Teriflunomide
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2012
- First approval year
- 2012
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Teriflunomide
- Molecular weight
- 270.21
- Structure (SMILES)
- C/C(O)=C(\C#N)C(=O)Nc1ccc(C(F)(F)F)cc1
- aubagio
- Aubagio
- teriflunomide accord
- Teriflunomide accord
- teriflunomide mylan
- Teriflunomide mylan
- a77 1726
- A77 1726
- aubagio
- hmr 1726
- HMR-1726
- hmr1726
- HMR1726
- LEFLUNOMIDE IMPURITY B [EP IMPURITY]
- leflunomide impurity b ep impurity
- leflunomide related compound b
- Leflunomide related compound b
- LEFLUNOMIDE RELATED COMPOUND B [USP IMPURITY]
- LEFLUNOMIDE RELATED COMPOUND B [USP-RS]
- leflunomide related compound b rs
- Leflunomide related compound b rs
- leflunomide related compound b usp impurity
- leflunomide related compound b usp rs
- teriflunomida
- Teriflunomida
- teriflunomide
- Teriflunomide
- TERIFLUNOMIDE [EP MONOGRAPH]
- teriflunomide [INN]
- TERIFLUNOMIDE [MI]
- TERIFLUNOMIDE [ORANGE BOOK]
And 10 more, listed on the interactive page.
- ATC classification codes
- L04AK02
Sources for recorded values
- CAS registry numbers
- 163451-81-8
- ChEMBL ID
- CHEMBL973
- InChIKey
- UTNUDOFZCWSZMS-YFHOEESVSA-N
- PubChem compound IDs
- 54684141
- RxNorm IDs (RxCUI)
- 1310520
- FDA ingredient codes (UNII)
- 1C058IKG3B
- Applicant
- SANOFI AVENTIS US
- Approval date
- 12 Sept 2012
- Application number
- NDA202992
- Status
- Authorised
- Status date
- 26 Aug 2013
- Authorisation date
- 26 Aug 2013
- Approved indications
- AUBAGIO is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 for important information on the population for which efficacy has been established).
- Product number
- EMEA/H/C/002514
- Authorisation holder
- Sanofi Winthrop Industrie
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 2
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Multiple Sclerosis
European medicines record
- Patents
- 6
- Designations
- 0
- Earliest recorded loss of exclusivity
- 4 Aug 2034
- First in class
- Yes
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- teriflunomide
- Type
- Synthetic organic
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- dihydroorotate dehydrogenase (quinone)
- Gene symbol
- DHODH
- Protein identifier
- Q02127
- Median affinity
- 6.51
- Affinity units
- pIC50
- Mechanism
- Dihydroorotate dehydrogenase inhibitor
- Action type
- Inhibitor
- Target
- Dihydroorotate dehydrogenase (quinone), mitochondrial
- Protein identifier
- Q02127
Open Targets mechanisms
- Mechanism
- Dihydroorotate dehydrogenase inhibitor
- Action type
- Inhibitor
- Target
- Dihydroorotate dehydrogenase (quinone), mitochondrial
DrugCentral mechanisms
- Action type
- Inhibitor
- Gene symbol
- DHODH
- Protein identifier
- Q02127
- Organism
- Homo sapiens
- Target development level
- Clinical
- Condition
- Celiac Disease
- Highest recorded phase
- 1
- Condition identifier
- EFO:0001060
- Subject identifier
- D002446
- Condition
- Kidney Diseases
- Highest recorded phase
- 1
- Condition identifier
- EFO:0003086
- Subject identifier
- D007674
- Condition
- Multiple Sclerosis, Relapsing-Remitting
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003929
- Subject identifier
- D020529
- Condition
- Purpura, Thrombocytopenic, Idiopathic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0007160
- Subject identifier
- D016553
- Condition
- Paraparesis, Tropical Spastic
- Highest recorded phase
- 1
- Condition identifier
- EFO:0007527
- Subject identifier
- D015493
- Condition
- Multiple Sclerosis, Chronic Progressive
- Highest recorded phase
- 3
- Condition identifier
- EFO:0008522
- Subject identifier
- D020528
- Condition
- Multiple Sclerosis
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0005301
- Subject identifier
- D009103
- Condition identifier
- EFO_0000685
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001060
- Condition identifier
- EFO_0003086
- Highest recorded phase
- 1
- Condition identifier
- EFO_0003929
- Condition identifier
- EFO_0004197
- Highest recorded phase
- 1
- Condition identifier
- EFO_0007160
- Highest recorded phase
- 2
- Condition identifier
- EFO_0007527
- Condition identifier
- EFO_0011052
- Condition identifier
- MONDO_0000450
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0001336
- Condition identifier
- MONDO_0001336
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005301
- Condition identifier
- MONDO_0005301
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005314
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005344
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0008039
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0008383
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0008558
- Highest recorded phase
- 2
- Warning
- Black Box Warning
