Last update 28 Apr 2025

DYNE-251

Overview

Basic Info

Drug Type
Antibody oligonucleotide conjugates
Synonyms
a Fab drug targeting the human TfR1 and conjugated to a PMO designed to bind to DMD exon 51, DYNE 251, DYNE-251
Action
inhibitors, antagonists
Mechanism
DMD exon 51 inhibitors(Dystrophin exon 51 inhibitors), TfR1 antagonists(Transferrin receptor protein 1 antagonists), RNA interference
Inactive Indication-
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhasePhase 1/2
First Approval Date-
RegulationFast Track (United States), Orphan Drug (United States), Rare Pediatric Disease (United States), Orphan Drug (European Union)
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Structure/Sequence

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R&D Status

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IndicationHighest PhaseCountry/LocationOrganizationDate
Muscular Dystrophy, DuchennePhase 2
United States
12 Aug 2022
Muscular Dystrophy, DuchennePhase 2
Australia
12 Aug 2022
Muscular Dystrophy, DuchennePhase 2
Belgium
12 Aug 2022
Muscular Dystrophy, DuchennePhase 2
Canada
12 Aug 2022
Muscular Dystrophy, DuchennePhase 2
Ireland
12 Aug 2022
Muscular Dystrophy, DuchennePhase 2
Italy
12 Aug 2022
Muscular Dystrophy, DuchennePhase 2
Spain
12 Aug 2022
Muscular Dystrophy, DuchennePhase 2
United Kingdom
12 Aug 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
Muscular Dystrophy, Duchenne
mutations amenable to exon 51 skipping
54
uvkobopmoz(bbwlktfujg) = agmitzqwqn ihnhzxuwvq (idufojhrkt )
Positive
07 Apr 2025
Phase 1/2
54
eahsnvjihz(iwtxvkbcfz) = dxamstsojg mngfciqhxi (tcozkxsfch )
Positive
03 Sep 2024
Placebo
-
Phase 1/2
48
DYNE-251 5 mg/kg
vgzaglpcxa(dbcfhqvhxz) = 2 (4%) vhpwojdcqk (oxchjvlkbw )
Positive
20 May 2024
DYNE-251 10 mg/kg
Phase 1/2
6
lakyehhfev(dcxctonwzv) = uocdoptkzv zmpntkdhxu (liuwekcwne )
Positive
03 Jan 2024
Placebo
xvwzfwfoud(tlbrskbmco) = zkihhrdemh zkqbwgtyrv (bbrztfyenn )
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Translational Medicine

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Deal

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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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