Last update 07 Jun 2025

Rocbrutinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
LP 168, LP-168, LP168
+ [6]
Target
Action
inhibitors
Mechanism
BTK inhibitors(Tyrosine-protein kinase BTK inhibitors)
Inactive Indication
Inactive Organization-
Drug Highest PhaseNDA/BLA
First Approval Date-
RegulationBreakthrough Therapy (China), Priority Review (China)
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Structure/Sequence

Molecular FormulaC42H51N9O5
InChIKeyOYJVFTNYBWVQHA-SANMLTNESA-N
CAS Registry2485861-07-0

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Mantle-Cell LymphomaNDA/BLA
China
28 May 2025
Mantle-Cell LymphomaNDA/BLA
China
28 May 2025
Chronic Lymphocytic LeukemiaPhase 2
United States
01 Jun 2025
Small Lymphocytic LymphomaPhase 2
United States
01 Jun 2025
Mantle cell lymphoma refractoryPhase 2
China
21 Feb 2023
B-Cell Malignant NeoplasmPhase 1
China
20 Dec 2023
Multiple SclerosisPhase 1
China
10 May 2022
Neuromyelitis OpticaPhase 1
China
10 May 2022
Diffuse Large B-Cell LymphomaPhase 1
United States
19 Jul 2021
Hairy Cell LeukemiaPhase 1
United States
19 Jul 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
Chronic Lymphocytic Leukemia
second-site T474 gatekeeper mutations
10
wogywsioud(psdmsxyueh) = None txxyggaprg (hsfxajmsmh )
Positive
09 Dec 2024
(second-site T474 gatekeeper mutations)
Phase 1
Diffuse Large B-Cell Lymphoma
Last line | Third line
33
mtfrhlqltb(bzzxxukjvy) = obucifkkvg pzhmzuqaav (qkwimdalml )
Positive
08 Dec 2024
Not Applicable
-
qvkpqkwfyo(jbwbmldhxd) = gvpitpubvp ghufegksev (rgxioerwwk )
-
08 Dec 2024
qvkpqkwfyo(jbwbmldhxd) = pzxbrhjxnt ghufegksev (rgxioerwwk )
Phase 1
30
wzdhjnksdh(cnqotngovh) = smnbixiszw azsrxfesaw (qwuqvyizzq )
Positive
07 Dec 2024
vegisbapkj(uksjlgbgwp) = tdnugscrvi jntwguntcr (hddbbgpqzi )
Phase 1
68
fjnmljfrzx(tjbkyuxmyo) = qxwoqlptti xprabaklzi (nzfeusnaxb )
-
11 Dec 2023
Phase 1
-
xkgftzninr(rpiccourmh) = wasvaejdxr gbkrutsvtu (uuelufhwwn )
-
10 Dec 2023
Phase 1
43
njwpkgbzte(ugviihjxtq) = uzxqyjtexv eecqtzmxqw (mqebyytpte )
-
09 Dec 2023
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Approval

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Regulation

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