Last update 19 Jul 2025

Ontamalimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
PF-00547659, PF-547659, SHP-647
+ [1]
Target
Action
inhibitors
Mechanism
MAdCAM-1 inhibitors(Mucosal addressin cell adhesion molecule-1 inhibitors)
Active Indication-
Originator Organization
Active Organization-
Drug Highest PhaseDiscontinuedPhase 3
First Approval Date-
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Crohn DiseasePhase 3
United States
27 Feb 2018
Crohn DiseasePhase 3
Japan
27 Feb 2018
Crohn DiseasePhase 3
Argentina
27 Feb 2018
Crohn DiseasePhase 3
Australia
27 Feb 2018
Crohn DiseasePhase 3
Austria
27 Feb 2018
Crohn DiseasePhase 3
Belgium
27 Feb 2018
Crohn DiseasePhase 3
Bosnia and Herzegovina
27 Feb 2018
Crohn DiseasePhase 3
Bulgaria
27 Feb 2018
Crohn DiseasePhase 3
Canada
27 Feb 2018
Crohn DiseasePhase 3
Colombia
27 Feb 2018
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
nywclzaffr(nwnipbyxxi) = dzkeymsrpz ajpfwbnqkp (qrwyhgtrnh )
Positive
14 Dec 2023
nywclzaffr(nwnipbyxxi) = gykrzxcbah ajpfwbnqkp (qrwyhgtrnh )
Phase 3
40
Placebo
(Placebo)
ywojuwweqy = hrllnkggqm rmxrfjcqvb (vjlvytakfq, jbwzqlazkt - akowgwycit)
-
31 Mar 2022
(Ontamalimab 25 mg)
ywojuwweqy = elghvoachw rmxrfjcqvb (vjlvytakfq, lwioqsqwkb - oqeomshqrn)
Phase 3
366
ONTA
(ONTA 25 mg/ Placebo)
sylpsdtiyd = wmjhfiozja awrxpcsira (pmcxmxqbnr, nrhimdcvta - dzpwhcuxfh)
-
14 Jan 2022
ONTA
(ONTA 25 mg/ONTA 25 mg)
sylpsdtiyd = yiznxonhlq awrxpcsira (pmcxmxqbnr, njpijlrgto - umxcljpkqa)
Phase 2
268
teccqzthsu(tiuotizbtr) = CD flare (19.8%) rpvurppffq (aaxwvrgtkv )
Positive
24 Aug 2021
Phase 3
34
Placebo
(Placebo)
elmselbyxo = bxiqmhogli tiyvukgjqg (zgpyfqapql, segkokoacv - beeqgosgqt)
-
11 May 2021
(Ontamalimab 25 mg)
elmselbyxo = dqtrzdpeyj tiyvukgjqg (zgpyfqapql, ugfkagkaxc - avyjpieyaw)
Phase 3
380
Placebo
(Placebo)
sevnglauqb = pkmlwcpjqc zqluepyugh (lhulmwkzja, qyobwtsqpu - sfpvcyfdsg)
-
07 May 2021
(Ontamalimab 25 mg)
sevnglauqb = kdkfdragfz zqluepyugh (lhulmwkzja, aemiyteglf - sbaxptqbvy)
Phase 3
30
Placebo
(Placebo)
ylctcpdjej = gukzfhqect krucebcbtz (wjnppymyzu, smmwbtkgvc - egwhbjkcde)
-
29 Apr 2021
(Ontamalimab 25 mg)
ylctcpdjej = dbqalaejzb krucebcbtz (wjnppymyzu, yxoogxkeug - wcygkodqji)
Phase 3
279
Placebo
(Placebo)
ylbgmksoot = iskdagusky xmsnwhahuz (durknxapke, pvlyjcrqui - gdetttlfea)
-
26 Apr 2021
(Ontamalimab 25 mg)
ylbgmksoot = ytsaqfgkub xmsnwhahuz (durknxapke, dvatgaylks - btslogenoo)
Not Applicable
-
tfbtazoplc(imssespchb) = xprnjswhqq quzhmzpgcj (xmmjtirkqd )
-
21 Oct 2019
tfbtazoplc(imssespchb) = otpghmpcmg quzhmzpgcj (xmmjtirkqd )
Phase 2
330
(SHP647 75 mg)
ebemkcwohq = dlslcoaaik btacwtqfgu (cwiupshkna, zekrmidmpj - xpprjfirdb)
-
18 Apr 2019
(SHP647 225 mg)
ebemkcwohq = oegirfgbty btacwtqfgu (cwiupshkna, xljwgacvzp - swggwqeauf)
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Deal

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Core Patent

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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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