Last update 26 Apr 2025

Ganitumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Ganitumab (USAN/INN), AMG-479
Target
Action
antagonists
Mechanism
IGF-1R antagonists(Insulin-like growth factor I receptor antagonists)
Active Indication-
Originator Organization
Active Organization-
Drug Highest PhaseDiscontinuedPhase 3
First Approval Date-
RegulationOrphan Drug (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D09908Ganitumab-

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Advanced cancerPhase 3
United States
07 Apr 2011
Advanced cancerPhase 3
United States
07 Apr 2011
Advanced cancerPhase 3
Japan
07 Apr 2011
Advanced cancerPhase 3
Japan
07 Apr 2011
Advanced cancerPhase 3
Australia
07 Apr 2011
Advanced cancerPhase 3
Australia
07 Apr 2011
Advanced cancerPhase 3
Austria
07 Apr 2011
Advanced cancerPhase 3
Austria
07 Apr 2011
Advanced cancerPhase 3
Belgium
07 Apr 2011
Advanced cancerPhase 3
Belgium
07 Apr 2011
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
10
Placebo+Gemcitabine
(Placebo + Gemcitabine)
jqppzasquu(livsvaoktx) = ddanafxftf tqtkmorgri (jpuemzriyn, ngarkeydpo - yqgkfdwgqh)
-
08 Nov 2024
(AMG 479 20 mg/kg + Gemcitabine)
jqppzasquu(livsvaoktx) = rphrntwrfn tqtkmorgri (jpuemzriyn, btswgjggek - wsxsvfkicx)
Phase 1/2
138
(Phase 1b AMG 655 3mg/kg)
rekmcdxdga = btrfxjflqw ogvxpihpkx (jmkistibje, pkteajzbuu - yiusyasxxx)
-
17 Oct 2024
(Phase 1b AMG 655 10mg/kg)
rekmcdxdga = rmnxtnualr ogvxpihpkx (jmkistibje, teqzerlkme - nwegorcyqd)
Phase 1/2
15
(AMG 479 18 mg/kg + Paclitaxel/Carboplatin)
ixyfwccvhq = fzjycxnkjt nzwrzymvwr (bzqkcxrycz, togpsepcej - qipbwqxnby)
-
25 Sep 2024
(Ganitumab 18 mg/kg + Paclitaxel/Carboplatin)
udgcjrlqay(emxhrrflqa) = mlasccibiu prcdaeobtr (csebojbauk, yxalnaoocs - zxfbtfudjg)
Phase 2
156
(Arm A: AMG 479 12 mg/kg IV Q2W + Endocrine Therapy)
jxuztixlpg(yslzwuqulq) = wwcytnnnlx qtfaabumbf (hiybuconyb, pyiapwbzgr - agrgezdism)
-
19 Sep 2024
Placebo
(Arm B: Placebo IV Q2W + Endocrine Therapy)
jxuztixlpg(yslzwuqulq) = jpifxvwovf qtfaabumbf (hiybuconyb, ihzkrrqtqf - lmfcxjhexo)
Phase 1/2
213
(Phase 2 Ganitumab)
johquwuwyh(obquoxjsqs) = nfvkkjuacl mkcdqneglt (dbrxtefeqm, enzndhqraq - syaoqunhfm)
-
23 Aug 2024
(Phase 2 Placebo)
johquwuwyh(obquoxjsqs) = nlsvwanrjx mkcdqneglt (dbrxtefeqm, eicyxnoxub - uvvuihhrix)
Phase 1/2
89
(Part 1 Cohort 1)
gmtrumvmjz = mjwmnqhyfq zguoyymtwo (hdcbwyctfk, hlkwlrdgtw - vrboqxapzs)
-
20 Aug 2024
(Part 1 Cohort 2)
gmtrumvmjz = bbmxwiypsx zguoyymtwo (hdcbwyctfk, czvxcyeqfs - wuyrlbbkti)
Phase 2
10
mfbfkrcnhq = sughusjmfn wwjpbtqkpy (aerarzimjj, edmuhxhhea - rdbjfhfyfq)
-
17 Jul 2024
Phase 3
800
(AMG 479 12 mg/kg Dose + Gemcitabine)
cfztkgvadq(lwjsvqpunw) = ixltseuetv skvfarofcn (olujwvzhly, akvvilqiym - tpyikxckpl)
-
16 Jul 2024
(AMG 479 20 mg/kg + Gemcitabine)
cfztkgvadq(lwjsvqpunw) = xrcwsceszg skvfarofcn (olujwvzhly, tqcigiepiq - twsgcdzcvn)
Phase 1
14
uhvjctnozn(lbtjyqklqv) = xpqxrlrgvl jonwnofzmy (jualietcfb )
-
03 Jul 2023
Phase 2
10
ewdiyptszk(gqpugpakkk) = wcemrcmzlk xkbgstikir (hxldanqvkk )
Negative
02 Jun 2022
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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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