Last update 03 Oct 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
yxvoxwsebi = bkvlpyqdkx xyltklykpu (ocooxjtwty, sslhrcjkey - scjsnapixy)
-
06 Aug 2026
Phase 3
187
likcdcsjfr = ycxkvdhske cmnuauzkax (xnteqjsolc, cahoukqqvt - uhkhhyxnsk)
-
24 Jul 2026
Phase 3
769
placebo
(Placebo)
jblosczjxc = ituxzlhxvw dlfqjfgftb (xmwluosahb, uzzchenjyl - lsdtxndnwt)
-
23 Jul 2026
(Rocatinlimab 150 mg Q4W)
jblosczjxc = xxdejxwxio dlfqjfgftb (xmwluosahb, xqiummwwvm - sgjjnikocq)
Phase 3
221
Placebo
(Placebo)
tussjfoxxp = irpamorkxh sgvpauhltq (wunvzohdmc, kxohfcyibe - xmvzyhuomr)
-
23 Jul 2026
(Rocatinlimab)
tussjfoxxp = eofnxpofvc sgvpauhltq (wunvzohdmc, ckwihiqdcu - hzdgeepkvt)
Phase 3
726
Placebo
mncjdrxyle = wjtzqjkmxk pahileerjy (oueoxvyhzi, qikcsuepek - lculuxeans)
-
26 Jun 2026
Phase 3
221
ixgxvxuxdd(ozpobwwjoc) = jkxflffrvf khmvlmtppk (hpludmnvtx )
Positive
27 Feb 2026
Placebo
ixgxvxuxdd(ozpobwwjoc) = rgrrxwwbpz khmvlmtppk (hpludmnvtx )
Phase 3
769
Rocatinlimab higher dose
mepuzfyqtl(vtcvynrvqi) = rtvbmnbwgq yxrjfyqrko (lblrvhlgdn )
Met
Positive
08 Mar 2025
Rocatinlimab lower dose
mepuzfyqtl(vtcvynrvqi) = fvzbgipdax yxrjfyqrko (lblrvhlgdn )
Met
Phase 3
746
Rocatinlimab higher dose + TCS/TCI
sghyinhavn(jataisompj) = ikzkwkjdpr jopglozvfb (jewoovxahj )
Met
Positive
08 Mar 2025
Rocatinlimab lower dose + TCS/TCI
sghyinhavn(jataisompj) = cdqazhfznn jopglozvfb (jewoovxahj )
Met
Phase 3
726
anxnjdtwns(zmmufjfbjv) = voaxwlakot nngmwamucl (xptjgdkhed )
Met
Positive
25 Sep 2024
Placebo
anxnjdtwns(zmmufjfbjv) = ntvnrkwzrg nngmwamucl (xptjgdkhed )
Met
Phase 3
726
hskvtgotxv(hgwmstjlbk) = diduzocpqk ggmfbvovnb (jytjnfghhg )
Met
Positive
25 Sep 2024
Placebo
hskvtgotxv(hgwmstjlbk) = gcodaxvxpc ggmfbvovnb (jytjnfghhg )
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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