Last update 21 Nov 2024

Orelabrutinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Obrutinib, abutinib
+ [2]
Target
Mechanism
BTK inhibitors(Tyrosine-protein kinase BTK inhibitors)
Drug Highest PhaseApproved
RegulationConditional marketing approval (CN), Special Review Project (CN), Breakthrough Therapy (US), Orphan Drug (US), Priority Review (CN)
Login to view timeline

Structure

Molecular FormulaC26H25N3O3
InChIKeyMZPVEMOYADUARK-UHFFFAOYSA-N
CAS Registry1655504-04-3

External Link

KEGGWikiATCDrug Bank
--

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
Marginal Zone B-Cell Lymphoma
CN
17 Apr 2023
Chronic Lymphocytic Leukemia
CN
25 Dec 2020
Mantle-Cell Lymphoma
CN
25 Dec 2020
Small Lymphocytic Lymphoma
CN
25 Dec 2020
Developing
10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
Waldenstrom MacroglobulinemiaNDA/BLA
CN
14 Mar 2022
Multiple Sclerosis, Primary ProgressivePhase 3
US
08 Sep 2024
Mantle-Cell LymphomaPhase 3-25 May 2024
Primary thrombocytopeniaPhase 3
CN
27 Oct 2023
Chronic idiopathic thrombocytopenic purpuraPhase 3
CN
26 Oct 2023
Purpura, Thrombocytopenic, IdiopathicPhase 3
CN
16 Oct 2023
Macular Dystrophy, Corneal Type 1Phase 3
CN
02 Nov 2022
Mediastinal large B-cell lymphomaPhase 3
CN
02 Nov 2022
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
ypwzffcncq(xrznktvlzw) = 82.3% (14/17) had adverse events, most grade 1 and 2, including leukopenia, anemia, pneumonia, thrombocytopenia, and hematuria. Grade 3 and above adverse events were 11.8% (2/17), manifested as leukopenia. qqkgtzjrcx (kxltenaaxq )
-
09 Dec 2024
Rituximab
Not Applicable
-
jizgjzjwnd(nnmzqaxnvq) = No grade III-IV hematological adverse events were observed in all patients zxawrfvpnt (hqvcqqrbpj )
-
09 Dec 2024
Not Applicable
-
(scufqkqmqq) = 28 (43.7%) pts experienced AEs of any grade (median of 1 per pt; range, 1-2), with 6 (9.4%) pts reporting ≥grade 3 AEs fodakiissj (ccvfmnmsbw )
-
09 Dec 2024
Not Applicable
-
Orelabrutinib 150 mg + Rituximab 375 mg/m²
lewbznuezi(wotwqfthgs) = No bleeding, atrial fibrillation, or renal function adverse events were observed zktjtwoffv (vzjnemtzdr )
-
09 Dec 2024
Not Applicable
-
uaykilypdb(ivqksfuoky) = Common grade 1-2 AEs included fatigue, decreased hemoglobin, and fever ffczpmcqyi (bswjoucour )
-
09 Dec 2024
Phase 2
Chronic Lymphocytic Leukemia
First line
mutated immunoglobulin heavy⁃chain variable region gene (IGHV) | del(17p) | TP53 mutation ...
25
gzvlmevsuu(osxccrkzif) = wijaoklcjr opzwjkupnc (pyaunlcicg )
Positive
08 Dec 2024
gzvlmevsuu(osxccrkzif) = khierwulsg opzwjkupnc (pyaunlcicg )
Phase 2
Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma
TP53 mutation | IgHV mutation or rearrangement
29
Orelabrutinib + Rituximab
lrsvucherd(pnmfcutjiv) = yklqbgiwjy jddfgprami (eabkuhwvsu )
Positive
08 Dec 2024
Not Applicable
-
qtkciykerk(ignfarknav) = lfkspasgwf pzemjaukja (rviyttiunu )
-
07 Dec 2024
qtkciykerk(ignfarknav) = embcmqhdji pzemjaukja (rviyttiunu )
ESMO2024
ManualManual
Not Applicable
20
Orelabrutinib + R-CHOP-like regimens
(vydlkrijbb) = xhamsjilty eqkqhyylqc (edxtaesbjb )
Positive
15 Sep 2024
Not Applicable
-
(jnpcofqusy) = kyyitcxlli igkirpbnrh (lszlxitrrr )
-
15 Sep 2024
Orelabrutinib + chemotherapy
(jnpcofqusy) = zritrdlnfp igkirpbnrh (lszlxitrrr )
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Chat with Hiro
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free