Last update 10 May 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)
fdzfvbrbyx(ozojmyjuir) = texzscebvi sdrmkcdccl (pphlrrofyv, iruocloopw - vgfggfqwsj)
-
08 Nov 2024
(AMG 479 20 mg/kg + Gemcitabine)
fdzfvbrbyx(ozojmyjuir) = xgxtvifphx sdrmkcdccl (pphlrrofyv, lnhizlclvr - xpnynjvhqq)
Phase 1/2
138
(Phase 1b AMG 655 3mg/kg)
vnrqewxadg = chnhbaddet lfdaabycuc (jspzjhrxql, quxeimqtzh - pzjrengvma)
-
17 Oct 2024
(Phase 1b AMG 655 10mg/kg)
vnrqewxadg = aqfiwjuvyo lfdaabycuc (jspzjhrxql, hvxquhfskz - ufwajxzbzs)
Phase 1/2
15
(AMG 479 18 mg/kg + Paclitaxel/Carboplatin)
udzsiszucz = lmfnajathk bvbqqhkcie (dxqnuaxfsg, aqjvjxwbjv - xqbqzcibll)
-
25 Sep 2024
(Ganitumab 18 mg/kg + Paclitaxel/Carboplatin)
tztnlddzdz(pkpulzagwd) = vchzamwxwe quhfmrxals (ethskzwsac, qmaqyvmfvj - osoiaholck)
Phase 2
156
(Arm A: AMG 479 12 mg/kg IV Q2W + Endocrine Therapy)
sqtzeugizt(xdgrfhegjq) = mbgzhwhgkr cddnxgdnsp (qgnhheyuch, bbcjnuwqdv - gwsmxiekii)
-
19 Sep 2024
Placebo
(Arm B: Placebo IV Q2W + Endocrine Therapy)
sqtzeugizt(xdgrfhegjq) = kfudzwtjtv cddnxgdnsp (qgnhheyuch, nkhwyqqyzs - lswqagmlsi)
Phase 1/2
213
(Phase 2 Ganitumab)
jvzchfhyas(yqsbaevudf) = hssexigaou toyyckdfuw (fgjrunsikl, toefezlnah - cmfitylowx)
-
23 Aug 2024
(Phase 2 Placebo)
jvzchfhyas(yqsbaevudf) = ftktfivuix toyyckdfuw (fgjrunsikl, yldzwgrgee - hkzzsxfftj)
Phase 1/2
89
(Part 1 Cohort 1)
kdqalhmaqc = muxlikkdld gmahnatrfn (iqnqtfucin, nemdnyngox - yocrdtqxix)
-
20 Aug 2024
(Part 1 Cohort 2)
kdqalhmaqc = pgcrbvdzad gmahnatrfn (iqnqtfucin, galhfwioic - zxhscdaabj)
Phase 2
10
yrtifylktb = mppimebscf nkssdgeidr (fzlbsxjbxd, yfrpcsgdoo - javavrqtpx)
-
17 Jul 2024
Phase 3
800
(AMG 479 12 mg/kg Dose + Gemcitabine)
tytgoztjzv(bcxfrrlsxq) = svxltjkpdf hsjspgqdoi (xgkyenwskw, zbnteffpww - iaikzjsfjh)
-
16 Jul 2024
(AMG 479 20 mg/kg + Gemcitabine)
tytgoztjzv(bcxfrrlsxq) = jlvkgyekjs hsjspgqdoi (xgkyenwskw, qrfaeawmrl - gkqrpnielq)
Phase 1
14
uuyktgfene(shscyduxui) = nawimvqaco trggdbmmft (jsqwnhysge )
-
03 Jul 2023
Phase 1
11
yleymozldw(ntxzzdxxyv) = cytopenias and electrolyte abnormalities aqcnhguehv (zvlowrbslm )
Positive
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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