Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as RIPK1 inhibitor
SAR443820 · 4 trials · 4 indications
Maximum plasma concentration
Area under the plasma concentration versus time curve from time zero to the real time last
Area under the plasma concentration versus time curve
| Arm | Type | Description |
|---|---|---|
| Part-A, Period-1 | EXPERIMENTAL | Single dose of SAR443820 tablet on Day 1 |
| Part-A, Period-2 | EXPERIMENTAL | Single dose of SAR443820 tablet on Day 6, and erythromycin ethyl succinate (EES) three-time a day (TID) from Day 1 to Day 9 |
| Part-B, Period-1 | EXPERIMENTAL | Single dose of SAR443820 capsule on Day 1 |
| Part-B, Period-2 | EXPERIMENTAL | Single dose of SAR443820 capsule on Day 6, and Itraconazole once daily (QD) from Day 1 to Day 11 |
| SAR443820 | EXPERIMENTAL | Participants will receive a single sequence of 3 different doses of SAR443820 in a total of 3 treatment periods |
| Treatment A | EXPERIMENTAL | Single dose of SAR443820 tablet in fasted condition |
| Treatment B | EXPERIMENTAL | Single dose of SAR443820 capsule in fasted condition |
| Treatment C | EXPERIMENTAL | Single dose of SAR443820 tablet in fasted condition |
| Treatment D | EXPERIMENTAL | Single dose of SAR443820 tablet in fed condition |
| Placebo | PLACEBO_COMPARATOR | Single dose oral ascending dose (part 1a) and multiple ascending oral dose (part 2) of matching placebo |
| Name | Type | Description |
|---|---|---|
| SAR443820 | DRUG | Tablet by oral administration |
| Erythromycin ethyl succinate | DRUG | Tablet by oral administration |
| Itraconazole | DRUG | Capsule by oral administration |
| RIPK1 inhibitor | DRUG | Capsule Oral |
| Placebo | DRUG | Matching Capsule / Oral |
Inclusion Criteria: * Part A: male or female participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent * Part B: male participant only must be 18 to 55 years of age inclusive, at the time of signing the informed consent * Body weight between 50.0 and 100.0 kg,...
SAR443820 is an investigational small molecule being developed by Sanofi for amyotrophic lateral sclerosis, a progressive neurological disease. It is in Phase 1 clinical development and has been studied in healthy adult volunteers. It has not been approved by the FDA and remains an experimental therapy in early-stage testing.
SAR443820 is being developed as a potential treatment for amyotrophic lateral sclerosis, a neurodegenerative condition affecting motor neurons. All three completed clinical trials listed SAR443820 under ALS-related conditions, with most enrolling healthy volunteers rather than patients. It is investigational and has not been approved for any use.
SAR443820 is developed by Sanofi, the French pharmaceutical company whose shares trade on the New York Stock Exchange under the ticker SNY. Sanofi is the sponsor of the clinical program evaluating the compound in amyotrophic lateral sclerosis and in healthy volunteer studies.
SAR443820 is in Phase 1 clinical development. All three of its registered trials are Phase 1 studies, and all three have been completed. The program has not advanced to later-stage trials, and the drug is not FDA approved.
SAR443820 has been evaluated in three completed Phase 1 trials: NCT05795907, a single and multiple ascending dose study in 84 healthy adults; NCT05797701, a bioavailability study comparing tablet and capsule forms in 18 participants; and NCT05797753, a drug interaction study with erythromycin and itraconazole in 16 participants.
The three completed Phase 1 trials of SAR443820 enrolled a total of 118 participants. NCT05795907 enrolled 84 healthy adults, NCT05797701 enrolled 18, and NCT05797753 enrolled 16. The studies were conducted in the United States and included randomized, double-blind, controlled designs.