- Effect
- hepatotoxicity
- Warning
- Black Box Warning
- Effect
- teratogenicity
- Warning
- Black Box Warning
- Effect
- hepatotoxicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- teratogenicity
- Country
- United States
- Event
- alopecia
- Reports
- 826
- Reporting signal score
- 1,617.59
- Event
- balance disorder
- Reports
- 124
- Reporting signal score
- 89.937
- Event
- diarrhoea
- Reports
- 706
- Reporting signal score
- 290.606
- Event
- gait disturbance
- Reports
- 223
- Reporting signal score
- 135.682
- Event
- hepatic enzyme increased
- Reports
- 139
- Reporting signal score
- 100.999
- Event
- hypoaesthesia
- Reports
- 349
- Reporting signal score
- 367.144
- Event
- multiple sclerosis
- Reports
- 210
- Reporting signal score
- 402.029
- Event
- multiple sclerosis relapse
- Reports
- 497
- Reporting signal score
- 1,085.17
- Event
- paraesthesia
- Reports
- 397
- Reporting signal score
- 425.251
- NCT00134563
- NCT00228163
- NCT00475865
- NCT00489489
- NCT00622700
- NCT00751881
- NCT00803049
- NCT00811395
- NCT00883337
- NCT01252355
- NCT01403376
- NCT01487096
- NCT01863888
- NCT01895335
- NCT01970410
- NCT02046629
- NCT02201108
- NCT02425644
- NCT02587195
- NCT02792218
- NCT03122652
- NCT03277248
- NCT03277261
- NCT03856619
- NCT04056897
And 19 more, listed on the interactive page.
- Dose
- 7 mg or 14 mg
- Route
- Oral
- How often
- Once daily
Conditions of use
- Take with or without food
- Hydrogen bond acceptors
- 3
- Hydrogen bond donors
- 2
- Polar surface area
- 73.12
- Calculated partition coefficient (ALogP)
- 3
- Calculated partition coefficient (XLogP)
- 3.3
- Prodrug
- No
- Chirality
- Achiral
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 2
- Heavy atoms
- 19
- Molecular formula
- C12H9F3N2O2
- Monoisotopic mass
- 270.06161202
- Natural product
- No
- 0378-0627
- 0378-0628
- 0480-3156
- 0480-3157
- 16729-399
- 16729-400
- 31722-246
- 31722-247
- 42291-830
- 42291-831
- 46708-313
- 46708-314
- 59651-054
- 59651-055
- 62332-313
- 62332-314
- 68462-423
- 68462-424
- 69339-169
- 69339-170
- 69539-032
- 69539-033
- 69539-315
- 69539-316
- 70377-017
And 9 more, listed on the interactive page.
- Recorded assays
- 321
- Active assays
- 56
- Confirmatory
- Other
- Anti-Inflammatory Agents, Non-Steroidal
- Immunosuppressive Agents
Solubility
- Median
- 2,692,000
- Mean
- 2,692,000
- Minimum
- 2,692,000
- Maximum
- 2,692,000
- Unit
- nM
- Assays
- 2
- Standard deviation
- 0
- Summary method
- median
- Censored results excluded
- 0
- Other units excluded
- 0
- Unknown units excluded
- 0
Measurement types
- Solubility
Related records
Trials (56)
- A Prospective Randomized Non-inferiority Trial Comparing Anti-CD20 Maintenance Versus De-Escalation Strategy In Relapsing-Remitting Multiple Sclerosis
- A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis
- A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
- A Study to Evaluate the Pharmacokinetic Profiles of Single 14 mg Teriflunomide Tablet in Healthy Chinese Volunteers
- A Study to Evaluate the Safety of Long Term Treatment With Teriflunomide 14 mg Once Daily in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis in a Long-term Extension Period
- A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.
- An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis
- An International, Multicenter, Randomized, Double-Blind, Double-Masked Study of the Efficacy and Safety of BCD-132 (JSC BIOCAD, Russia) Using an Active Reference Drug (Teriflunomide) for the Treatment of Patients With Multiple Sclerosis
- An Observational Study on Teriflunomide-exposed Pregnancies
- Biomarkers and Disease Activity in Patients Treated With Teriflunomide (Aubagio)
- Comparative Study of the Efficacy and Safety of BCD-132 With Teriflunomide and Placebo in Multiple Sclerosis
- Czech Pharmaco-epidemiological Study on Disease Modifying Drugs
- Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple Sclerosis
- Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis
- Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis.
- Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-1)
- Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-2)
- Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis and Treated With Interferon-beta
- Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis
- Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis
Approved for (2)
In development for (7)
- Autoimmune thrombocytopenic purpura Phase 2
- Celiac disease Phase 1
- Hepatitis B virus infection Phase 1
- Kidney disorder Phase 1
- Rheumatoid arthritis Phase 3
- Secondary progressive multiple sclerosis Phase 3
- Tropical spastic paraparesis Phase 1
Other linked conditions (1)
- Familial hyperlipidemia
Targets (1)
- DHODH Dihydroorotate dehydrogenase inhibitor