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:
- 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- Drug:
- DM199
- Announced Date:
- July 11, 2024
- Target Action Date:
- July 19, 2024
- 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 Monday, July 29, 2024, at 10:00 AM ET to provide further insight into the expansion of its clinical development program for DM199 (rinvecalinase alfa) into preeclampsia, a significant, unmet medical need with no FDA-approved therapeutics.
AI Summary
DiaMedica Therapeutics Inc. has announced a virtual key opinion leader (KOL) event on Monday, July 29, 2024, at 10:00 AM ET. The event will highlight the company’s plans to expand its clinical development program for DM199 (rinvecalinase alfa) into treating preeclampsia—a serious pregnancy disorder with no FDA-approved treatments.
The session will feature expert speakers who will discuss the urgent need for new therapies and explore how DM199 works. DM199 aims to improve blood flow and lower blood pressure by boosting the production of nitric oxide, prostacyclin, and other factors that support vascular health in both the mother and placenta. A live question and answer session will follow, offering attendees an opportunity to engage directly with the experts during the event.
Read Announcement- Drug:
- DM199
- Announced Date:
- June 26, 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 Inc announced that Preeclampsia Program to be Initiated with a Phase 2 Investigator-sponsored Trial Beginning in Q4 2024
AI Summary
DiaMedica Therapeutics Inc. announced it will initiate its Phase 2 investigator-sponsored trial for preeclampsia in the fourth quarter of 2024. The trial will study DM199, a recombinant human tissue kallikrein-1 protein, as a potential treatment to lower blood pressure and improve maternal blood flow through the placenta. This approach could address a life-threatening vascular disorder during pregnancy that currently has no approved therapeutics in the U.S. or Europe.
The study plans to enroll up to 120 participants, with preliminary proof-of-concept results expected by the first half of 2025. The trial is designed to assess safety, blood pressure reduction, and the drug’s ability to dilate intrauterine arteries without crossing the placental barrier, which could offer a significant safety advantage. The Phase 2 trial represents a key expansion of DiaMedica’s clinical development program in addressing a critical unmet medical need in pregnancy disorders.
Read Announcement- Drug:
- DM199
- Announced Date:
- June 26, 2024
- Target Action Date:
- H1 2025
- Estimated Target Date Range:
- January 1, 2025 - June 30, 2025
- Indication:
- Chronic Kidney Disease Stage II or III
Announcement
DiaMedica Therapeutics Inc. announced that Key Proof-of-Concept Results Expected in the First Half of 2025
AI Summary
DiaMedica Therapeutics Inc. announced plans for a Phase 2 investigator-sponsored trial to explore its novel treatment DM199 for preeclampsia. The study, which is set to begin enrolling participants in the fourth quarter of 2024, will evaluate DM199’s ability to safely lower blood pressure and improve blood flow to the placenta without crossing the placental barrier. The trial, conducted in South Africa at Tygerberg Hospital, is designed to be capital efficient by enrolling up to 120 participants. DiaMedica expects to generate key proof-of-concept results in the first half of 2025. These results will be critical in determining whether DM199 can provide a safe and effective treatment option for preeclampsia, a serious condition with significant risks to both mother and baby. This potential breakthrough could offer hope in an area where no FDA-approved therapies currently exist.
Read Announcement- Drug:
- DM199
- Announced Date:
- June 26, 2024
- Indication:
- Chronic Kidney Disease Stage II or III
Announcement
DiaMedica Therapeutics Inc. announced that it plans to expand its DM199 (rinvecalinase alfa; recombinant human tissue kallikrein-1 (rhKLK1)) clinical development program into preeclampsia.
AI Summary
DiaMedica Therapeutics Inc. announced plans to expand its DM199 clinical development program into preeclampsia, a serious pregnancy-related condition marked by high blood pressure and potential organ damage. DM199, a recombinant human tissue kallikrein-1 protein, has shown promise in lowering blood pressure and improving blood flow. Unlike small molecule anti-hypertensive drugs, DM199 is a large molecule that does not cross the placental barrier in animal studies, suggesting a safety advantage for pregnant women.
The company will launch a Phase 2 investigator-sponsored trial in the fourth quarter of 2024 to assess DM199’s safety and effectiveness in treating preeclampsia. The trial aims to enroll up to 120 participants at a cost-efficient price, with initial proof-of-concept results expected in the first half of 2025. This development could offer new hope for managing a condition that currently has no approved treatments in the U.S. or Europe.
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 March 5, 2026, involving DM199. The update was categorized as "No Objection Letter," with the company reporting: "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)."
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 3/5/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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