Drugs / Nafamostat
Nafamostat
also known as
Nafamostat Mesilate · nafamostat mesylate · FUT · FUT-175 · Nafamostat dimethanesulfonate · Ronastat
Small molecule targets TMPRSS2 via inhibition
Trials 19
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT06500793 | Nov 2024 → Dec 2026 expected | — | Ensysce Biosciences | Recruiting | No outcome recorded |
| Phase 1 | NCT05090280 | Dec 2021 → Apr 2023 | — | Ensysce Biosciences | Completed | No outcome recorded |
| Phase 1 | NCT04406415 | Sep → Nov 2020 | — | Ensysce Biosciences | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04473053 | Jul 2020 → Apr 2025 | COVID-19 | University of Edinburgh | Completed | No outcome recorded |
| Phase 24 trials · 1 missed | ||||||
| Phase 2 | NCT07469072 | Apr 2026 → Mar 2027 expected | — | Zhujiang Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05555641 | Dec 2022 → Oct 2024 | — | Xiaobo Yang, MD | Unknown | No outcome recorded |
| Phase 2 | NCT04628143 | Dec 2020 → Apr 2021 | COVID-19 | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 2 | NCT04623021 | Sep → Dec 2020 | COVID-19 | Chong Kun Dang Pharmaceutical | Completed | Missed primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04418128 | Jun 2020 → Mar 2021 | COVID-19 | Gyeongsang National University Hospital | Unknown | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT04390594 | Aug 2020 → Feb 2023 | COVID-19 | Institut Pasteur de Dakar | Terminated | No outcome recorded |
| Phase 3 | NCT04483960 | Jul 2020 → Jul 2025 | COVID-19 | University of Melbourne | Unknown | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT07518303 | Jun 2026 → Jun 2028 expected | acute kidney injury, infectious disease with sepsis | Jianfeng Xie | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06375616 | Apr 2024 → Apr 2027 expected | infectious disease with sepsis | Shen Lei | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06078839 | Oct 2023 → Oct 2026 expected | infectious disease with sepsis | Xu Li | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT01001403 | Mar 2009 → Mar 2010 | — | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01761994 | Sep 2007 → Aug 2010 | acute kidney injury | Yonsei University | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT06994312 | Jul 2025 → May 2028 expected | blood coagulation disease | The First Hospital of Jilin University | Not yet recruiting | No outcome recorded |
| — | NCT06676085 | May 2025 → Dec 2027 expected | — | Beijing Chao Yang Hospital | Recruiting | No outcome recorded |
| — | NCT06276010 | Jul 2024 → Nov 2026 expected | — | Xiaotong Hou | Recruiting | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 2/3 | NCT04352400 Comparator | Jun 2021 → Dec 2024 | COVID-19 | University Hospital Padova | Unknown | No outcome recorded |
| Phase 3 | NCT01486485 Comparator | Mar 2012 → Aug 2013 | acute kidney injury | Seoul National University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02478242 Comparator | Jul 2010 → Jun 2015 | acute kidney injury | Kyungpook National University Hospital | Completed | No outcome recorded |
| — | NCT05874674 Comparator | Dec 2023 → Dec 2025 overdue | hemorrhagic disease | Wonju Severance Christian Hospital | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2025-01-22 | Ensysce Biosciences | Results Ensysce Biosciences Announces Positive Interim Data for Breakthrough Therapy PF614-MPAR ensysce.com ↗
The PF614-MPAR-102 study showed that a 100 mg dosage form of PF614-MPAR provides overdose protection when a greater-than-prescribed dose is consumed at one time. |
| 2022-12-19 | Ensysce Biosciences | Results Ensysce Biosciences Announces Data from PF614-MPAR-101-Part A Successfully Demonstrating Opioid Overdose Protection ensysce.com ↗
Additionally, and as anticipated, the results of the study demonstrated that a large overdose of PF614-MPAR would result in diminished oxycodone release and uptake as compared to an equivalent amount of an unprotected opioid. |
