RegulationOrphan Drug (United States), Breakthrough Therapy (China), Conditional marketing approval (China), Special Review Project (China), Priority Review (China)

Structure/Sequence

Molecular FormulaC28H37FN6O5S

InChIKeyNVWKNQGHVMMAJW-UHFFFAOYSA-N

CAS Registry1702816-75-8

Clinical Trials associated with Linperlisib

NCT07031115

/ Not yet recruitingPhase 2IIT

Linperlisib in Acquired Pure Red Cell Aplasia: a Single-arm,Cphase II Prospective Clinical Study

Pure red cell aplasia (PRCA) is a syndrome characterized by normocytic normochromic anemia, reticulocytopenia, and reduced erythroid precursors in an otherwise normocellular bone marrow. It primarily affects erythropoiesis, while granulocytic and megakaryocytic lineages typically remain unaffected. First-line therapies for PRCA include corticosteroids (CS) and cyclosporine A（CsA). Although CS demonstrates high response rates, relapse frequently occurs upon dose reduction or discontinuation. CsA achieves response rates of 65%-87%, yet exhibits a delayed onset of action, often requiring 2-3 months to achieve transfusion independence. Sirolimus constitutes a second-line option, with additional therapeutic agents including methotrexate and cyclophosphamide.
Phosphatidylinositol 3-kinases (PI3Ks) represent a family of lipid kinases. The δ and γ isoforms are predominantly expressed in leukocytes and are frequently activated in various B-cell lymphomas, serving as the primary therapeutic targets for currently approved PI3K inhibitors in hematological malignancies. PI3K also plays a critical role in modulating cells of both the adaptive and innate immune systems. Studies indicate that engagement of multiple immune receptors on leukocytes triggers PI3K activation. Consequently, isoform-selective (δ or γ) or dual δ/γ inhibitors are being investigated for autoimmune conditions such as COPD, asthma, allergies, and Sjögren's syndrome. Leniolisib, the first oral PI3Kδ inhibitor approved by the FDA for immunodeficiency, exemplifies this therapeutic strategy. Several other PI3K-targeting agents are under clinical evaluation, including Parsaclisib (Phase II trial in relapsed/refractory autoimmune hemolytic anemia) and Linperlisib (Phase I trial in relapsed/refractory AIHA).
T-lymphocyte dysfunction is a pivotal factor in PRCA pathogenesis. RNA sequencing analyses have revealed significant upregulation of genes associated with the PI3K/AKT/mTOR pathway in bone marrow CD8+ T lymphocytes of patients with acquired PRCA, suggesting that targeting this pathway may represent a novel therapeutic strategy. Linperlisib, a highly selective PI3Kδ inhibitor approved for relapsed/refractory follicular lymphoma, suppresses PI3Kδ protein expression and reduces AKT phosphorylation, thereby inducing apoptosis and inhibiting lymphocyte proliferation. In 2024, a seminal report documented rapid responses and manageable tolerability with Linperlisib in four patients with acquired PRCA.
Currently, no cohort studies have been conducted on Linperlisib for PRCA treatment. This study seeks to characterize the dosing regimen, efficacy, and safety profile of Linperlisib in relapsed/refractory pure red cell aplasia.

Start Date01 Sep 2025

Sponsor / Collaborator

Peking Union Medical College Hospital

NCT06981988

/ Not yet recruitingPhase 1/2

A Study to Explore the Dosage and Efficacy of Linperlisib in Combination With Rituximab and to Validate the Efficacy of Linperlisib in Patients With Relapsed/Refractory Indolent NHL

The study is being conducted to evaluate the reasonable dosage, efficacy and safety of Linperlisib in combination with rituximab in subjects with relapsed/refractory (R/R) indolent non-hodgkin lymphoma(NHL) in adults.

Start Date01 Jun 2025

Sponsor / Collaborator

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

NCT06793956

/ RecruitingPhase 1IIT

Open-Label, Phase Ib Study of Sintilimab and Linperlisib Combination Treatment in Patients with Relapsed or Refractory Extranodal Natural Killer/T Cell Lymphoma (NKTCL)

This is an open-label, phase Ib study evaluating the combination treatment of sintilimab and linperlisib in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (NKTCL).

Start Date21 Feb 2025

Sponsor / Collaborator

Sun Yat-Sen University

100 Clinical Results associated with Linperlisib

100 Translational Medicine associated with Linperlisib

100 Patents (Medical) associated with Linperlisib

Literatures (Medical) associated with Linperlisib

13 Jun 2025·MEDICINE

Linperlisib causing high blood sugar and hyponatremia, leading to facial nerve paralysis and muscle nerve damage: A rare case report

Article

Author: Jiang, Yu-cai ; Zhao, Cheng-fei ; Zheng, Lin-lin

Rationale::

Linperlisib is a highly selective small-molecule inhibitor of phosphatidylinositol-3-kinase delta for the treatment of relapsed/refractory follicular lymphoma.

Patient concerns::

The patient was a 64-year-old male with peripheral T-cell lymphoma and diabetes mellitus who experienced hyperglycemia, hyponatremia, facial palsy, and myalgia during linperlisib treatment.

Diagnoses::

Drug-induced high blood sugar and hyponatremia.

Interventions::

Active management of hyperglycemia during hospitalization and hyponatremia was corrected with active symptomatic treatment.

Outcomes::

During hospitalization, the patient’s hyperglycemia and hyponatremia were effectively managed through active symptomatic treatment. However, following a reduction in the linperlisib dose, the patient developed recurrent hyperglycemia, hyponatremia, and new-onset myalgia. Consequently, the patient declined further linperlisib therapy and permanently discontinued the medication.

Lessons::

Clinicians should be aware of the risk of complications such as hyperglycemia and hyponatremia in patients with lymphoma and diabetes receiving linperlisib.

01 Apr 2025·Cell Reports Medicine

KLRG1 re-defines a leukemic clone of CD8 effector T cells sensitive to PI3K inhibitor in T cell large granular lymphocytic leukemia

Article

Author: Chu, Yajing ; Zhang, Lele ; Yuan, Weiping ; Shi, Jun ; Li, Weiwang ; Tian, Linzhu ; Xu, Jing ; Shen, Yucan ; Li, Ruonan ; Liang, Qian ; Qiu, Chen ; Fang, Liwei ; Kuang, Zhexiang ; Gao, Zhen ; Yu, Xiao ; Zhao, Jingyu ; Pan, Hong ; Chang, Hong

T cell large granular lymphocytic leukemia (T-LGLL) is a clonal lymphoproliferative disorder, originated from mature effector memory CD8⁺ T cells. It is a challenge to define the leukemic T cell clones due to the lack of definite markers. Here, we decipher the heterogeneity of CD8⁺ T cells using cellular indexing of transcriptomes and epitopes by sequencing (CITE-seq) and T cell receptor (TCR) profiling in T-LGLL patients. A CD8⁺ terminal effector subset is identified, marked by reduced KLRG1 expression. Remarkably, high fidelity of leukemic clonality was specially limited in KLRG1^- large granular lymphocytes (LGLs), not seen in KLRG1⁺ LGLs in T-LGLL patients or in KLRG1^- LGLs in healthy controls. KLRG1^- leukemic LGLs show upregulated PI3K signaling with enhanced cytotoxicity and exhaustion, persisting after conventional treatment. In a pilot trial of linperlisib (a PI3Kδ inhibitor) for refractory cases, 7 of 8 participants quickly respond with satisfactory safety. This study is registered at ClinicalTrials.gov (NCT05676710).

01 Feb 2025·International Journal of Clinical Oncology

Phase Ib study of the oral PI3Kδ inhibitor linperlisib in patients with advanced solid tumors

Article

Author: Xu, Zuhong ; Feng, Yi ; Shentu, Jiangzhong ; Xu, Zusheng ; Mou, Haibo ; Yin, Yongmei ; Li, Jin ; Liu, Tianshu ; Bao, Hanying ; Xu, Nong ; Xue, Junli ; Zhang, Jun ; Huang, Jianjin

Abstract:

Background:

Patients with advanced solid tumors have a suboptimal prognosis. This study investigated the safety and feasibility of linperlisib, a selective phosphatidylinositol 3-kinase delta isoform (PI3Kδ) inhibitor, for treating patients with advanced solid tumors.

