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 · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed DMD-related muscular dystrophy 1 milestone | |||||
| Filed | EU (EMA) | Puldysa | DMD-related muscular dystrophy | — | “A marketing authorization application for Puldysa® (idebenone) is currently under review by the European Medicines Agency.” santhera.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Raxone | — | 2015-09-08 | europa.eu ↗ |
| Refused (EMA) | EU (EMA) | Sovrima | — | 2009-04-27 | europa.eu ↗ |
Trials 26
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2023-02-08 | Santhera Pharmaceuticals | Regulatory Santhera Concludes Agreement with French Authorities on Raxone® Reimbursement and Plans to Submit a Request for an Early Access Program for Vamorolone santhera.com ↗
Santhera Pharmaceuticals (SIX: SANN) announces that it has secured a final reimbursement agreement with the French authorities related to Raxone® (idebenone) for the treatment of Leber's hereditary optic neuropathy (LHON) and sales are expected to resume shortly. |
| 2021-06-23 | Santhera Pharmaceuticals | Results Santhera Announces Phase 4 LEROS Trial with Raxone® Met Primary Endpoint in Patients with Leber’s Hereditary Optic Neuropathy santhera.com ↗
Santhera Pharmaceuticals (SIX: SANN) announces positive topline results from its long-term Phase 4 LEROS study with Raxone® (idebenone) in the treatment of Leber’s hereditary optic neuropathy (LHON). |
| 2020-10-06 | Santhera Pharmaceuticals | Results Santhera to Discontinue Phase 3 SIDEROS Study and Development of Puldysa® in Duchenne Muscular Dystrophy (DMD) and Focus on Vamorolone santhera.com ↗
Data from an interim analysis conducted by the independent Data and Safety Monitoring Board (DSMB) concluded that the study was unlikely to meet its primary endpoint. |
| 2020-06-23 | Santhera Pharmaceuticals | Regulatory UK’s MHRA renews EAMS Scientific Opinion for Santhera’s Idebenone in Duchenne Muscular Dystrophy santhera.com ↗
With this renewal, the MHRA again confirmed its positive scientific opinion for idebenone under the EAMS while a corresponding European marketing authorization application (MAA) is currently under review. |
| 2020-05-29 | Santhera Pharmaceuticals | Regulatory Santhera Provides Update on the Ongoing Regulatory Review of Puldysa® (Idebenone) by the CHMP in Duchenne Muscular Dystrophy (DMD) santhera.com ↗
Santhera Pharmaceuticals (SIX: SANN) announces that the EMA’s CHMP has granted a requested extension of the clock-stop in the regulatory procedure for its conditional marketing authorization (CMA) application for Puldysa® ( idebenone) in Duchenne muscular dystrophy (DMD). |
| 2019-11-19 | Santhera Pharmaceuticals | Results Santhera Announces Publication of Long-term Idebenone Data from SYROS Study in Duchenne Muscular Dystrophy santhera.com ↗ |
| 2019-09-17 | Santhera Pharmaceuticals | Results Santhera to Present Long-Term Data with Puldysa® (Idebenone) in Duchenne Muscular Dystrophy at Upcoming Medical Congresses santhera.com ↗
Long-term treatment with idebenone can result in a consistent and sustained reduction in the rate of respiratory function decline. |
| 2019-06-25 | Santhera Pharmaceuticals | Regulatory EMA Validates Santhera’s Marketing Authorization Application for Puldysa® in Duchenne Muscular Dystrophy santhera.com ↗
Santhera Pharmaceuticals (SIX: SANN) announces that the European Medicines Age ncy (EMA) has validated its marketing authorization application (MAA) for Puldysa® (idebenone) in the treatment of respiratory dysfunction in patients with Duchenne muscular dystrophy (DMD) who are not using glucocorticoids. |
| 2019-06-24 | Santhera Pharmaceuticals | Regulatory UK’s MHRA renews EAMS Scientific Opinion for Santhera’s Idebenone in Duchenne Muscular Dystrophy santhera.com ↗
With this renewal, the MHRA again confirmed its positive scientific opinion for idebenone under the EAMS while a corresponding European marketing authori zation application (MAA) has recently been submitted. |
| 2019-05-27 | Santhera Pharmaceuticals | Regulatory Santhera Submits Marketing Authorization Application to the European Medicines Agency for Puldysa® (Idebenone) in Duchenne Muscular Dystrophy santhera.com ↗
Santhera Pharmaceuticals (SIX: SANN) announces that it has submitted a marketing authorization application (MAA) for Puldysa® (idebenone) for the treatment of respiratory dysfunction in patients with Duchenne muscular dystrophy (DMD ) to the European Medicines Agency (EMA). |
| 2019-04-15 | Santhera Pharmaceuticals | Results Santhera to Present Long-term Efficacy Results with Idebenone in DMD at the 2019 MDA Clinical and Scientific Conference santhera.com ↗
Posters presented at the MDA conference show consistent long-term efficacy data from two randomized placebo-controlled studies and their extended long-term data collections in patients treated with idebenone (Posters #7 and #9). |
| 2019-03-28 | Santhera Pharmaceuticals | Results Santhera Provides Update on Filing for Conditional Marketing Authorization in Europe for Puldysa® (Idebenone) in Duchenne Muscular Dystrophy santhera.com ↗
In its entirety, these new data demonstrate clinically relevant patient benefits and sustained therapeutic efficacy during treatment with idebenone for up to six years in patients with DMD . |
| 2019-02-25 | Santhera Pharmaceuticals | Results Santhera’s SYROS Study Shows Long-term Efficacy with Idebenone in Slowing Respiratory Function Loss in Patients with Duchenne Muscular Dystrophy santhera.com ↗
Switching to and maintaining long -term treatment with idebenone reduced the annual rate of decline in forced vital capacity percent of predicted (FVC%p) by 50%. |
All press releases naming this drug 18 releases
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 NCT04534023 ↗ |
| 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 |