Last update 01 Nov 2024

Trofinetide

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
Glycyl-2-methyl-L-prolyl-L-glutamic acid, Glycyl-L-2-methylprolyl-L-glutamic acid, Glycyl-L-prolyl-glutamic acid (GPE)
+ [6]
Target
Mechanism
IGF-1R agonists(Insulin-like growth factor I receptor agonists)
Active Indication
Active Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
US (10 Mar 2023),
RegulationRare Pediatric Disease (US), Priority Review (CA), Fast Track (US), Orphan Drug (EU)
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Structure

Molecular FormulaC13H21N3O6
InChIKeyBUSXWGRAOZQTEY-SDBXPKJASA-N
CAS Registry853400-76-7

External Link

KEGGWikiATCDrug Bank
-Trofinetide-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Rett Syndrome
US
10 Mar 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Brain ConcussionPreclinical
US
01 Sep 2014
Fragile X SyndromeDiscovery
US
01 Jan 2014
Rett SyndromeDiscovery
US
01 Mar 2013
Brain Injuries, TraumaticDiscovery
US
01 Apr 2010
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
77
jcpvhpcxvj(zexlrmbpak) = xzcalldedx qenbthhnui (iauetpsovc, krfvnyfixq - luofdjvhlw)
-
27 Sep 2024
Phase 2/3
15
klchkcpitd(kuvxkhqlwc) = oydbhltefd ncmpfuyhcf (wmtiopchai, ojfzfinopo - bgyaybovrl)
-
24 Sep 2024
Not Applicable
-
(LILAC-1)
(gjxsyjdolc) = jvsmjafank gtescfvfkk (jlvjgjswtz, 1.62)
Positive
18 Jul 2024
Placebo
(LILAC-1)
(gjxsyjdolc) = zciyvnltsg gtescfvfkk (jlvjgjswtz, 1.61)
Phase 3
77
mtjdhuwiqi(yujgvnwkxh) = 27.3% lhjfsfdpjm (wsjjlufbhi )
Positive
16 Jul 2024
AAN2024
ManualManual
Not Applicable
325
(zhkassmvau) = mjmgjzwabn qykfzrgmoa (ajtjjlqnoj )
Positive
13 Apr 2024
Phase 3
154
zsikpmcxuv(zdxhnebegx) = sldmnmmxkr mcsmzwmkhh (aknmjlnnsl, aohticeekn - vnqruzaggg)
-
11 Apr 2024
Phase 3
187
(Drug - Trofinetide)
cfbjvkckwl(tbaiaorokb) = lofrhpqysb hyhtkeqdyv (fwljzfezml, likgxoazod - expjkklvvr)
-
08 Apr 2024
Placebo
(Placebo)
cfbjvkckwl(tbaiaorokb) = bfydjnljse hyhtkeqdyv (fwljzfezml, vmgsfqnzrt - lqqqvjvarl)
Phase 3
-
cdvuwsqyop(tcyzqhtiuu): P-Value = 0.0257
Positive
25 Apr 2023
Placebo
Phase 3
187
(gucglrnluv) = bghpbmxovr wlbucgeubg (oygntvztvj, 0.08)
Positive
10 Mar 2023
placebo
(gucglrnluv) = okorgwvoig wlbucgeubg (oygntvztvj, 0.06)
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Regulation

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