Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Teriflunomide HMR1726 · 3 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| teriflunomide (HMR1726) | EXPERIMENTAL | Participants 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 population | NO_INTERVENTION | Untreated healthy subjects |
| teriflunomide dose 1 | EXPERIMENTAL | Teriflunomide 14mg tablet, oral single dose, fast condition Cholestyramine power, 8 gram,oral three times a day for 4 days, fed condition |
| Severe impaired renal function | EXPERIMENTAL | Subjects with severe renal impairment as defined by Cockroft-Gault formula |
| Normal renal function | EXPERIMENTAL | Subjects with normal renal function as defined by Cockroft-Gault formula |
| Name | Type | Description |
|---|---|---|
| teriflunomide HMR1726 | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| cholestyramine | DRUG | Pharmaceutical form:powder Route of administration: oral |
| charcoal | DRUG | Pharmaceutical form:granule Route of administration: oral |
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...
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Teriflunomide HMR1726 is used for the treatment of multiple sclerosis. It has also been studied in people with renal impairment to evaluate its pharmacokinetic profile and tolerability. The clinical development program includes trials in multiple sclerosis and renal impairment, and the drug is being developed by Sanofi.
Teriflunomide HMR1726 targets dihydroorotate dehydrogenase (DHODH) and acts as an inhibitor of this enzyme. DHODH is involved in pyrimidine synthesis, and inhibiting it can affect the proliferation of immune cells. This mechanism is relevant to its development in multiple sclerosis.
Teriflunomide HMR1726 is developed by Sanofi, which trades under the ticker SNY. Sanofi is the company responsible for the clinical development of this small molecule drug candidate.
Teriflunomide HMR1726 has been studied in Phase 3 clinical trials. The development program includes completed Phase 3 and Phase 1 studies. The drug is investigational and has not been approved by the FDA for the studied indications.
Teriflunomide HMR1726 has been evaluated in completed clinical trials including NCT02046629, a Phase 1 pharmacokinetic study in healthy Chinese volunteers, NCT01863888, a Phase 3 study on immune cell subsets in multiple sclerosis patients, and NCT01239459, a Phase 1 pharmacokinetic and tolerability study in subjects with severe renal impairment.