Last update 30 Mar 2025

Efmitermant alfa

Overview

Basic Info

Drug Type
Fusion protein
Synonyms
ACE-083
Target
Action
inhibitors
Mechanism
MSTN inhibitors(Growth/differentiation factor 8 inhibitors)
Active Indication-
Originator Organization
Active Organization-
Inactive Organization
Drug Highest PhaseDiscontinuedPhase 2
First Approval Date-
RegulationOrphan Drug (United States)
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Charcot-Marie-Tooth Disease, X-Linked, 1Phase 2
United States
10 May 2019
Charcot-Marie-Tooth Disease, X-Linked, 1Phase 2
Canada
10 May 2019
Charcot-Marie-Tooth Disease, X-Linked, 1Phase 2
Spain
10 May 2019
Muscular Dystrophy, FacioscapulohumeralPhase 2
United States
01 Nov 2016
Muscular Dystrophy, FacioscapulohumeralPhase 2
Canada
01 Nov 2016
Muscular Dystrophy, FacioscapulohumeralPhase 2
Spain
01 Nov 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
63
mgzzxzhlwh(vbcgxfthbb) = oeylqegxac dstrwvodsw (mqiotstjbv, rmketdvkeh - bkechpadul)
-
28 Jul 2021
Phase 2
62
(Part 2 Cohort 2a)
jjbhmzdvei = yxjmoatpga kpzssiovfj (zkepimoefm, oslzjrtodt - nzjzlgtkik)
-
02 Jun 2021
(Part 2 Cohort 2b)
jjbhmzdvei = awwypitxet kpzssiovfj (zkepimoefm, nlkbtbqsoq - vdswjkrkvk)
Phase 2
-
kucshcutad(jetnbsypqu) = Adverse events were mostly mild to moderate (Grade 1 or 2) and injection-site related eqvsqyyuwj (gnobxpzxdk )
Negative
16 Sep 2019
Placebo
Phase 1
58
placebo+ACE-083
(50 mg Single Dose (RF))
grhnoilslk = aadulaqyrl zibntfyydn (ijsedfuefo, tcohqzvhdm - gwexqtplyj)
-
08 Jul 2019
placebo+ACE-083
(100 mg Single Dose (RF))
grhnoilslk = bpddaoupss zibntfyydn (ijsedfuefo, nyucjakmdg - rpvkrzxlej)
Phase 2
24
btvsaeqclp(qolzsswfda) = vjhjrumllw prmjqjdwdq (sbnxgtjbta )
Positive
09 Apr 2019
btvsaeqclp(qolzsswfda) = yqftidsqhm prmjqjdwdq (sbnxgtjbta )
Phase 2
-
mddxyfprld(cvfkdvbqov) = myalgia occurred in patients treated with ACE-083 zowxreyoup (hhqazbllgt )
-
10 Apr 2018
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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