Drugs / Dexpramipexole
Dexpramipexole
Trials 19
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT01607034 | Jun → Jul 2012 | — | Knopp Biosciences | Completed | No outcome recorded |
| Phase 1 | NCT01597310 | May → Jul 2012 | — | Knopp Biosciences | Completed | No outcome recorded |
| Phase 1 | NCT01536249 | Mar → Apr 2012 | amyotrophic lateral sclerosis | Knopp Biosciences | Completed | No outcome recorded |
| Phase 1 | NCT01511029 | Jan → May 2012 | amyotrophic lateral sclerosis | Knopp Biosciences | Completed | No outcome recorded |
| Phase 1 | NCT01449578 | Nov 2011 → Jan 2012 | amyotrophic lateral sclerosis | Knopp Biosciences | Completed | No outcome recorded |
| Phase 1 | NCT01424163 | Aug 2011 → Feb 2012 | amyotrophic lateral sclerosis | Knopp Biosciences | Completed | No outcome recorded |
| Phase 1 | NCT01424176 | Jul 2011 → Jan 2012 | amyotrophic lateral sclerosis, impaired renal function disease | Knopp Biosciences | Completed | No outcome recorded |
| Phase 26 trials · 1 met primary | ||||||
| Phase 2 | NCT06533553 | Jul 2024 → Oct 2025 overdue | chronic obstructive pulmonary disease | Areteia Therapeutics | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02217332 | Aug 2014 → Dec 2016 | chronic rhinosinusitis | Knopp Biosciences | Completed | No outcome recorded |
| Phase 2 | NCT02101138 | Mar 2014 → Dec 2016 | hypereosinophilic syndrome | National Institute of Allergy and Infectious Diseases (NIAID) | Unknown | No outcome recorded |
| Phase 2 | NCT01388478 | Jul 2011 → Jan 2014 | Alzheimer disease | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 2 | NCT00931944 | Jul 2009 → Jul 2013 | amyotrophic lateral sclerosis | Knopp Biosciences | Completed | No outcome recorded |
| Phase 2 | NCT00647296 | Apr 2008 → Jul 2009 | amyotrophic lateral sclerosis | Knopp Biosciences | Completed | Met primary |
| Phase 36 trials · 1 missed | ||||||
| Phase 3 | NCT06388889 | Jun 2024 → Dec 2025 | T2-high asthma | Areteia Therapeutics | Terminated | No outcome recorded |
| Phase 3 | NCT05813288 | Mar 2023 → Dec 2025 | asthma | Areteia Therapeutics | Terminated | No outcome recorded |
| Phase 3 | NCT05763121 | Jan 2023 → Dec 2025 | asthma | Areteia Therapeutics | Terminated | No outcome recorded |
| Phase 3 | NCT05748600 | Jan 2023 → Sep 2025 overdue | acute asthma | Areteia Therapeutics | Active not recruiting | No outcome recorded |
| Phase 3 | NCT01622088 | Jun 2012 → Feb 2013 | amyotrophic lateral sclerosis | Knopp Biosciences | Terminated | No outcome recorded |
| Phase 3 | NCT01281189 | Mar 2011 → Nov 2012 | amyotrophic lateral sclerosis | Knopp Biosciences | Completed | Missed primary |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT04046939 Comparator | Aug 2019 → Dec 2020 | asthma | Knopp Biosciences | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2021-01-14 | Knopp Biosciences | Results Knopp Biosciences Announces Positive Top-Line Results from the Phase 2 EXHALE Trial of Oral Dexpramipexole in Moderate-to-Severe Eosinophilic Asthma knoppbio.com ↗
The EXHALE study met its primary endpoint, with dexpramipexole demonstrating a statistically significant, dose-dependent reduction in blood absolute eosinophil count (AEC) from Baseline to Week 12 compared to placebo when added to standard of care. |
| 2013-01-03 | Biogen | Results Biogen Idec Reports Top-Line Results from Phase 3 Trial Investigating Dexpramipexole in People with Amyotrophic Lateral Sclerosis (ALS) biogen.com ↗
The trial did not meet its primary endpoint, a joint rank analysis of function and survival, and no efficacy was seen in the individual components of function or survival. |
All press releases naming this drug 7 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Dexpramipexole | “A Single and Multiple Dose, Open-Label Study of the Pharmacokinetics, Safety, and Tolerability of Dexpramipexole (BIIB050) in Healthy Japanese and Caucasian Subjects” NCT01424163 ↗ |
| Known as | (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine | “We tested the putative mitochondrial modulator dexpramipexole (KNS-760704; (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine) in subjects with ALS in a two-part,...” PMID 22101764 ↗ Nov 2011 |
| Known as | BIIB050 | “A Single-Center, Randomized, Blinded, Placebo- and Active-Controlled Crossover Study to Evaluate the Effect of Dexpramipexole (BIIB050) on the QTc Interval in Healthy Volunteers” NCT01511029 ↗2“A Single and Multiple Dose, Open-Label Study of the Pharmacokinetics, Safety, and Tolerability of Dexpramipexole (BIIB050) in Healthy Japanese and Caucasian Subjects” NCT01424163 ↗ “An Open-Label Study to Assess the Effect of Cimetidine on the Pharmacokinetics of Dexpramipexole (BIIB050) in Healthy Volunteers” NCT01536249 ↗ |
| Known as | Dexpramipexol | ChEMBL registry synonym — accepted as the source's own label CHEMBL249420 ↗ |
| Known as | Dexpramipexole Dihydrochloride | “Drug: Dexpramipexole Dihydrochloride” NCT05813288 ↗2“Drug: Dexpramipexole Dihydrochloride” NCT05748600 ↗ “Drug: Dexpramipexole Dihydrochloride” NCT06388889 ↗ |
| Known as | Dexpramipexole dihydrochloride monohydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL249420 ↗ |
| Known as | KNS 760704 | “Study to Evaluate Safety and Efficacy of Dexpramipexole (KNS-760704) in Subjects With Hypereosinophilic Syndrome” NCT02101138 ↗ |
| Known as | KNS-760704 ANHYDROUS | ChEMBL registry synonym — accepted as the source's own label CHEMBL249420 ↗ |
| Known as | Pramipexole related compound d | ChEMBL registry synonym — accepted as the source's own label CHEMBL249420 ↗ |
| Known as | R-pramipexole | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01388478 ↗ |
| Known as | SND 919CL2X | ChEMBL registry synonym — accepted as the source's own label CHEMBL249420 ↗ |
| Known as | SND-919CL2X MONOHYDRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL249420 ↗ |
| Modality | Small molecule | “Dexpramipexole (BIIB050, KNS-760704; (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazolediamine dihydrochloride monohydrate) is a synthetic amino-benzothiazole.” NCT01424176 ↗ |
| Route | Oral | “taken orally twice daily” NCT00647296 ↗ |