Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GZ402668 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| GZ402668 | EXPERIMENTAL | Dose 1 (up to a maximum optional Dose 2) will be given as a single subcutaneous administration under fed conditions. Acyclovir will be given twice daily starting on Day 1 and continuing for 28 days after investigational medicinal product administration. |
| Placebo | PLACEBO_COMPARATOR | A dose of matching placebo will be given as a single subcutaneous administration under fed conditions. Acyclovir will be given twice daily starting on Day 1 and continuing for 28 days after investigational medicinal product administration. |
| Dose 1 IV | EXPERIMENTAL | GZ402668 dose 1 intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy |
| Dose 2 IV | EXPERIMENTAL | GZ402668 dose 2 intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy |
| Dose 3 IV | EXPERIMENTAL | GZ402668 dose 3 intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy |
| Dose 3 SC | EXPERIMENTAL | GZ402668 dose 3 subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy |
| Dose 4 SC | EXPERIMENTAL | GZ402668 dose 4 subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy |
| Dose 5 SC | EXPERIMENTAL | GZ402668 dose 5 subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy |
| Placebo SC | PLACEBO_COMPARATOR | placebo subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy |
| Placebo IV | PLACEBO_COMPARATOR | placebo intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy |
| Name | Type | Description |
|---|---|---|
| GZ402668 | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
| Placebo | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
| Acyclovir | DRUG | Pharmaceutical form: tablet Route of administration: oral |
Inclusion criteria : * Male or female adult with a diagnosis of progressive multiple sclerosis (MS) including primary progressive MS, secondary progressive MS, or progressive relapsing MS. * Aged between 18 and 65 years, inclusive. * Body weight greater than 40.0 kg. * Female patients of child bear...
GZ402668 is an investigational small molecule being developed for the treatment of progressive multiple sclerosis, a form of multiple sclerosis characterized by gradual worsening of neurological function. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
GZ402668 is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical trials to evaluate the safety and tolerability of this investigational drug in patients with progressive multiple sclerosis.
GZ402668 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving patients with progressive multiple sclerosis. The drug is investigational and has not received regulatory approval for any use.
GZ402668 has been studied in two completed Phase 1 clinical trials: NCT02282826, a first-in-human single ascending dose study with 48 participants, and NCT02977533, a single ascending dose study with 20 participants. Both trials were conducted in Germany and enrolled patients with progressive multiple sclerosis.
No, GZ402668 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for progressive multiple sclerosis. The two completed trials were early-stage studies focused on safety and tolerability, and the drug has not yet progressed to later-stage trials or regulatory review.