DiaMedica Therapeutics' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by DiaMedica Therapeutics (DMAC).
Over the past two years, DiaMedica Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
DM199. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
DM199 FDA Regulatory Timeline and Events
DM199 is a drug developed by DiaMedica Therapeutics for the following indication: Chronic Kidney Disease Stage II or III.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- DM199
- Announced Date:
- September 30, 2026
- Indication:
- Chronic Kidney Disease Stage II or III
Announcement
DiaMedica Therapeutics Inc announced that it will host a virtual key opinion leader (KOL) event on October 23, 2026 at 8:00am Eastern Time to discuss fetal growth restriction (FGR), the therapeutic rationale for evaluating DM199 (rinvecalinase alfa) as a potential treatment for FGR and preliminary, interim topline results from the first cohort of an investigator-sponsored Phase 2 early-onset FGR trial.
Read Announcement- Drug:
- DM199
- Announced Date:
- June 23, 2026
- Indication:
- Chronic Kidney Disease Stage II or III
Announcement
DiaMedica Therapeutics Inc announced the dosing of the first two patients in an investigator-sponsored Phase 2 trial evaluating DM199 (rinvecalinase alfa) for the treatment of fetal growth restriction (FGR).
AI Summary
DiaMedica Therapeutics Inc. said the first two patients have been dosed in an investigator-sponsored Phase 2 trial of DM199, also called rinvecalinase alfa, for fetal growth restriction (FGR). FGR is a condition where a baby does not grow as expected during pregnancy, which can raise health risks for both the mother and baby.
The study will test whether DM199 can help improve blood flow and support better growth in babies affected by FGR. DM199 is a recombinant form of human tissue kallikrein-1, a protein being developed for several pregnancy- and circulation-related conditions. DiaMedica said the trial is an important step in learning more about the drug’s possible benefits in this serious condition.
The company is also studying DM199 in other clinical programs, but this update focused on the start of dosing in the Phase 2 FGR trial.
Read Announcement- Drug:
- DM199
- Announced Date:
- June 16, 2026
- Indication:
- Chronic Kidney Disease Stage II or III
Announcement
DiaMedica Therapeutics Inc. announced that it has received a written response from the U.S. Food and Drug Administration (FDA) regarding the need for additional nonclinical reproductive toxicity data to support continued development of DM199 (rinvecalinase alfa) for the treatment of preeclampsia (PE).
AI Summary
DiaMedica Therapeutics said the FDA asked for more nonclinical reproductive toxicity data before it can keep developing DM199, also called rinvecalinase alfa, for preeclampsia. In response, the company is starting a rat pharmacokinetic study to measure how the drug is absorbed and distributed, along with a pharmacologic activity study to show how DM199 works in this species. DiaMedica is also reviewing recently completed rat data that it believes will help support the drug’s activity.
After the rat PK study is finished, DiaMedica plans to send the new information to the FDA for review. The company said it hopes these studies will support a future U.S. IND filing for preeclampsia. DiaMedica also expects to begin its preeclampsia study in Canada and the United Kingdom later this year.
Read Announcement- Drug:
- DM199
- Announced Date:
- May 20, 2026
- Indication:
- Chronic Kidney Disease Stage II or III
Announcement
DiaMedica Therapeutics Inc announced that enrollment in its pivotal Phase 2/3 ReMEDy2 trial of DM199 (rinvecalinase alfa) in patients with acute ischemic stroke (AIS) has reached 75% of the 200-patient threshold required to trigger the planned interim analysis.
AI Summary
DiaMedica Therapeutics said enrollment in its pivotal Phase 2/3 ReMEDy2 trial of DM199, also called rinvecalinase alfa, has reached 75% of the 200-patient level needed to start a planned interim analysis. The study is testing DM199 in people with acute ischemic stroke, a serious type of stroke caused by blocked blood flow to the brain.
The interim review will be done by an independent Data Safety Monitoring Board. Its job is to decide whether the trial should be adjusted, including whether the sample size should be re-estimated. DiaMedica said this step is meant to help make sure the study has enough power to show success while protecting the trial’s integrity. The company will not see the detailed interim results.
DM199 is designed to improve blood flow and help protect brain tissue by acting on a natural human enzyme involved in circulation and inflammation.
Read Announcement- Drug:
- DM199
- Announced Date:
- March 5, 2026
- Indication:
- Chronic Kidney Disease Stage II or III
Announcement
DiaMedica Therapeutics In c nnounced 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).
