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SAR448501

Phase 1

B-cell Non Hodgkin Lymphoma | Small molecule | Oncology |Sanofi|Last Updated: May 22, 2026

Target and mechanism

Molecular targetmyeloid cells
Target classCell Type
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment96

FDA Designations

No designations recorded

Clinical trial landscape

SAR448501 · 2 trials · 3 indications

Phase 1 2
NCT06647069A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic DiseasesSystemic Lupus Erythematosus (SLE)
RECRUITING62 Analytics
NCT06392477A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Relapsed/ Refractory B-Cell Non-Hodgkin LymphomaB-cell Non Hodgkin Lymphoma
RECRUITING96 Analytics
PHASE1RECRUITING
A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases
Systemic Lupus Erythematosus (SLE)
NCT0664706962
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PHASE1RECRUITING
A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Relapsed/ Refractory B-Cell Non-Hodgkin Lymphoma
B-cell Non Hodgkin Lymphoma
NCT0639247796
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Study Endpoints

Primary Endpoints

Incidence of treatment-emergent adverse events (TEAEs)
Baseline to Week 52 (End of Study (EOS))
Incidence of potentially clinically significant abnormalities (PCSAs)
Baseline to Week 52 (EOS)

PCSAs include laboratory parameters; vital signs; and ECG parameters including heart rate, PR, QRS, QT, QTcF.

Incidence of treatment-emergent adverse event (TEAE)
Baseline to 28 days post last dose
Potential pharmacologically optimized dose/regimen(s) of SAR448501 / DR-0201 in participants with R/R B-NHL
Cycle 1 (Day 1 to Day 28)

Potential pharmacologically optimized dose/regimen(s) of SAR448501/DR-0201 in participants with R/R B-NHL as determined using an integrated assessment of efficacy, safety, pharmacokinetic (PK)/pharmacodynamic (PD), and exposure-response relationships

Secondary Endpoints

Assessment of pharmacokinetic (PK) parameters: AUC0-t
Baseline to Week 20
Assessment of pharmacokinetic (PK) parameters: Cmax
Baseline to Week 20
Assessment of pharmacokinetic (PK) parameters: Ctrough
Baseline to Week 20
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SAR448501 dose escalationEXPERIMENTALSAR448501 will be administered for up to 71 days. Different cohorts with up to 7 dose levels will be included.

Interventions

NameTypeDescription
SAR448501DRUGBispecific antibody
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Diagnosis of SLE and/or RA. American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria should be used. * Contraception during the study intervention period and for at least 140 days after the last administration of study intervent...

Countries:AustraliaBosnia and HerzegovinaNew ZealandSouth AfricaSerbiaSingaporeSouth KoreaTaiwan
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Frequently asked questions about SAR448501

What is SAR448501 used for?

SAR448501 is an investigational small molecule being studied for B-cell Non-Hodgkin Lymphoma and Systemic Lupus Erythematosus (SLE). It is also being evaluated in autoimmune rheumatic diseases, including Rheumatoid Arthritis. The drug is in Phase 1 clinical development and is not yet approved.

What does SAR448501 target?

SAR448501 targets myeloid cells, a type of immune cell. By acting on these cells, the drug is being studied for its potential effects in oncology and autoimmune conditions. Its exact mechanism of action is under investigation in early-stage clinical trials.

Who is developing SAR448501?

SAR448501 is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. The drug is currently in Phase 1 clinical trials, with studies recruiting participants in multiple countries.

What phase is SAR448501 in?

SAR448501 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trials are evaluating its safety and activity in patients with B-cell Non-Hodgkin Lymphoma and autoimmune rheumatic diseases.

What clinical trials is SAR448501 in?

SAR448501 is being studied in two Phase 1 clinical trials. One trial, NCT06392477, is evaluating the drug in patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma. Another trial, NCT06647069, is studying it in patients with Systemic Lupus Erythematosus and Rheumatoid Arthritis. Both trials are currently recruiting.

Is SAR448501 the same as DR-0201?

Yes, SAR448501 is also known as DR-0201. Clinical trial records refer to the drug as SAR448501/DR-0201. This alternative name is used in studies evaluating the drug for B-cell Non-Hodgkin Lymphoma and autoimmune rheumatic diseases.