Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vorasidenib · 2 trials · 2 indications
The time from date of randomization to date of first documented radiographic progressive disease (PD), as assessed by the Blinded Independent Review Committee (BIRC), or date of death due to any cause, whichever occurs earlier.
Maximum observed plasma concentration of vorasidenib in substudy A
Time to maximum observed plasma concentration of vorasidenib in substudy A
Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of vorasidenib in substudy A
AUC from time 0 extrapolated to infinity (AUC0-inf) of vorasidenib in substudy A
Maximum observed plasma concentration of vorasidenib in substudy B
Time to maximum observed plasma concentration of vorasidenib in substudy B
Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of vorasidenib in substudy B
AUC from time 0 extrapolated to infinity (AUC0-inf) of vorasidenib in substudy B
| Arm | Type | Description |
|---|---|---|
| Randomized Double-Blind Phase: Vorasidenib | EXPERIMENTAL | - |
| Randomized Double-Blind Phase: Placebo | PLACEBO_COMPARATOR | - |
| Fasting condition / Low-fat meal | EXPERIMENTAL | A single oral dose of 1×40 mg vorasidenib tablet administered under fasted conditions or following a low-fat meal. |
| Low-fat meal / Fasted condition | EXPERIMENTAL | A single oral dose of 1×40 mg vorasidenib tablet administered following a low-fat meal or under fasted conditions. |
| Vorasidenib | EXPERIMENTAL | Single oral dose of vorasidenib 2×10 mg tablets administered on Day 1. |
| Vorasidenib and ciprofloxacin | EXPERIMENTAL | Single oral dose of vorasidenib 2×10 mg tablets administered on Day 1 and twice daily (morning and evening) oral doses of ciprofloxacin 1×500 mg tablet on Days 1 through 14. |
| Name | Type | Description |
|---|---|---|
| Vorasidenib | DRUG | For oral administration once daily |
| Placebo | DRUG | For oral administration once daily |
| Vorasidenib 40 mg Oral Tablet | DRUG | Single oral dose of 1×40 mg vorasidenib tablet administered : * under fasted conditions (all subjects will fast overnight for at least 10 hours prior to dosing and for at least 4 hours after dosing. * or following a low fat meal (approximatively 400 to 500 calories) (Substudy A) |
| Ciprofloxacin 500 mg Oral Tablet | DRUG | Twice daily (morning and evening) oral doses of ciprofloxacin 1×500 mg tablet on Days 1 through 14 (Substudy B) |
| Vorasidenib 10 mg Oral Tablet | DRUG | Single oral dose of vorasidenib 2×10 mg tablets administered on Day 1 (Substudy B) |
Inclusion Criteria: * Be at least 12 years of age (for Randomized Double-Blind phase) and weigh at least 40 kg. * Have a Karnofsky Performance Scale (KPS) score (for participants ≥16 years of age) or Lansky Play Performance Scale (LPPS) score (for participants \<16 years of age) of ≥80%. * Have Gra...
Vorasidenib is an investigational small molecule being studied for residual or recurrent Grade 2 glioma with an IDH1 or IDH2 mutation. It is also being evaluated in healthy subjects for pharmacokinetic studies. The drug is in clinical development and is not approved by the FDA.
Vorasidenib targets IDH1 and IDH2, which are enzymes frequently mutated in certain gliomas. As an inhibitor, it is designed to block the activity of these mutant enzymes. This mechanism is being studied in patients with IDH-mutant Grade 2 glioma.
Vorasidenib is being developed by Tango Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker TNGX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with IDH-mutant glioma.
Vorasidenib is in Phase 1 and Phase 3 clinical trials. A Phase 1 study in healthy subjects has been completed, and a Phase 3 study in Asian participants with residual or recurrent Grade 2 IDH-mutant glioma is active but not recruiting. The drug remains investigational.
Vorasidenib is being studied in two clinical trials. NCT05843708 is a completed Phase 1 study in healthy subjects evaluating the effect of food and ciprofloxacin on the drug's pharmacokinetics. NCT06780930 is an active Phase 3 study in Asian participants with residual or recurrent Grade 2 IDH-mutant glioma.
Yes, Vorasidenib is also known as AG-881 and S095032. The Phase 3 trial title refers to Vorasidenib (S095032/AG-881), confirming these names refer to the same drug. This compound is being developed by Tango Therapeutics for IDH-mutant glioma.