Voranigo
Oncology· 1757 cited findings· 1 source document
Company: Servier
What the regulatory reviews say
Voranigo is a drug under regulatory review, with an application submitted on January 4, 2024, and an Accelerated Assessment agreement date of November 9, 2023. Scientific advice was provided on July 25, 2019, and February 23, 2023. The drug's efficacy has been evaluated in a Phase 3 clinical trial.
In preclinical studies, Vorasidenib, the active compound, demonstrated an IC50 for IDH1 mutant isoforms (R132H/C/G/L/S) ranging from 6-34 nM. It also showed significant reduction of 2-HG levels in xenograft models, with a 96.7% reduction in HT1080 chondrosarcoma/fibrosarcoma xenograft mice at a dose of 30 mg/kg, and a 98.5% reduction in U87 glioblastoma xenograft mice at a dose of 150 mg/kg. The drug's shelf-life is 30 months.
Safety assessments included evaluation of hERG current inhibition, with Vorasidenib showing > 30 µM IC50 for hERG current inhibition. The unbound human steady-state Cmax at 40 mg daily was 133 ng/ml. Vorasidenib also demonstrated 92% inhibition of the adenosine A3 receptor at 1 µM, with an IC50 of 1.50 µM.
Key figures — cited to the source page
| Vorasidenib IC50 for IDH1 mutant isoforms (R132H/C/G/L/S) | 6-34 | Servier — Voranigo EMA EPAR public assessment report (EMEA/H, p.21 |
| Vorasidenib reduction of 2-HG level in HT1080 xenograft mice model | 96.7 | Servier — Voranigo EMA EPAR public assessment report (EMEA/H, p.22 |
| Vorasidenib reduction of 2-HG level in U87 glioblastoma xenograft mice model | 98.5 | Servier — Voranigo EMA EPAR public assessment report (EMEA/H, p.22 |
| Vorasidenib IC50 for hERG current inhibition | > 30 | Servier — Voranigo EMA EPAR public assessment report (EMEA/H, p.23 |
| Vorasidenib unbound human steady-state Cmax at 40 mg daily | 133 | Servier — Voranigo EMA EPAR public assessment report (EMEA/H, p.23 |
| Application submission date | 4 January 2024 | Servier — Voranigo EMA EPAR public assessment report (EMEA/H, p.10 |
| Accelerated Assessment agreement date | 9 November 2023 | Servier — Voranigo EMA EPAR public assessment report (EMEA/H, p.10 |
| Shelf-life | 30 | Servier — Voranigo EMA EPAR public assessment report (EMEA/H, p.19 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.