Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SAR444671
Rilzabrutinib crystalline form · 1 trial · 2 indications
Cmax: maximum plasma concentration
AUClast: area under the plasma concentration versus time curve from time zero to the last measurable concentration
AUC: area under the plasma concentration versus time curve extrapolated to infinity
| Arm | Type | Description |
|---|---|---|
| Treatment A: SAR444671 amorphous fasted | ACTIVE_COMPARATOR | Participants will receive single oral dose of amorphous tablet formulation rilzabrutinib (SAR444671) under fasted conditions on Day 1 for one period |
| Treatment B: SAR444671 crystalline fasted | EXPERIMENTAL | Participants will receive single oral dose of crystalline tablet formulation rilzabrutinib (SAR444671) under fasted conditions on Day 1 for one period |
| Treatment C: SAR444671 amorphous fed | ACTIVE_COMPARATOR | Participants will receive single oral dose of amorphous tablet formulation rilzabrutinib (SAR444671) under fed conditions on Day 1 for one period |
| Treatment D: SAR444671 crystalline fed | EXPERIMENTAL | Participants will receive single oral dose of crystalline tablet formulation rilzabrutinib (SAR444671) under fed conditions on Day 1 for one period |
| Name | Type | Description |
|---|---|---|
| Rilzabrutinib crystalline form | DRUG | Pharmaceutical form:Film coated tablet Route of administration:Oral |
| Rilzabrutinib amorphous form | DRUG | Pharmaceutical form:Film coated tablet Route of administration:Oral |
Inclusion Criteria: * Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive * Laboratory parameters within the normal range, unless the Investigator considers an abnormality to be c...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE3 | Anifrolumab |
| argenx SE Sponsored ADR | ARGX | 2 | PHASE3 | Efgartigimod PH20 SC, Empasiprubart |
| Pfizer Inc. | PFE | 1 | PHASE3 | Dazukibart |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY002-072 |
| Cabaletta Bio, Inc. | CABA | 1 | PHASE2 | CABA-201 |
| Kyverna Therapeutics, Inc. | KYTX | 1 | - | KYV-101 |
Rilzabrutinib crystalline form is a small molecule being developed by Sanofi for autoimmune disorders. It is a crystalline version of rilzabrutinib, an oral BTK inhibitor. It is in Phase 1 clinical development and has received an orphan drug designation from the FDA.
Rilzabrutinib crystalline form targets Bruton's tyrosine kinase (BTK). It acts as a BTK inhibitor, which is a class of drugs that block a signaling enzyme involved in immune cell activation. This mechanism is being explored for autoimmune conditions.
Rilzabrutinib crystalline form is developed by Sanofi, a global pharmaceutical company. Sanofi trades on the Nasdaq under the ticker symbol SNY.
Rilzabrutinib crystalline form is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The Phase 1 program includes a completed trial in healthy volunteers.
Rilzabrutinib crystalline form has been studied in one completed Phase 1 trial, NCT06342700. This trial was a food effect and relative bioavailability study in 28 healthy participants, conducted in the United States. It was randomized and active-controlled.
Rilzabrutinib crystalline form is a specific crystalline form of rilzabrutinib. Rilzabrutinib is the active pharmaceutical ingredient, and the crystalline form refers to its solid-state structure. Both are associated with Sanofi's development program.