Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RG1662 · 6 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| RG1662 120 mg bid | EXPERIMENTAL | - |
| RG1662 240 mg bid | EXPERIMENTAL | - |
| Combination therapy RG1662 + itraconazole | EXPERIMENTAL | Days 20-29: Oral administration RG1662 twice daily within 30 minutes of a meal + 2 x 100 mg itraconazole once daily with food |
| RG1662 Monotherapy | EXPERIMENTAL | Days 1-10: RG1662 120 mg twice daily (b.i.d.) within 30 minutes of a meal for 10 days (Days 1 to 9, Day 10 only a.m. dose). (Cohort A subjects will receive 1 x 120 mg RG1662 tablets twice daily. In Cohorts B and C the dose of RG1662 will be decided upon following review of the interim safety and pharmacokinetic data of the 4 subjects in Cohort A.) |
| itraconazole Monotherapy | EXPERIMENTAL | Days 15-19: 200 mg of itraconazole twice daily for 5 days (Days 15 to 18, Day 19 only a.m. dose) |
| RG1662 plus metformin | EXPERIMENTAL | - |
| metformin alone | EXPERIMENTAL | - |
| RG1662 | EXPERIMENTAL | - |
| A | EXPERIMENTAL | - |
| B | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Orally twice daily, 26 weeks |
| RG1662 | DRUG | 120 mg (80 mg for subjects 12 and 13 years of age) orally twice daily, 26 weeks |
| itraconazole | DRUG | - |
| Omnipaque 300 | OTHER | 647 mg/mL of iohexol, equivalent to 300 mg/mL of iodine, used for assessment of glomerular function and other measure of renal function |
| metformin | DRUG | Single 850 mg dose of metformin |
Inclusion Criteria: * Individuals aged 12-30 years of age inclusive * Clinical diagnosis of Down syndrome (trisomy 21) confirmed by chromosomal analysis (karyotyping) * Males, or non-pregnant, non-lactating females. For females of childbearing potential, strict contraceptive prevention is required....
RG1662 is an investigational small molecule being studied for the treatment of cognitive impairment associated with Down Syndrome. It has been evaluated in clinical trials involving adults and adolescents with Down Syndrome, as well as in healthy volunteers for safety and pharmacokinetic studies.
RG1662 is being developed by Roche Holding AG, which trades under the ticker RHHBY on the OTC market. Roche has sponsored multiple clinical trials of RG1662 in Down Syndrome and healthy volunteer populations.
RG1662 has completed Phase 2 clinical development. The Phase 2 trial, known as CLEMATIS (NCT02024789), was completed with 173 participants. Earlier Phase 1 trials have also been completed. RG1662 is not approved and remains an investigational agent.
RG1662 has been studied in four completed trials: NCT01436955 and NCT01667367 (Phase 1 in Down Syndrome and healthy volunteers), NCT02024789 (Phase 2 CLEMATIS in Down Syndrome), and NCT02470832 (Phase 1 drug interaction study in healthy subjects).
RG1662 is also known as basmisanil. The Phase 2 CLEMATIS trial (NCT02024789) evaluated RG1662 in adults and adolescents with Down Syndrome, and the drug has been referenced under both names in clinical research.