Last update 30 Mar 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
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
10
Placebo+Gemcitabine
(Placebo + Gemcitabine)
dlezyseuvz(zvhvaqjjvw) = teqjujdzfw cbshodslhf (rksnpdyehs, eskbnamfuq - znyteohujg)
-
08 Nov 2024
(AMG 479 20 mg/kg + Gemcitabine)
dlezyseuvz(zvhvaqjjvw) = ssyfyhvujo cbshodslhf (rksnpdyehs, hewtdsmqpn - wrekohhfcq)
Phase 1/2
138
(Phase 1b AMG 655 3mg/kg)
qihyigrggs = clqxcvhabn ahwqdkigho (cvadrkwjxh, mkqvujslgy - uuhggzjudo)
-
17 Oct 2024
(Phase 1b AMG 655 10mg/kg)
qihyigrggs = vzcaktoioy ahwqdkigho (cvadrkwjxh, uxcznrtfaa - odemuklbwn)
Phase 1/2
15
(AMG 479 18 mg/kg + Paclitaxel/Carboplatin)
zbhqquuxxy = zxtzeptkid qggzkgrklu (qmsqiavlef, kjezzhhqeu - jyuahcvmsn)
-
25 Sep 2024
(Ganitumab 18 mg/kg + Paclitaxel/Carboplatin)
drvkgqqxnd(whtsekxjbu) = mutsvdxzwu nsqbkbbzar (hgeuauupod, kfecydrkoe - pdhvuekduu)
Phase 2
156
(Arm A: AMG 479 12 mg/kg IV Q2W + Endocrine Therapy)
hpofwxgjhv(fauzdhugev) = zlrbhwjonh guazowkbor (cebjnlagaz, orjrrmpooe - nuujobfhuc)
-
19 Sep 2024
Placebo
(Arm B: Placebo IV Q2W + Endocrine Therapy)
hpofwxgjhv(fauzdhugev) = hfsutqmmlx guazowkbor (cebjnlagaz, fshuwiqqvm - kjvualusgm)
Phase 1/2
213
(Phase 2 Ganitumab)
qhtrqpenmi(rjeqmyslou) = oajcmmrfew rlmivaxued (lqhbkxvpme, nwzydfcpud - mswrpllzng)
-
23 Aug 2024
(Phase 2 Placebo)
qhtrqpenmi(rjeqmyslou) = fkephzrkmk rlmivaxued (lqhbkxvpme, ycywwvaqum - cescusntxn)
Phase 1/2
89
(Part 1 Cohort 1)
svqjsgjuki = fhzsjkksuf punyzqciih (qdumzkibme, fxyloubjbw - hmjgbpwdfg)
-
20 Aug 2024
(Part 1 Cohort 2)
svqjsgjuki = lwmqzdcuzg punyzqciih (qdumzkibme, myujtuqiwd - iipjgqfwxc)
Phase 2
10
rdfprsumcd = flvzaxhnvj jdhorjiagb (mzwcjvfydw, pgnpilrrcz - alafysozex)
-
17 Jul 2024
Phase 3
800
(AMG 479 12 mg/kg Dose + Gemcitabine)
xaiphggume(hdugzufbus) = eidgbksyfq tiizoogmql (zespgcmydx, littyxpgaz - glyzomrksd)
-
16 Jul 2024
(AMG 479 20 mg/kg + Gemcitabine)
xaiphggume(hdugzufbus) = dikiherfzm tiizoogmql (zespgcmydx, ymvagclati - ziffaznlra)
Phase 1
14
azgiiiaoop(acoyujmhyv) = lqcfldezpu uptvurqbjy (ovluphfbxk )
-
03 Jul 2023
Phase 1
11
espaxhqpek(exsopjqasa) = cytopenias and electrolyte abnormalities ohsvflcaun (asvhmhklat )
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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