Drugs / Idebenone
Idebenone
also known as
Catena · 6-(10-Hydroxydecyl)-2,3-dimethoxy-5-methyl-1,4-benxoquinone · CV-2619 · Hydroxydecyl ubiquinone · Idebenona · Idebenone,H10970363 · NSC-759228 · Oristar hdu · +2 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Raxone | — | 2015-09-08 | europa.eu ↗ |
| Refused (EMA) | EU (EMA) | Sovrima | — | 2009-04-27 | europa.eu ↗ |
Trials 26 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00950248 Comparator | Nov 2009 → Apr 2018 | primary progressive multiple sclerosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04152655 Comparator | Jan 2020 → Jan 2022 | Parkinson disease, REM sleep behavior disorder | Second Affiliated Hospital, School of Medicine, Zhejiang University | Withdrawn | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT05411978 Comparator | May 2022 → Jun 2024 | migraine disorder | Beijing Tiantan Hospital | Unknown | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04381091 Background | — | Leber hereditary optic neuropathy | Santhera Pharmaceuticals | No longer available | No outcome recorded |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 35 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Idebenone | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00747487 ↗29 |
| Known as | 6-(10-Hydroxydecyl)-2,3-dimethoxy-5-methyl-1,4-benxoquinone | “The chemical name for idebenone is 6-(10-Hydroxydecyl)-2,3-dimethoxy-5-methyl-1,4-benxoquinone.” NCT00229632 ↗ |
| Known as | Catena | “Twenty-one DMD patients (aged 8-16 years) were randomly assigned to daily treatment with 450 mg idebenone (Catena®) (n=13) or placebo (n=8) for 12 months.” PMID 21435876 ↗ Mar 20112“patients received idebenone (Catena(®), 150 mg film-coated tablets) at a weight-adjusted dose of 1,350/2,250 mg/day” PMID 21779958 ↗ Jul 2011 “patients receiving idebenone (Catena; 900 mg/d; N = 28) or placebo (N = 11) for 6 months.” PMID 23263355 ↗ Mar 2013 |
| Known as | CV-2619 | “This compound was synthesized and developed initially by Takeda Chemical Industries, Ltd. (Osaka, Japan) and designated as CV-2619.” NCT00229632 ↗ |
| Known as | Hydroxydecyl ubiquinone | ChEMBL registry synonym — accepted as the source's own label CHEMBL252556 ↗ |
| Known as | Idebenona | ChEMBL registry synonym — accepted as the source's own label CHEMBL252556 ↗ |
| Known as | Idebenone,H10970363 | “Idebenone,H10970363” NCT04071639 ↗ |
| Known as | NSC-759228 | ChEMBL registry synonym — accepted as the source's own label CHEMBL252556 ↗ |
| Known as | Oristar hdu | ChEMBL registry synonym — accepted as the source's own label CHEMBL252556 ↗ |
| Known as | Raxone | “Raxone (idebenone 300 mg t.i.d.) on days 3 and days 5 to 10” NCT02887443 ↗ |
| Known as | Sovrima | ChEMBL registry synonym — accepted as the source's own label CHEMBL252556 ↗ |
| Modality | Small molecule | — CHEMBL252556 ↗ |
| Route | Oral | “Oral idebenone was administered at 60 mg/kg divided in 3 doses per day for 1 month.” PMID 17562928 ↗ Jun 2007 |