| 2022-05-05 | Ensysce Biosciences | Results Ensysce Biosciences Announces New Clinical Results from Trials PF614-102 and PF614-MPAR-101 ensysce.com ↗
This data demonstrated how the combination product PF614-MPAR could reduce the trypsin activation and reduce the release of oxycodone in a simulated overdose situation. |
| 2022-03-29 | Talphera, Inc | Results AcelRx Pharmaceuticals Announces Publication of Clinical Data Finding Potential Benefits of Nafamostat Compared to Regional Citrate for Anticoagulation of the Dialysis Circuit talphera.com ↗
Study results demonstrate that nafamostat had similar efficacy as citrate, while providing lower toxicity and lower costs to the hospital over standard citrate anticoagulation. |
| 2020-04-15 | Ensysce Biosciences | Regulatory Ensysce, a California Based Biotech Company With a Mission to Solve the Opioid Crisis, Exploring a Treatment for COVID-19. ensysce.com ↗
Ensysce has a safety package prepared and has requested Emergency Use Authorization from the FDA to move into a trial with oral nafamostat in the United States. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-01-22 | Ensysce Biosciences | Ensysce Biosciences Announces Positive Interim Data for Breakthrough Therapy PF614-MPAR ensysce.com ↗ |
| 2022-12-19 | Ensysce Biosciences | Ensysce Biosciences Announces Data from PF614-MPAR-101-Part A Successfully Demonstrating Opioid Overdose Protection ensysce.com ↗ |
| 2022-05-05 | Ensysce Biosciences | Ensysce Biosciences Announces New Clinical Results from Trials PF614-102 and PF614-MPAR-101 ensysce.com ↗ |
| 2022-03-29 | Talphera, Inc | AcelRx Pharmaceuticals Announces Publication of Clinical Data Finding Potential Benefits of Nafamostat Compared to Regional Citrate for Anticoagulation of the Dialysis Circuit talphera.com ↗ |
| 2020-04-15 | Ensysce Biosciences | Ensysce, a California Based Biotech Company With a Mission to Solve the Opioid Crisis, Exploring a Treatment for COVID-19. ensysce.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 27 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Nafamostat | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05555641 ↗ |
| Known as | FUT | “We evaluated clinical outcomes of disseminated intravascular coagulation (DIC) in patients with hematological malignancies treated with synthetic protease inhibitors (SPIs) and...” PMID 30536180 ↗ Dec 2018 |
| Known as | FUT-175 | ChEMBL registry synonym — accepted as the source's own label CHEMBL273264 ↗ |
| Known as | Nafamostat dimethanesulfonate | ChEMBL registry synonym — accepted as the source's own label CHEMBL273264 ↗ |
| Known as | Nafamostat Mesilate | “Nafamostat mesilate, a serine proteinase inhibitor, while inhibiting various clotting factors in filter circuit, is characterized by short half life resulting in little...” NCT01486485 ↗9“Investigational drug: Nafamostat Mesilate for Injection” NCT07469072 ↗ “Drug: Nafamostat Mesilate” NCT04352400 ↗ “Drug: Nafamostat Mesilate” NCT04473053 ↗ “Drug: Nafamostat Mesilate” NCT04406415 ↗ |
| Known as | nafamostat mesylate | “test the clinical efficacy of nafamostat mesylate (administered intravenously) on top of best standard of care.” NCT04352400 ↗8“BACKGROUND: Nafamostat mesylate is a potent in vitro antiviral agent” PMID 38320527 ↗ Oct 2023 “One such drug is nafamostat mesylate.” PMID 35152152 ↗ Feb 2022 |
| Known as | Ronastat | ChEMBL registry synonym — accepted as the source's own label CHEMBL273264 ↗ |
| Action | Inhibit | “inhibit SARS CoV2 infection via inhibition of viral entry due to inhibition of TMPRSS2” NCT04473053 ↗ |
| Modality | Small molecule | “treated with synthetic protease inhibitors (SPIs) and compared the effects of gabexate mesilate (FOY) and nafamostat mesilate (FUT)” PMID 30536180 ↗ Dec 2018 |
| Route | Intravenous | “received 0.2 mg/kg of nafamostat mesilate intravenously 1 min before reperfusion of the liver graft.” NCT01001403 ↗ |
| Target | TMPRSS2 | “inhibition of TMPRSS2” NCT04473053 ↗ |