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Teriflunomide HMR1726

Phase 3

Multiple Sclerosis | Small molecule | Neurology |Sanofi|Last Updated: Mar 13, 2015

Success Probability

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Trial Design

NO_TREATMENT_CONTROLLED
Total Trials2
Total Enrollment82

FDA Designations

No designations recorded

Clinical trial landscape

Teriflunomide HMR1726 · 3 trials · 2 indications

Phase 3 1Phase 1 2
NCT01863888Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple SclerosisMultiple Sclerosis
COMPLETED70 Analytics
PHASE3COMPLETED
Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple Sclerosis
Multiple SclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in Lymphocyte subset parameters as measured by flow cytometry
At 12 weeks and 24 weeks
Pharmacokinetic parameters for teriflunomide determined from plasma concentration
5 weeks
Pharmacokinetic parameters of Teriflunomide determined from plasma concentration (Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUC))
56 days

Secondary Endpoints

Change from baseline in biased T cell clonal repertoire based T cell receptor (TCR) spectratyping
At 12 weeks and 24 weeks
Change from baseline in serum cytokine as measured by multicytokine array tool
At 12 weeks and 24 weeks
Change from baseline in Mitogen/TCR-specific T cell proliferation as measured by flow cytometry
At 12 weeks and 24 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
teriflunomide (HMR1726)EXPERIMENTALParticipants administered 14mg Teriflunomide once daily, oral. For participants who permanently discontinue Teriflunomide, an accelerated elimination procedure with either cholestyramine or charcoal will be administered.
Reference populationNO_INTERVENTIONUntreated healthy subjects
teriflunomide dose 1EXPERIMENTALTeriflunomide 14mg tablet, oral single dose, fast condition Cholestyramine power, 8 gram,oral three times a day for 4 days, fed condition
Severe impaired renal functionEXPERIMENTALSubjects with severe renal impairment as defined by Cockroft-Gault formula
Normal renal functionEXPERIMENTALSubjects with normal renal function as defined by Cockroft-Gault formula

Interventions

NameTypeDescription
teriflunomide HMR1726DRUGPharmaceutical form:tablet Route of administration: oral
cholestyramineDRUGPharmaceutical form:powder Route of administration: oral
charcoalDRUGPharmaceutical form:granule Route of administration: oral
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites10

Inclusion criteria: Patients (male and female) with relapsing forms of multiple sclerosis meeting McDonald criteria for MS at the screening visit and having either one of the following treatment status: * Naïve to disease modifying (DM) treatment or no DM treatment for more than 2 years * Or curre...

Countries:BelgiumGermanyNetherlandsChina
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Frequently asked questions about Teriflunomide HMR1726

What is Teriflunomide HMR1726 used for?

Teriflunomide HMR1726 is an investigational small molecule being developed by Sanofi for multiple sclerosis and renal impairment. It is currently in Phase 3 clinical development. The drug is being studied for its effects on immune cell subsets in multiple sclerosis patients and for pharmacokinetics in subjects with severe renal impairment.

Who makes Teriflunomide HMR1726?

Teriflunomide HMR1726 is developed by Sanofi, a company traded under the ticker SNY. Sanofi is conducting clinical trials to evaluate the drug's safety and efficacy in multiple sclerosis and renal impairment. The drug is currently in Phase 3 development.

What phase is Teriflunomide HMR1726 in?

Teriflunomide HMR1726 is in Phase 3 clinical development. It is an investigational drug, not yet approved by regulatory authorities. Sanofi has completed two clinical trials involving the drug, including a Phase 3 study in multiple sclerosis patients.

What clinical trials is Teriflunomide HMR1726 in?

Teriflunomide HMR1726 has been studied in two completed trials. NCT01239459 evaluated a single 14 mg dose in subjects with severe renal impairment. NCT01863888 examined its effect on immune cell subsets in multiple sclerosis patients. Both trials are completed, with no active trials currently ongoing.

Is Teriflunomide HMR1726 the same as Teriflunomide?

Teriflunomide HMR1726 is a specific investigational formulation of teriflunomide being developed by Sanofi. While teriflunomide is a known medication for multiple sclerosis, this particular drug candidate is still in clinical development and has not been approved. It is being studied for use in multiple sclerosis and renal impairment.