Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BGG492 · 4 trials · 5 indications
Incidence of adrenal cortical adenomas as assessed by non-contrast MRI of the abdomen (CT or ultrasound of the abdomen was permitted if MRI was contraindication)
Incidence of uterine endometrial stromal sarcomas as assessed by sonogram/biopsy (females)
By measuring the number and percent of patients having any AE (advent event) by primary system organ class and/or preferred term. By laboratory, vital sign, and ECG data, summary statistics of values and change from baseline
| Arm | Type | Description |
|---|---|---|
| BGG492 | EXPERIMENTAL | This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to \> 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day |
| Active | EXPERIMENTAL | - |
| Comparator | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Cohort 1 | EXPERIMENTAL | - |
| Cohort II | EXPERIMENTAL | - |
| Cohort III | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| MRI, CT or ultrasound was permitted if MRI was contraindicated | PROCEDURE | MRI/CT/ultrasound of abdomen |
| Dexamethasone Supression Test | PROCEDURE | Low dose of dexamethasone is administered in the evening; the next morning, a blood sample is collected to measure cortisol |
| Sonogram | PROCEDURE | Sonogram of the uterus (females only) |
| Biopsy | PROCEDURE | Uterine endometrial biopsy (females only) |
| BGG492 | DRUG | No study-drug was administered in this study |
| Sumatriptan | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: 1. Written informed consent had to be obtained before any assessment was performed; 2. Patients had to be cooperative, willing to participate in the study assessments, and be able to report AEs (adverse events) themselves or have a caregiver who can record and report the events;...
BGG492 is an investigational small molecule being studied for several conditions, including adrenocortical adenoma, migraine, photosensitive epilepsy, and partial onset seizures. It is developed by Novartis AG and has been evaluated in Phase 2 clinical trials, though it is not approved and remains in clinical development.
The specific molecular target of BGG492 is not disclosed in available information. As a small molecule, it is being investigated for potential effects in neurological and oncological conditions, but its mechanism of action has not been publicly detailed.
BGG492 is developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker NVS. Novartis has sponsored clinical trials to evaluate the drug's safety and efficacy in various indications.
BGG492 is in Phase 2 clinical development. It has completed multiple Phase 2 trials, but it is not approved by regulatory authorities. The drug remains investigational, and further studies would be needed to establish its safety and efficacy for any indication.
BGG492 has completed several Phase 2 trials, including NCT00784212 for photosensitive epilepsy, NCT00892203 for migraine, NCT01338805 for partial onset seizures, and NCT02150213 as a safety follow-up for adrenocortical adenoma and other conditions. All trials are completed, with no active trials ongoing.
BGG492 is not known to have alternative names. It is a unique investigational compound developed by Novartis AG, and no other names have been associated with it in clinical trial records or public information.