Methods:

In this phase Ib, single-arm, open-label, multi-center clinical trial, patients with histologically confirmed advanced solid tumors from eight centers in China were enrolled to receive oral linperlisib (80 mg/day). The primary endpoint was safety.

Results:

Between August 2019 and June 2022, 94 patients were enrolled in the trial and received the study treatment. The most common (≥ 20%) treatment emergent adverse events (TEAEs) of all grades irrespective of causality were increased aspartate aminotransferase (AST) (26.6%), proteinuria (26.6%), decreased appetite (25.5%), increased alanine aminotransferase (ALT) (22.3%), weight loss (21.3%), and anemia (21.3%). The most common grade ≥ 3 TEAEs were diarrhea (4.3%), increased AST (3.2%), increased ALT (3.2%), neutropenia (3.2%), anemia (3.2%), increased blood alkaline phosphatase (3.2%). The objective response rate (ORR) was 1.1% (95% confidence interval [CI] 0.0–5.8), and the disease control rate (DCR) was 37.2% (95% CI 27.5–47.8). As of the data cutoff, the median follow-up time was 4.2 months (95% CI 2.8–6.9). The median progression-free survival (PFS) was 1.85 months (95% CI 1.79–1.88). The median overall survival (OS) was not reached.

Conclusion:

Linperlisib showed an acceptable safety profile and preliminary clinical benefit in patients with a range of advanced solid tumors. Further studies of linperlisib safety and efficacy are warranted.

News (Medical) associated with Linperlisib

01 Apr 2025

·www.prnewswire.com

Yingli Pharma Announces Successful End-of-Phase 2 Meeting with FDA and Clearance of Global Multi-center Phase 3 Registration Study Design of Linperlisib for the Treatment of Relapsed and/or Refractory Peripheral T-cell Lymphoma

SAN FRANCISCO, April 1, 2025 /PRNewswire/ -- Shanghai Yingli Pharmaceutical Co., Ltd. (Yingli Pharma), a clinical stage biotechnology company developing oral small molecule drugs for cancer, metabolic, and immune diseases, announced today that it has received clearance from the US Food and Drug Administration (FDA) to initiate a global registration Phase 3 study of linperlisib versus physicians' choice of standard of care for the treatment of relapsed/refractory (R/R) peripheral T-cell lymphoma (PTCL). FDA's approval of the pivotal Phase 3 protocol follows a successful Type B End-of-Phase 2 meeting, during which Yingli Pharma discussed the overall development program and regulatory path. The Phase 3 study is planned to commence during the second quarter of 2025. Linperlisib is a potent oral small molecule inhibitor of the delta isoform of PI3 kinase (PI3Kδ) developed by Yingli Pharma. "This is a major milestone for linperlisib.", said Michael Hui, Chairman and Chief Executive Officer of Yingli Pharma, "We are very excited that linperlisib has entered the global pivotal study stage with the agreement from FDA. We will continue our mission to address patient unmet clinical needs globally and to accelerate the linperlisib clinical development program to bring more treatment options for patients with R/R PTCL." In this Phase 3 study, linperlisib will be evaluated versus physicians' choice of standard of care in R/R PTCL patients who have received one or more prior systemic therapies. The Phase 3 study will open enrollment in the U.S. and other countries. About linperlisib Linperlisib is a next-generation highly selective PI3Kδ inhibitor with a well-tolerated and differentiated safety profile as indicated from clinical trials in follicular lymphoma (FL), T-cell lymphoma and other hematologic and solid tumor studies. In November 2022, linperlisib was approved in China for the treatment of adult patients with R/R FL. Also in 2022, linperlisib received U.S. Food and Drug Administration (FDA) Orphan Drug Designations for FL, Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma and T-Cell Lymphoma. To date, over 6000 patients have been treated with linperlisib in clinical studies and post market approval with consistent and well-tolerated safety profile. Linperlisib has been studied in three clinical trials in R/R PTCL in China, U.S. and Europe, with greater than 165 R/R PTCL patients treated. Collectively, these studies have demonstrated a high objective response rate, high complete response rate, promising progression free survival, overall survival, and a very manageable safety profile through the ongoing evaluations. Overall, Chinese, U.S. and European R/R PTCL patients have exhibited similar levels of efficacy and tolerability, establishing a strong foundation for a global registration trial. About Yingli Pharma Yingli Pharma is a clinical stage biopharmaceutical company founded in 2011 and located in the National Biomedical Industry Base of Shanghai Zhangjiang InnoPark. The company is dedicated to serving unmet medical needs of patients and focuses on discovery and development of therapy for cancer, metabolic and immune diseases. Yingli Pharma is advancing a portfolio of drugs through clinical development, including panRAS, TGFβR1 oral small molecule inhibitors in oncology, and URAT1 and HIPK2 inhibitors in metabolic and immune diseases. Linperlisib, the company's first drug candidate was awarded NMPA Breakthrough Therapy status in China, making Yingli Pharma the second pharmaceutical company in China and the first in Shanghai to receive this recognition. For more information, please see: CONTACT: Wendy Xiong, MD , Email : [email protected], Phone : 669-842-3439 SOURCE Shanghai Yingli Pharmaceutical Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Orphan DrugDrug ApprovalPhase 3Breakthrough TherapyIND

11 Dec 2023

·www.prnewswire.com

Yingli Pharma presents a pivotal Phase 2 study data evaluating linperlisib in relapsed or refractory peripheral T-cell lymphoma in an oral session at the American Society of Hematology 2023 Annual Meeting

Linperlisib achieved Overall Response Rate of 48% with 30% being Complete Response and manageable safety profile in the r/r PTCL phase 2 study SHANGHAI and SAN FRANCISCO, Dec. 11, 2023 /PRNewswire/ -- Shanghai Yingli Pharmaceutical Co., Ltd. (" Yingli Pharma"), a biopharmaceutical company focused on developing oral therapies for cancer and metabolic diseases, today announced the pivotal Phase 2 clinical trial results of the investigation of linperlisib in the treatment of patients with relapsed or refractory (r/r) peripheral T-cell lymphoma (PTCL). Linperlisib is a phosphoinositide 3-kinase delta (PI3Kδ) oral inhibitor, approved in China for treatment of patients with r/r follicular lymphoma after systemic therapy. "There is a vital need for new therapies to treat highly aggressive cancers such as r/r PTCL where there are very limited treatment options." said Dr. Jun Zhu, Professor, Department of Lymphoma, Peking University Cancer Hospital & Institute, Beijing, China, who was the leading investigator for this pivotal clinical trial. "In addition to the promising efficacy and well manageable safety of linperlisib in r/r PTCL, it is noteworthy that a high proportion of the treated patients were shown to have a complete response, and responses have been seen in all the major PTCL subtypes." "Our approach is to develop novel oral agents that will allow patients to safely administer at home," said Michael Hui, CEO of Yingli Pharma, "We are delighted that the encouraging results of this study support the use of linperlisib in this hard-to-treat disease and are excited to continue developing linperlisib in more indications. The company has applied for linperlisib marketing approval in r/r PTCL in China based on these pivotal study findings." Mr. Hui added, "We look forward to the results of an ongoing open-label multi-center Phase 2 study in the U.S. and Italy in r/r PTCL and r/r CTCL." Safe and effective treatment of r/r PTCL patients The pivotal r/r PTCL Phase 2 clinical trial enrolled 98 patients (pts) from May 2021 to October 2022 at 25 clinical sites in China. The pts had a median of two lines of prior systemic therapies. Sixty-four pts (73%) had refractory disease, 59 pts (67%) had relapsed disease, and 35 pts (40%) had both relapsed and refractory diseases. All patients received linperlisib at 80 mg QD, the RP2D for the drug, with a minimum of 6 months follow-up. The linperlisib-treated patients (Full Analysis Set N = 88) evaluated by Lugano criteria, had a 48% overall response rate, including 30% complete responses and 18% partial responses, as well as a 68% disease control rate. The median Duration of Response was not reached although the 6-month DOR rate was 75%. The median PFS was 5.5 months (95% CI, 3.5, 15.6) and the median OS was 14.2 months (95%CI, 7.9, not reached). Responses were observed across PTCL subtypes. Linperlisib was well tolerated with a differentiated and manageable safety profile, specifically having very low levels of immune-mediated toxicities. In the linperlisib-treated patient safety dataset (N=98) for the pivotal study, the most common hematologic treatment related adverse events (TRAEs) of Grade≥3 were neutropenia (32%), leukocytopenia (10%), Anemia (6%), Thrombocytopenia (5%), and Lymphocytopenia (5%). The most common nonhematologic TRAEs of Grade≥3 were pneumonia (14%) and upper respiratory tract infection (5%). Immune-mediated Grade≥3 TRAEs including elevated ALT, AST, diarrhea, colitis, rash were not reported or were <5%. Nine patients (9.2%) discontinued from the study due to various adverse events. The safety results of this study were consistent with previously reported data in other linperlisib clinical studies. About linperlisib Linperlisib, a next-generation PI3K-selective oral inhibitor, received marketing approval in China in 2022 for treatment of patients with relapsed and/or refractory follicular lymphoma after two or more systemic therapies. Linperlisib also received U.S. FDA Orphan Drug Designations for follicular lymphoma, chronic lymphocytic leukemia, and T cell lymphomas. Linperlisib is under investigation in multiple additional clinical trials as a monotherapy: frontline PTCL, r/r large granular T lymphocytic leukemia, r/r autoimmune hemolytic anemia; and in combination with other agents: in second line follicular lymphoma and marginal zone lymphoma, frontline PTCL, and r/r CTCL. In the U.S. and EU, linperlisib is being developed by 280Bio, Inc (San Francisco, CA., USA), a wholly-owned subsidiary of Yingli Pharma, in a Phase 2 clinical study in r/r T Cell Lymphomas [PTCL and CTCL]. About Yingli Pharma Shanghai Yingli Pharmaceutical Co., Ltd., founded in 2011 and located in the National Biomedical Industry Base of Shanghai Zhangjiang InnoPark, is a clinical-stage biotechnology company developing oral drugs for oncology and metabolic diseases. Yingli Pharma has partnered with Jiangsu Hengrui Pharmaceuticals Co., Ltd., for Greater China commercialization of linperlisib (Intarel®) in r/r follicular lymphoma that is conditionally approved, and other heme indications. Yingli Pharma is currently developing other oral agents in clinical stage from its oncology portfolio, including YL-13027 (TGFR1 inhibitor), YL17231 (pan-RAS inhibitor), YL-15293 (KRASG12C inhibitor), as well as a rich pipeline of additional novel oral agents in oncology. For more information, please see: SOURCE Shanghai Yingli Pharmaceutical Co., Ltd.

