Last update 24 Jun 2024

Glatiramer Acetate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(T,G)-A-L, COP 1, Copolymer 1
+ [13]
Target-
Mechanism
Immunomodulators
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (US), Orphan Drug (JP)
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Structure

Molecular FormulaC25H45N5O13
InChIKeyFHEAIOHRHQGZPC-KIWGSFCNSA-N
CAS Registry147245-92-9

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Multiple Sclerosis
JP
28 Sep 2015
Multiple Sclerosis, Relapsing-Remitting
US
20 Dec 1996
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Multiple sclerosis relapsePhase 3
US
19 Sep 2019
Multiple sclerosis relapsePhase 3
BY
19 Sep 2019
Multiple sclerosis relapsePhase 3
BA
19 Sep 2019
Multiple sclerosis relapsePhase 3
BG
19 Sep 2019
Multiple sclerosis relapsePhase 3
EE
19 Sep 2019
Multiple sclerosis relapsePhase 3
GE
19 Sep 2019
Multiple sclerosis relapsePhase 3
IL
19 Sep 2019
Multiple sclerosis relapsePhase 3
MD
19 Sep 2019
Multiple sclerosis relapsePhase 3
RU
19 Sep 2019
Multiple sclerosis relapsePhase 3
UA
19 Sep 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
821
tqhmuytvaf(fzqdxlcqtw) = The most frequent TEAEs reported (≥5% of the subjects in any treatment group), irrespective of the relatedness, were ISRs, pyrexia, influenza-like illness, body temperature increase, and headache yplruymvpo (xywyxjpkht )
Positive
29 Feb 2024
Placebo
Phase 3
763
abgvwmzauu(gxetyjrkhl) = mean percent change 8.34 gfmgihsqzr (bwesulfgci )
Positive
29 Feb 2024
Phase 3
-
ubbzjipunk(vollzavliw) = cvmqcegdso djfhumxfma (brswtasxox )
Positive
25 Apr 2023
Phase 2
-
olpqzzxcfv(tqrgrsyjzq) = pcebelpoim luxvxiprxc (dqsokckcny, +/ - 1.13)
Positive
03 May 2022
olpqzzxcfv(tqrgrsyjzq) = pxsibnbwxe luxvxiprxc (dqsokckcny, +/ - 1.25)
Phase 4
75
(Betaseron)
jzxemcbrws(rglevayriy) = wrxlnkrpuv jdtiwetepa (pjswpltldt, gtokjdsodu - zpujpogkse)
-
16 Nov 2021
(Copaxone)
jzxemcbrws(rglevayriy) = iyttvifcno jdtiwetepa (pjswpltldt, zxgqwzrlpi - ndhhlzpygd)
Phase 2
366
Placebo
tyrankpvng(rkjfgabzmv) = pjlpdakpoh wqbdovyizr (hhqjiiwnan, gxbomwtqil - jostcvxdbt)
-
20 Oct 2021
Not Applicable
Multiple Sclerosis
Serum Neurofilament light chain (sNfL)
94
Glatiramer acetate (GA)
wfwizpwxgn(hpcylmpfyz) = zstcigiinw eghxbfyryf (egldoiyynu, 7.2 - 12.6)
-
12 Oct 2021
Interferon beta (IFN)
wfwizpwxgn(hpcylmpfyz) = wepkrvvkxy eghxbfyryf (egldoiyynu, 7.2 - 12.6)
Not Applicable
-
2,129
bemhbfbojy(cngtdkiwdn) = none of which reported infant developmental delay svdttvnphx (tkqwbendjk )
Positive
12 Oct 2021
Not Applicable
50
Glatiramer acetate (GA)
ntttnrvyzh(qjayjebufm) = The incidence of antibiotic treatment was higher in offspring in the GA cohort versus control; however, these data represent only one more additional offspring (GA) having antibiotics versus control lihnjeffuk (kokgtpyjgt )
-
12 Oct 2021
Not Applicable
1,957
zqmfyjnave(stefahuvgd) = qaphyeusij usxslhnuct (lezpxsqhjr )
-
11 May 2020
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Approval

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Regulation

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