Drugs / Sevuparin
Sevuparin
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03853421 | Feb → May 2019 | — | Modus Therapeutics AB | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01442168 | Sep 2011 → Sep 2013 | Plasmodium falciparum malaria | Modus Therapeutics AB | Terminated | No outcome recorded |
| Phase 21 trial · 1 missed | ||||||
| Phase 2 | NCT02515838 | Jul 2015 → May 2019 | sickle cell disease | Modus Therapeutics AB | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2019-05-13 | Modus Therapeutics AB | Results Modus Therapeutics Announces The Results Of Its Global, Randomized, Placebo-Controlled Phase 2 Clinical Trial Evaluating Sevuparin For The Management Of Acute Vaso-Occlusive Crisis (VOC) In Patients With Sickle Cell Disease (SCD) modustx.com ↗
Data from the study failed to show a meaningful benefit in the total study population, however, the data suggests that sevuparin, at the administered doses, is safe and well tolerated in this patient population. |
| 2018-11-30 | Modus Therapeutics AB | Regulatory Modus Therapeutics Announces FDA Acceptance Of Sevuparin IND For Treatment Of Sickle Cell Disease modustx.com ↗
Modus Therapeutics AB, a company developing innovative treatments in disease areas with high unmet medical need with a focus on sickle cell disease (SCD), announces that the FDA has accepted its sevuparin IND for the treatment of SCD. |
| 2018-04-18 | Modus Therapeutics AB | Regulatory Sevuparin Receives Rare Pediatric Disease Designation From FDA For The Treatment Of Children With Sickle Cell Disease modustx.com ↗
We are very pleased with the FDA’s decision to grant a rare pediatric disease designation to sevuparin for SCD. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-03-10 | Modus Therapeutics AB | Modus Therapeutics Announces New Strategy for the Clinical Development of Sevuparin as a Potential Treatment for Sepsis/Septic shock modustx.com ↗ |
| 2019-05-13 | Modus Therapeutics AB | Modus Therapeutics Announces The Results Of Its Global, Randomized, Placebo-Controlled Phase 2 Clinical Trial Evaluating Sevuparin For The Management Of Acute Vaso-Occlusive Crisis (VOC) In Patients With Sickle Cell Disease (SCD) modustx.com ↗ |
| 2019-02-22 | Modus Therapeutics AB | First Cohort Dosed In U.S. Phase 1 Study Of Subcutaneously Administered Sevuparin modustx.com ↗ |
| 2018-11-30 | Modus Therapeutics AB | Modus Therapeutics Announces FDA Acceptance Of Sevuparin IND For Treatment Of Sickle Cell Disease modustx.com ↗ |
| 2018-04-18 | Modus Therapeutics AB | Sevuparin Receives Rare Pediatric Disease Designation From FDA For The Treatment Of Children With Sickle Cell Disease modustx.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sevuparin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03853421 ↗ |
| Known as | DF-02 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297825 ↗ |
| Known as | Sevuparin/DF02 | “Sevuparin/DF02 as an Adjunctive Therapy in Subjects Affected With Uncomplicated Falciparum Malaria” NCT01442168 ↗ |
| Modality | Other / unclassified | “novel non-anticoagulant low molecular weight heparinoid” PMID 33894169 ↗ May 2021 |
| Route | Intravenous | “sevuparin was administered via short intravenous infusions” PMID 29244851 ↗ Dec 2017 |