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Recombinant human tissue kallikrein
Recombinant human tissue kallikrein is a Small molecule drug developed by DiaMedica Therapeutics Inc. It is currently in Phase 2 development. Also known as: DM199.
Recombinant human tissue kallikrein is being studied as a potential treatment for conditions such as acute ischemic stroke and ACE inhibitor-induced angioedema. The exact mechanism of action of recombinant human tissue kallikrein is currently unknown.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Recombinant human tissue kallikrein |
|---|---|
| Also known as | DM199 |
| Sponsor | DiaMedica Therapeutics Inc |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Treatment of Acute Ischemic Stroke (ReMEDy2 Trial) (PHASE2, PHASE3)
- Safety and Efficacy of Conestat Alfa for ACE-Induced Angioedema (PHASE3)
- Evaluation to Assess Safety and Tolerability of DM199 in Subjects With Acute Ischemic Stroke (PHASE2)
- An Open Label, Phase 1b, Ascending Dose Study of DM199 (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Recombinant human tissue kallikrein CI brief — competitive landscape report
- Recombinant human tissue kallikrein updates RSS · CI watch RSS
- DiaMedica Therapeutics Inc portfolio CI
Frequently asked questions about Recombinant human tissue kallikrein
What is Recombinant human tissue kallikrein?
Who makes Recombinant human tissue kallikrein?
Is Recombinant human tissue kallikrein also known as anything else?
What development phase is Recombinant human tissue kallikrein in?
Related
- Manufacturer: DiaMedica Therapeutics Inc — full pipeline
- Also known as: DM199
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing