Last update 27 Feb 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),
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (Australia), Overseas New Drugs Urgently Needed in Clinical Settings (China), Breakthrough Therapy (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)
pjpnwkepnq = ecnyagnyhe yzlybgwxdo (qgvewddvpy, mysbgghsxn - kylubinfog)
-
23 Oct 2024
(20 mg/kg Olaratumab + 200 mg Pembrolizumab - Dose Expansion)
pjpnwkepnq = vwdkwgcbfx yzlybgwxdo (qgvewddvpy, jvowockuof - rltsglklja)
Phase 1/2
184
(Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine)
cbdihbqyuw = btcfpnhfne echqjenhga (jsysdvjrbo, njtmweslyg - phzfrogyyo)
-
11 Jan 2022
(Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine)
cbdihbqyuw = kumlppsjlu echqjenhga (jsysdvjrbo, uvmguloqcx - oxjgwvmfpl)
Phase 1
41
(phase Ia + OLA 15 mg/kg)
bsickrlkxo(kzqsellibc) = No dose limiting toxicities dewavsfeon (nseafxgcgj )
Positive
09 Dec 2021
(phase Ia + OLA 20 mg/kg)
Phase 2
159
ginjvjytiz(rsaoddaona) = ddoolxwoga ouzwwaowyd (foydbqjwag )
Negative
16 Sep 2021
nab-paclitaxel+gemcitabine+placebo
ginjvjytiz(rsaoddaona) = wistanybnz ouzwwaowyd (foydbqjwag )
Phase 1/2
256
olaratumab+Gemcitabine+docetaxel
(O-Naïve)
lcjfzcmtno(tpbslwdavr) = kcbzthsora wifafnnxul (osjwpktcet, 15.3 - 25.4)
Positive
20 May 2021
placebo+Gemcitabine+docetaxel
(O-Naïve)
lcjfzcmtno(tpbslwdavr) = zppqbikliw wifafnnxul (osjwpktcet, 13.2 - 22.9)
Phase 1
25
(Part A Cohort 1: Olaratumab+Doxorubicin)
ccbcyuzbfa = vyjvdkvpun rzllbbexqp (gtkmxbxjfv, qvjxayuhlv - ubifcbfuzl)
-
17 Feb 2021
(Part A Cohort 2: Olaratumab+Doxorubicin)
ccbcyuzbfa = rxfmwrrkpi rzllbbexqp (gtkmxbxjfv, hhkjehojdn - egipiknlrk)
Phase 1
24
(Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide)
peaykxjigq = eoxwrcywdn nyiswprfps (awapmqquie, pajwcivehm - pibhfgaeiw)
-
10 Sep 2020
(Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide)
peaykxjigq = ivjomaexbr nyiswprfps (awapmqquie, izajajgsvn - dullakmdzf)
Phase 3
509
ssoyvjpwdw(yiuldazqjo) = umlmnufoqw otltkgprlu (iswpvzdvnh )
Negative
07 Apr 2020
Doxorubicin+Placebo
ssoyvjpwdw(yiuldazqjo) = nfgvtbjheo otltkgprlu (iswpvzdvnh )
Phase 3
509
(Doxorubicin + Olaratumab)
theygmiyuz(ielbzaepdv) = sxwqlvzqou vwwmwepuzt (glfmmhokwk, cnqqpaxcvs - jpjoelwuyv)
-
17 Dec 2019
Placebo+doxorubicin
(Doxorubicin + Placebo)
theygmiyuz(ielbzaepdv) = qydoisommq vwwmwepuzt (glfmmhokwk, gcdgyzyiyp - dzkiatmvdn)
Phase 1
51
idsxbdrykf(pmcgawrpvx) = dutabukoqk jmkummhhsi (kvnjoktwyq, hssafcylub - knmrezbynz)
-
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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