in Top-Line Data From the Phase II ReMEDy Acute Ischemic Stroke Study diamedica.com ↗
Further, no DM199-related serious adverse events were noted in the study. |
| 2020-05-13 | DiaMedica Therapeutics Inc | Results DiaMedica Announces Positive Results in Top-Line Data from the Phase II ReMEDy Acute Ischemic Stroke Study and Provides a Business Update and First Quarter 2020 Financial Results diamedica.com ↗
DiaMedica today announced positive top-line results from its ReMEDy trial, a Phase II study assessing the safety, tolerability and therapeutic potential of DM199 in participants suffering from AIS. |
| 2020-03-26 | DiaMedica Therapeutics Inc | Results DiaMedica Therapeutics to Present Research at National Kidney Foundation 2020 Spring Clinical Meetings Live Virtual Conference diamedica.com ↗
DiaMedica’s poster presents the results of a Phase Ib study conducted to investigate the dosage required to restore normal KLK1 protein levels in subjects with moderate and severe chronic kidney disease (CKD) caused by Type I or II diabetes. |
| 2019-10-14 | DiaMedica Therapeutics Inc | Regulatory DiaMedica Therapeutics Announces Clearance to Initiate Phase II Clinical Trial of DM199 for Chronic Kidney Disease diamedica.com ↗ |
| 2019-06-19 | DiaMedica Therapeutics Inc | Results DiaMedica Therapeutics Announces Interim Results from Phase 1b Trial of DM199 in Chronic Kidney Disease Participants diamedica.com ↗
DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biotechnology company, today announced interim results of the Phase 1b study from 28 evaluable participants with moderate and severe chronic kidney disease (CKD). |
| 2019-02-14 | DiaMedica Therapeutics Inc | Regulatory DiaMedica Therapeutics Doses First Patient in Phase 1b Clinical Study of DM199 in Patients with Chronic Kidney Disease diamedica.com ↗
DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biotechnology company, today announced that it has initiated dosing patients with chronic kidney disease (“CKD”) in a Phase Ib clinical study evaluating DM199. |
| 2019-01-03 | DiaMedica Therapeutics Inc | Regulatory DiaMedica Announces FDA Clearance of IND Application To Study DM199 in Patients with Chronic Kidney Disease diamedica.com ↗
DiaMedica Therapeutics Inc. (“DiaMedica”) (NASDAQ:DMAC) (TSX-V:DMA) announced today that the U.S. Food and Drug Administration ("FDA") has accepted DiaMedica’s Investigational New Drug application ("IND") for the initiation of a Phase Ib clinical trial of DM199 in patients with moderate or severe Chronic Kidney Disease (“CKD”) caused by Type I or Type II diabetes. |
All press releases naming this drug 36 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | rinvecalinase alfa | “This is a Phase 2/3 study evaluating the safety and efficacy of DM199 (rinvecalinase alfa) in treating participants with moderate stroke severity” NCT05065216 ↗1“Safety and tolerability of Rinvecalinase Alfa (DM199) for acute ischemic stroke” PMID 41195862 ↗ Nov 2025 |
| Known as | DM199 | “This is a Phase 2/3 study evaluating the safety and efficacy of DM199 (rinvecalinase alfa) in treating participants with moderate stroke severity” NCT05065216 ↗ |
| Known as | Rinvecalinasa alfa | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314769 ↗ |
| Modality | Protein / enzyme biologic | “DM199 (recombinant human tissue kallikrein-1) is being developed as a new biological treatment for type 2 diabetes mellitus.” NCT01845064 ↗ |
| Route | Subcutaneous | “Subjects will receive DM199 subcutaneously (sc).” NCT01845064 ↗ |