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SAR446959

Phase 1

Osteoarthritis | Small molecule | Musculoskeletal |Sanofi|Last Updated: Jan 12, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

SAR446959 · 1 trial · 1 indication

Phase 1 1
NCT06704932A First-in-human Study to Investigate Safety and Tolerability of SAR446959 in Participants With Osteoarthritis of the KneeOsteoarthritis
COMPLETED32 Analytics
PHASE1COMPLETED
A First-in-human Study to Investigate Safety and Tolerability of SAR446959 in Participants With Osteoarthritis of the Knee
OsteoarthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with adverse events (AEs)/treatment emergent adverse events (TEAEs) including injection site reactions
Day 1 up to the end-of-study visit (Day 85)

Assessment of adverse events (AE) / treatment-emergent adverse events (TEAE).

Number of participants with potentially clinically significant abnormalities (PCSAs)
Day 1 up to the end-of-study visit (Day 85)

Count of PCSAs and descriptive statistics will be done on clinical laboratory, vital signs and 12-Lead ECG parameters.

Secondary Endpoints

Pharmacokinetic (PK) parameter of SAR446959: Cmax
Day 1 up to the follow up visit (Day 169)
PK parameter of SAR446959: AUClast
Day 1 up to the follow up visit (Day 169)
PK parameter of SAR446959: AUC
Day 1 up to the follow up visit (Day 169)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SAR446959EXPERIMENTALParticipants will receive a single intra-articular dose of SAR446959 on Day 1
PlaceboPLACEBO_COMPARATORParticipants will receive a single intra-articular dose of placebo on Day 1. The injection volume of the placebo will be the same as the injection volume for SAR446959 in the corresponding dose level cohort.

Interventions

NameTypeDescription
SAR446959DRUGPharmaceutical form:solution for injection-Route of administration:Intra-articular injection
PlaceboDRUGPharmaceutical form:solution for injection-Route of administration:Intra-articular injection
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Eligibility Criteria

Age Range45 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Participants must have a diagnosis of primary knee osteoarthritis, based on the American College of Rheumatology Clinical criteria using history and physical examination in the index knee * Participants must have index knee OA symptoms since at least 6 months before screening. *...

Countries:Germany
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Frequently asked questions about SAR446959

What is SAR446959 used for in osteoarthritis?

SAR446959 is an investigational small molecule being developed for the treatment of osteoarthritis. It is being studied in participants with osteoarthritis of the knee. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes SAR446959?

SAR446959 is being developed by Sanofi, a multinational pharmaceutical company traded on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical trials to evaluate the safety and tolerability of this investigational drug for osteoarthritis.

What phase is SAR446959 in?

SAR446959 is in Phase 1 clinical development. A first-in-human study has been completed to investigate its safety and tolerability in participants with osteoarthritis of the knee. The drug is investigational and has not been approved for any use.

What clinical trials is SAR446959 in?

SAR446959 has one completed clinical trial registered under NCT06704932. This was a Phase 1, first-in-human study that evaluated the safety and tolerability of the drug in 32 participants with osteoarthritis of the knee. The trial was conducted in Germany.

Is SAR446959 the same as any other drug?

No alternative names for SAR446959 have been disclosed. The drug is identified by its development code SAR446959 and is being studied under the clinical trial identifier NCT06704932. It is a distinct investigational compound being developed by Sanofi.