Mayzent 2 mg film-coated tablets ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
13Multiple sclerosis/Neuromyelitis optica1

13. Multiple sclerosis/Neuromyelitis optica


Clinical trials : 3,340 Drugs : 2,163 - (DrugBank : 383) / Drug target genes : 241 - Drug target pathways : 238
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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agemax
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PhaseCountries
1EUCTR2020-002700-39-PT
(EUCTR)
03/09/202124/05/2021Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis.A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS Multiple Sclerosis in pediatric patients
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta 20 mg solution for injection in pre-filled pen
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Mayzent 2 mg film-coated tablets
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Trade Name: Mayzent 0.25 mg fi
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Serbia;Portugal;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany