Ireland
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Priya Life Science Compound trial record
Compound · clinical trials

Rocbrutinib clinical trials

Also listed in trial records as LP-168, NWP-775
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 11 trials in our China and USA registers that name Rocbrutinib as an intervention. Synced 9 Nov 2026
11Current trials
9Recruiting now
2Lead sponsors
2Country registers
At a glance

Rocbrutinib is named as an intervention in 11 current clinical trials in our China and USA registers. 9 are recruiting patients now. The most common phase is Phase 1. The sponsor with the most trials is Guangzhou Lupeng Pharmaceutical Company LTD (9). The most-studied condition is Diffuse Large B-Cell Lymphoma (DLBCL). The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.

How Rocbrutinib works

All drug targets →
Diseases it has been tested for in clinical trials, by furthest phase
  • B-cell chronic lymphocytic leukemiaPhase 3
  • Mantle cell lymphomaPhase 3
  • Diffuse large B-cell lymphomaPhase 2
  • Waldenstrom macroglobulinemiaPhase 1
  • Follicular lymphomaPhase 1
  • Hairy cell leukemiaPhase 1
  • Marginal zone lymphomaPhase 1
  • Non-Hodgkin lymphomaPhase 1

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL5314539, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 12875, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Rocbrutinib

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Reference identifiers for Rocbrutinib

ChEMBL
CHEMBL5314539
DrugBank
DB19445
PubChem CID
139416847
CAS number
2485861-07-0
FDA UNII
KD68L3GRW2
Wikidata
Q140641595
Wikipedia
Rocbrutinib

Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.

Trials by status

  • Recruiting982%
  • Active, closed218%

Trials by phase

  • Phase 1545%
  • Phase 2327%
  • Phase 3218%
  • Phase 1/219%
01

Clinical trials of Rocbrutinib

11 trials
StudyPhaseStatusLead sponsorRegisters
ROCKET-CLL Global Phase 3 Study: Rocbrutinib vs Pirtobrutinib in cBTKi-Pretreated R/R CLL/SLL
NCT07342478 · CLL / SLL, CLL (Chronic Lymphocytic Leukemia), CLL, Refractory
Phase 3 Recruiting Newave Pharmaceutical Inc USA
A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma
NCT07377578 · ClinicalTrials.gov ↗ · Mantle Cell Lymphoma
Phase 3 Recruiting Guangzhou Lupeng Pharmaceutical Company LTD China
A Study of Rocbrutinib in Participants With Relapse or Refractory Non-GCB Diffuse Large B-Cell Lymphoma
NCT07189065 · ClinicalTrials.gov ↗ · Diffuse Large B-Cell Lymphoma (DLBCL)
Phase 2 Recruiting Guangzhou Lupeng Pharmaceutical Company LTD China
A Study of Rocbrutinib in PRL-Positive Relapsing-Remitting Multiple Sclerosis
NCT07776743 · ClinicalTrials.gov ↗ · Relapsing-remitting Multiple Sclerosis (RRMS)
Phase 2 Recruiting Guangzhou Lupeng Pharmaceutical Company LTD China
A Study of Rocbrutinib in Combination With Lacutoclax in Patients With B-Cell Malignancies
NCT07609862 · ClinicalTrials.gov ↗ · Mantle Cell Lymphoma (MCL), Diffuse Large B-Cell Lymphoma (DLBCL), Follicular Lymphoma ( FL)
Phase 1/2 Recruiting Guangzhou Lupeng Pharmaceutical Company LTD China
Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies.
NCT04775745 · CLL/SLL, Waldenstrom Macroglobulinemia, Follicular Lymphoma
Phase 1 Recruiting Newave Pharmaceutical Inc USA
A Study of LP-168 in Participants With Relapse or Refractory B-Cell Lymphoma
NCT04993690 · ClinicalTrials.gov ↗ · B-cell Lymphoma
Phase 1 Recruiting Guangzhou Lupeng Pharmaceutical Company LTD China
A Study Evaluating the Effects of Itraconazole or Rifampin on the Pharmacokinetic Characteristics of Rocbrutinib Tablet
NCT07374224 · ClinicalTrials.gov ↗ · Clinical Pharmacology
Phase 1 Recruiting Guangzhou Lupeng Pharmaceutical Company LTD China
A Study of Rocbrutinib Combined With R-GemOx in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
NCT07570017 · ClinicalTrials.gov ↗ · DLBCL
Phase 1 Recruiting Guangzhou Lupeng Pharmaceutical Company LTD China
A Study of Rocbrutinib in Participants With Relapse or Refractory Mantle Cell Lymphoma
NCT05716087 · ClinicalTrials.gov ↗ · Mantle Cell Lymphoma (MCL)
Phase 2 Active, closed Guangzhou Lupeng Pharmaceutical Company LTD China
Phase Ib Study of Rocbrutinib in Combination With R-CHOP in Patients With Newly Diagnosed B-cell Non-Hodgkin Lymphoma
NCT06251180 · ClinicalTrials.gov ↗ · B-cell Non-Hodgkin Lymphoma
Phase 1 Active, closed Guangzhou Lupeng Pharmaceutical Company LTD China

