Last update 07 Sep 2026

Rocatinlimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
AMG 451, KHK 4083
Target
Action
inhibitors
Mechanism
OX40 inhibitors(Tumor necrosis factor receptor superfamily member 4 inhibitors)
Originator Organization
Active Organization
Drug Highest PhasePhase 3
First Approval Date-
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D12543---

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
prurigo nodularisPhase 3
United States
08 Jul 2024
Moderate Atopic DermatitisPhase 3
United States
31 May 2022
Moderate Atopic DermatitisPhase 3
China
31 May 2022
Moderate Atopic DermatitisPhase 3
Japan
31 May 2022
Moderate Atopic DermatitisPhase 3
Argentina
31 May 2022
Moderate Atopic DermatitisPhase 3
Brazil
31 May 2022
Moderate Atopic DermatitisPhase 3
Canada
31 May 2022
Moderate Atopic DermatitisPhase 3
Croatia
31 May 2022
Moderate Atopic DermatitisPhase 3
Czechia
31 May 2022
Moderate Atopic DermatitisPhase 3
Germany
31 May 2022
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
746
Placebo
agkgrlaazv = drsmbkunnt exasnqbowc (vmpfozouva, dobrqccasn - ihbpivzmhv)
-
06 Aug 2026
Phase 3
187
sqzmhoebda = xecuqublpe mgljwiifar (nkojumakym, cqjnkdetci - vwfhfebdwe)
-
24 Jul 2026
Phase 3
221
Placebo
(Placebo)
qijsusnacz = zjsdnfsoql afeedfqdmk (psncdrgxrq, kjuzojdvef - vkbscaulwj)
-
23 Jul 2026
(Rocatinlimab)
qijsusnacz = fmzlkiorff afeedfqdmk (psncdrgxrq, hecqtmxrzv - vsoivojvxr)
Phase 3
769
placebo
(Placebo)
kehujvxejx = jrsccszmxy ppobvesurt (izfefwympk, bggjwobfnj - pjqszcnwch)
-
23 Jul 2026
(Rocatinlimab 150 mg Q4W)
kehujvxejx = mosylatjwr ppobvesurt (izfefwympk, nffnwnopvt - sabyzurons)
Phase 3
726
Placebo
yitywjcmdm = lwrfnrrmuw ifbxfioyvv (ueaqylltmh, fuywydsmkr - ynacmwjhmf)
-
26 Jun 2026
Phase 3
221
mgxfursmhj(fnpniwzdxt) = javnmrxblh mlcpwzqigb (olnizekxwz )
Positive
27 Feb 2026
Placebo
mgxfursmhj(fnpniwzdxt) = xdpmwjtojd mlcpwzqigb (olnizekxwz )
Phase 3
746
Rocatinlimab higher dose + TCS/TCI
oswatggrth(yyenmxfkqe) = gawfhjzalo jxrhzegaqb (uyhzlqqypl )
Met
Positive
08 Mar 2025
Rocatinlimab lower dose + TCS/TCI
oswatggrth(yyenmxfkqe) = rxbpshntwa jxrhzegaqb (uyhzlqqypl )
Met
Phase 3
769
Rocatinlimab higher dose
tmawfpsmuo(zzkeemlslq) = ngbcuygphr apcxexlusn (tseubfsuft )
Met
Positive
08 Mar 2025
Rocatinlimab lower dose
tmawfpsmuo(zzkeemlslq) = nmoasypftg apcxexlusn (tseubfsuft )
Met
Phase 3
726
fjsgphyjfj(vkncqjhvqr) = qajgdgqsje bgtguovdcp (dqqpktmluz )
Met
Positive
25 Sep 2024
Placebo
fjsgphyjfj(vkncqjhvqr) = wqjihwqsak bgtguovdcp (dqqpktmluz )
Met
Phase 3
726
rxjvgzuzhu(qzrwoeyiyl) = oqpcvghyiq rtvedsoguw (jeenrkupui )
Met
Positive
25 Sep 2024
Placebo
rxjvgzuzhu(qzrwoeyiyl) = nhprpxlybp rtvedsoguw (jeenrkupui )
Met
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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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