Diroximel Fumarate ( DrugBank: Diroximel fumarate )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
13多発性硬化症/視神経脊髄炎5

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,340 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
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PhaseCountries
1NCT05658497
(ClinicalTrials.gov)
January 20, 202312/12/2022Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)Vumerity (Diroximel Fumarate) Prospective MS Pregnancy Exposure RegistryMultiple SclerosisDrug: Diroximel Fumarate;Drug: Avonex;Biological: Tysabri;Drug: Dimethyl FumarateBiogenNULLNot yet recruitingN/AN/AFemale454NULL
2JPRN-jRCT2051210115
09/12/202129/10/2021A Study of Diroximel Fumarate (DRF) in Adult Participants from the Asia-Pacific Region with Relapsing Forms of Multiple Sclerosis (RMS)An Open-Label, Single-Arm, Multicenter, Phase 3 Study to Evaluate the Safety and Tolerability, and Pharmacokinetics of Diroximel Fumarate (BIIB098) in Adult Participants From the Asia-Pacific Region With Relapsing Forms of Multiple Sclerosis Relapsing Forms of Multiple Sclerosis (RMS)Research Name: BIIB098 (also known as ALK8700)
Generic Name: Diroximel Fumarate (DRF)
Trade Name: Vumerity
Participants will initiate treatment with DRF 231 mg twice daily on Day 1 through Day 7, followed by 462 mg twice daily from Day 8 onwards.
Hanna Jerome ThomasNULLRecruiting>= 18age old<= 65age oldBoth100Phase 3China;Japan
3NCT05688436
(ClinicalTrials.gov)
September 24, 20219/1/2023A Study to Assess Pregnancy Outcomes in Women Exposed to Diroximel FumaratePregnancy Outcomes in Women Exposed to Diroximel FumarateMultiple SclerosisDrug: Diroximel Fumarate;Biological: Alemtuzumab;Drug: Fingolimod;Drug: Glatiramer acetate;Biological: Interferon beta;Biological: Natalizumab;Biological: Ocrelizumab;Biological: Peginterferon beta-1a;Drug: SiponimodBiogenNULLRecruiting18 Years49 YearsFemale825United States
4EUCTR2017-001294-16-DE
(EUCTR)
18/02/201907/11/2018A Phase 3 Study in Subjects with Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl FumarateA Phase 3 Study in Subjects with Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate Relapsing-Remitting Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: N/A
Product Code: ALKS 8700 Delayed Release (DR)
INN or Proposed INN: Not available
Other descriptive name: Diroximel fumarate
Trade Name: Tecfidera® 120 mg
Product Name: Tecfidera® 120 mg
INN or Proposed INN: Tecfidera
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Tecfidera® 240 mg
Product Name: Tecfidera® 240 mg
INN or Proposed INN: Tecfidera
Other descriptive name: DIMETHYL FUMARATE
Alkermes, Inc.NULLNot Recruiting Female: yes
Male: yes
500 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Poland;Germany
5EUCTR2017-001294-16-PL
(EUCTR)
22/09/201729/06/2017A Phase 3 Study in Subjects with Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl FumarateA Phase 3 Study in Subjects with Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate Relapsing-Remitting Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: N/A
Product Code: ALKS 8700 Delayed Release (DR)
INN or Proposed INN: Not available
Other descriptive name: Diroximel Fumarate (DRF)
Trade Name: Tecfidera® 120 mg
Product Name: Tecfidera® 120 mg
INN or Proposed INN: Tecfidera
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Tecfidera® 240 mg
Product Name: Tecfidera® 240 mg
INN or Proposed INN: Tecfidera
Other descriptive name: DIMETHYL FUMARATE
Alkermes, Inc.NULLNot RecruitingFemale: yes
Male: yes
420Phase 3United States;Poland;Germany