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Rocbrutinib in the EU trials register (CTIS)

1 trial

Authorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Rocbrutinib. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.

StudyPhaseStatusSponsorCountries
A Phase 3 Open-Label, Randomized, Multicenter Study of Rocbrutinib (LP-168) vs Pirtobrutinib in Covalent BTK Inhibitor (cBTKi) Pretreated Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) Subjects
2026-525656-28-00 · CTIS ↗ · Hemic and Lymphatic Diseases
Phase 3 Authorised Newave Pharmaceutical Inc Poland, Germany, Spain + 3 more
03

Conditions studied with Rocbrutinib

18 conditions
Diffuse Large B-Cell Lymphoma (DLBCL)2Mantle Cell Lymphoma (MCL)2CLL / SLL1CLL (Chronic Lymphocytic Leukemia)1CLL, Refractory1CLL, Relapsed1Relapsing-remitting Multiple Sclerosis (RRMS)1Mantle Cell Lymphoma1B-cell Non-Hodgkin Lymphoma1Clinical Pharmacology1Follicular Lymphoma ( FL)1Waldenström Macroglobulinemia (WM)1
All 18 conditions
Condition (as registered)Trials
Diffuse Large B-Cell Lymphoma (DLBCL)2
Mantle Cell Lymphoma (MCL)2
CLL / SLL1
CLL (Chronic Lymphocytic Leukemia)1
CLL, Refractory1
CLL, Relapsed1
Relapsing-remitting Multiple Sclerosis (RRMS)1
Mantle Cell Lymphoma1
B-cell Non-Hodgkin Lymphoma1
Clinical Pharmacology1
Follicular Lymphoma ( FL)1
Waldenström Macroglobulinemia (WM)1
DLBCL1
CLL/SLL1
Waldenstrom Macroglobulinemia1
Follicular Lymphoma1
Diffuse Large B Cell Lymphoma1
B-cell Lymphoma1
04

Sponsors

lead sponsor per trial
Lead sponsorTrials
Guangzhou Lupeng Pharmaceutical Company LTD9
Newave Pharmaceutical Inc2
05

By country register

RegisterTrialsRecruiting
Clinical trials in China97
Clinical trials in USA22
EU register (CTIS)1—

A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.

06

Related compounds

07

Questions about Rocbrutinib trials

How many clinical trials are testing Rocbrutinib?

11 current trials in our China and USA registers name Rocbrutinib (also registered as LP-168) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.

Are Rocbrutinib trials recruiting patients?

Yes. 9 of the 11 trials are recruiting: 7 with sites in China and 2 with sites in USA. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Rocbrutinib clinical trials?

Guangzhou Lupeng Pharmaceutical Company LTD (9) and Newave Pharmaceutical Inc (2). The number in brackets is how many trials each organisation leads.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Rocbrutinib works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Rocbrutinib works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Rocbrutinib (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.