AI Summary
DiaMedica Therapeutics Inc. announced it has received a No Objection Letter (NOL) from Health Canada for its Clinical Trial Application to study DM199 in a Phase 2 trial for patients with early-onset preeclampsia. The NOL clears the way for DiaMedica to initiate the Phase 2 study in Canada, advancing clinical evaluation of DM199—also known as rinvecalinase alfa—as a potential treatment for this serious pregnancy complication.
The company noted that its DM199 preeclampsia program recently received coverage on National Public Radio, raising public awareness. DiaMedica also included the usual cautionary language about forward-looking statements, reminding readers that trial timing and outcomes are subject to risks and uncertainties. The NOL represents a key regulatory step toward testing DM199’s safety and effectiveness in the targeted patient population.
Read Announcement- Drug:
- DM199
- Announced Date:
- December 18, 2025
- Indication:
- Chronic Kidney Disease Stage II or III
Announcement
DiaMedica Therapeutics Inc announced completion of a productive in-person pre-IND meeting with the United States Food and Drug Administration (FDA) for a planned study evaluating DM199 in preeclampsia.
AI Summary
DiaMedica announced it completed a productive in-person pre-IND meeting with the U.S. Food and Drug Administration about a planned study of DM199 for preeclampsia. Meeting minutes show the FDA requested one additional non-clinical study: a 10-day modified embryo-fetal development (EFD) and pre- and postnatal development (PPND) study in rabbits. DiaMedica has started preparations for that study and expects results by the second quarter of 2026. Company leadership said the meeting minutes give important regulatory clarity as they prepare an IND for a study in early-onset preeclampsia.
DiaMedica also said it will continue to engage with the FDA as it advances development of DM199. The company noted ongoing clinical work, including an investigator-sponsored Phase 2 trial that has dosed over 30 women with late-stage preeclampsia and shown encouraging safety and efficacy signals to date.
Read Announcement- Drug:
- DM199
- Announced Date:
- July 17, 2025
- Indication:
- Chronic Kidney Disease Stage II or III
Announcement
DiaMedica Therapeutics Inc. announced positive interim results from Part 1a of the Phase 2 study of DM199 for the treatment of preeclampsia.
AI Summary
DiaMedica Therapeutics Inc. announced positive interim results from Part 1a of its Phase 2 study evaluating DM199 for the treatment of preeclampsia. In the dose-escalation phase, DM199 showed highly statistically significant and clinically meaningful reductions in both systolic and diastolic blood pressure. In addition, the treatment significantly reduced the uterine artery pulsatility index, indicating improved placental perfusion. Most importantly, DM199 did not cross the placental barrier and was well tolerated, addressing a major safety concern in preeclampsia treatment.
These encouraging outcomes support DM199’s potential as a first-in-class, disease-modifying therapy for a condition with no approved pharmacological treatments in the United States and Europe. The positive safety and efficacy benchmarks meet key study endpoints and bolster further investigation into the drug's role in improving maternal and fetal health in this underserved patient population.
Read Announcement- Drug:
- DM199
- Announced Date:
- February 20, 2025
- Indication:
- Chronic Kidney Disease Stage II or III
Announcement
DiaMedica Therapeutics Inc announced the peer-reviewed publication entitled:Recombinant human tissue kallikrein-1 for treating acute ischemic stroke and preventing recurrence (Kasner, et al.) which is now available online and is scheduled for print publication in the February 2025 issue of Stroke.
AI Summary
DiaMedica Therapeutics Inc. announced that a new peer-reviewed article, "Recombinant human tissue kallikrein-1 for treating acute ischemic stroke and preventing recurrence" (Kasner et al.), is now available online and will appear in the February 2025 issue of Stroke. This publication explains how DM199, a recombinant form of human tissue kallikrein-1, works to treat acute ischemic stroke by increasing collateral circulation and protecting brain tissue.
The study shows that DM199 boosts the production of bradykinin, a substance that dilates blood vessels in the brain, enhancing blood flow and promoting the formation of new blood vessels, which may help repair injured tissue. These findings provide important scientific insight into DM199’s potential to improve outcomes in stroke patients by enhancing blood circulation in the affected brain regions, offering a novel approach to stroke treatment.
Read Announcement- Drug:
- DM199
- Announced Date:
- December 3, 2024
- Indication:
- Chronic Kidney Disease Stage II or III
Announcement
DiaMedica Therapeutics Inc announce the formation of its Scientific Advisory Board (SAB) to support the development of DM199, its proprietary recombinant serine protease, for the treatment of preeclampsia (PE).
AI Summary
DiaMedica Therapeutics Inc. announced the formation of its new Scientific Advisory Board (SAB) to help guide the development of DM199, a proprietary recombinant serine protease aimed at treating preeclampsia (PE). The SAB is made up of renowned experts in PE and maternal-fetal health who will work closely with DiaMedica’s leadership. Their expert guidance is expected to accelerate the research and clinical strategies needed to bring DM199 closer to providing a safe and effective treatment for this life-threatening condition.
Rick Pauls, President and CEO, highlighted his excitement for the collaboration, emphasizing that the insights from these distinguished doctors will play a key role in advancing care for women and their babies facing preeclampsia. This strategic move marks an important step forward in DiaMedica’s efforts to develop innovative treatments for serious pregnancy-related disorders.
Read Announcement- Drug:
- DM199
- Announced Date:
- October 9, 2024
- Target Action Date:
- Q4 2024
- Estimated Target Date Range:
- October 1, 2024 - December 31, 2024
- Indication:
- Chronic Kidney Disease Stage II or III
Announcement
DiaMedica Therapeutics announced that Dosing first participant expected in the fourth quarter of 2024 with preliminary proof-of-concept results targeted for the first half of 2025
AI Summary
DiaMedica Therapeutics announced that it is set to begin dosing the first participant in its Phase 2 clinical trial in the fourth quarter of 2024. This trial will focus on testing DM199, the company’s proprietary recombinant serine protease, to treat preeclampsia. The study aims to assess whether DM199 is safe and if it can effectively improve maternal blood pressure and placental blood flow.
Preliminary proof-of-concept results are expected to be available in the first half of 2025. These early findings will be crucial in determining the drug’s potential to offer a new treatment option for preeclampsia, a condition that poses significant risks to both mothers and their babies. The upcoming milestones mark important steps toward understanding and addressing this serious pregnancy disorder.
Read Announcement- Drug:
- DM199
- Announced Date:
- October 9, 2024
- Indication:
- Chronic Kidney Disease Stage II or III
Announcement
DiaMedica Therapeutics Inc announced regulatory approval has been received to initiate a Phase 2 clinical trial with DM199, its proprietary recombinant serine protease, for the treatment of preeclampsia.
AI Summary
DiaMedica Therapeutics Inc. announced that it has received regulatory approval from the South African Health Products Regulatory Authority to start a Phase 2 clinical trial using its proprietary recombinant serine protease, DM199, to treat preeclampsia. The trial will be conducted at Tygerberg Hospital in Cape Town under the direction of Professor Catherine Cluver, MD, PhD. Researchers will assess whether DM199 can safely lower maternal blood pressure, improve endothelial health, and increase placental blood flow, potentially leading to longer gestational periods and healthier outcomes for both mothers and babies.
Dosing of the first participant is scheduled to begin in the fourth quarter of 2024, with preliminary proof-of-concept results expected in the first half of 2025. This trial represents an important step toward developing the first targeted therapeutic option for preeclampsia.
Read Announcement
DiaMedica Therapeutics FDA Events - Frequently Asked Questions
As of now, DiaMedica Therapeutics (DMAC) has not received any FDA approvals for its therapy in the last two years.
In the past two years, DiaMedica Therapeutics (DMAC) has reported FDA regulatory activity for DM199.
The most recent FDA-related event for DiaMedica Therapeutics occurred on September 30, 2026, involving DM199. The update was categorized as "Provided Update," with the company reporting: "DiaMedica Therapeutics Inc announced that it will host a virtual key opinion leader (KOL) event on October 23, 2026 at 8:00am Eastern Time to discuss fetal growth restriction (FGR), the therapeutic rationale for evaluating DM199 (rinvecalinase alfa) as a potential treatment for FGR and preliminary, interim topline results from the first cohort of an investigator-sponsored Phase 2 early-onset FGR trial."
Currently, DiaMedica Therapeutics has one therapy (DM199) targeting the following condition: Chronic Kidney Disease Stage II or III.
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FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for NASDAQ:DMAC last updated on 9/30/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
