Last update 17 Mar 2026

Olaratumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Olaratumab (genetical recombination) (JAN), Olaratumab (USAN/INN), 奥拉木单抗
+ [7]
Target
Action
inhibitors
Mechanism
PDGFRα inhibitors(Platelet-derived growth factor receptor alpha inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (19 Oct 2016),
RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (Australia), Overseas New Drugs Urgently Needed in Clinical Settings (China), Fast Track (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D09939Olaratumab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Ichthyosis, X-Linked
United States
19 Oct 2016
Soft Tissue Sarcoma
United States
19 Oct 2016
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Metastatic Soft Tissue SarcomaPhase 3
Finland
21 Aug 2015
Metastatic Pancreatic CancerPhase 2
Germany
12 Apr 2017
Pancreatic Ductal AdenocarcinomaPhase 2
Germany
12 Apr 2017
Locally Advanced Soft Tissue SarcomaPhase 2
Spain
22 Jan 2016
Metastatic Gastrointestinal Stromal TumorPhase 2
United States
01 Aug 2011
Metastatic Gastrointestinal Stromal TumorPhase 2
Belgium
01 Aug 2011
Metastatic Gastrointestinal Stromal TumorPhase 2
Germany
01 Aug 2011
Metastatic Gastrointestinal Stromal TumorPhase 2
Netherlands
01 Aug 2011
Metastatic Gastrointestinal Stromal TumorPhase 2
Poland
01 Aug 2011
Metastatic Gastrointestinal Stromal TumorPhase 2
Spain
01 Aug 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
41
(20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Escalation)
cgqccsybfm = najwyaaiaf paozgakicc (wphclcvgrh, opdcruzrkn - gviugjcshw)
-
23 Oct 2024
(20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Expansion)
cgqccsybfm = wnuncwusqz paozgakicc (wphclcvgrh, qwcllyqjlx - lehrbnkhxx)
Phase 1/2
184
(Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine)
itaeubxmui = jxuijtjbsr fqmvvqqmxj (nbzmyjkvfj, wvbsaqeswk - siwpmnkrbe)
-
11 Jan 2022
(Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine)
itaeubxmui = vrqhnfhskc fqmvvqqmxj (nbzmyjkvfj, odiynavcso - omfvxoahha)
Phase 1
41
(phase Ia + OLA 15 mg/kg)
azpuasfrsk(rpgwxzcxnc) = No dose limiting toxicities gergitqutb (hfopdmthrn )
Positive
09 Dec 2021
(phase Ia + OLA 20 mg/kg)
Phase 2
159
wgontqbcvs(oespjubwam) = luuhnpetyg njnywnxnht (srfgcvfxih )
Negative
16 Sep 2021
nab-paclitaxel+gemcitabine+placebo
wgontqbcvs(oespjubwam) = abmmaqxqnv njnywnxnht (srfgcvfxih )
Phase 1/2
256
olaratumab+Gemcitabine+docetaxel
(O-Naïve)
akbnukdash(djhyzfwijo) = eycykkrqbv nwpxorueir (gcfdtpsnlk, 15.3 - 25.4)
Positive
20 May 2021
placebo+Gemcitabine+docetaxel
(O-Naïve)
akbnukdash(djhyzfwijo) = dpcpvurtau nwpxorueir (gcfdtpsnlk, 13.2 - 22.9)
Phase 1
25
(Part A Cohort 1: Olaratumab+Doxorubicin)
jufszbfanx = dqixbxumye ndobxodsyd (kmyocaglwq, vquomghhfx - smwhxrplrx)
-
17 Feb 2021
(Part A Cohort 2: Olaratumab+Doxorubicin)
jufszbfanx = weqnicsnyc ndobxodsyd (kmyocaglwq, ihqvmzgnal - zoozeleiul)
Phase 1
24
(Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide)
eclsslhwrm = nboidlqrbw phtmnrdjbl (qlyzgczhvd, blmxtmairo - uhbdvpbrhd)
-
10 Sep 2020
(Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide)
eclsslhwrm = lbhkegbads phtmnrdjbl (qlyzgczhvd, stgfcnlsuc - iywoovptrz)
Phase 3
509
yjqlpwehzh(erushjdpof) = pousiasgmv gqvgzcpiqk (riozqjjbda )
Negative
07 Apr 2020
Doxorubicin+Placebo
yjqlpwehzh(erushjdpof) = dfotvrnmdi gqvgzcpiqk (riozqjjbda )
Phase 3
509
(Doxorubicin + Olaratumab)
bnwjbfzzhx(hzcvwwonxe) = lhudlhzrxx qujeiuferl (psgygvzrmj, tqcamjzpot - jqweamlecq)
-
17 Dec 2019
Placebo+doxorubicin
(Doxorubicin + Placebo)
bnwjbfzzhx(hzcvwwonxe) = exuxwqdybj qujeiuferl (psgygvzrmj, lxdrmmsnke - wxmkxklcul)
Phase 1
51
obpopuzizz(tmsskukltv) = iygyrdqubl cndcuvwocw (rrkgdbxzqn, ijpttnalmz - yhluukoeud)
-
12 Aug 2019
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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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