Phase 2Clinical ResultOrphan DrugASHDrug Approval

05 Sep 2022

·www.prnewswire.com

Yingli Pharma Announces First Patient Dosed in Phase 2 Trial of Linperlisib for Peripheral T Cell Lymphoma

SAN FRANCISCO, Sept. 3, 2022 /PRNewswire/ -- Yingli Pharma (the "Company" or "Yingli"), a clinical stage biotechnology company developing oral small molecule drugs for cancers with high unmet need, announced today that the first patient has been dosed in a Phase 2 trial evaluating linperlisib, a potent inhibitor of the delta isoform of PI3 kinase (PI3Kδ) in patients with relapsed/refractory peripheral T/NK cell lymphoma (r/r PTCL). This single arm study will evaluate the safety, efficacy and pharmacokinetics of orally administered linperlisib under a strategic collaboration with The University of Texas MD Anderson Cancer Center. Additional trial sites will include medical centers in the United States and Italy. "We are pleased to commence this study of linperlisib in the United States in patients suffering from advanced PTCL," said Michael Hui, MBA, chief executive officer of Yingli. "Linperlisib is a next generation inhibitor of PI3Kδ with enhanced selectivity and potency to offer strong anti-tumor effect while minimizing potential adverse reactions. We are encouraged by the safety and preliminary efficacy data obtained in Phase 1 dose-finding studies in China and look forward to further evaluating linperlisib's potential in this Phase 2 study." "Patients living with advanced PTCL, an aggressive type of lymphoma, face limited treatment options and most do not respond or stop responding to available therapies. Linperlisib may provide a solution for these patients who need an expanded treatment armamentarium, and we're excited to continue studying the drug's potential as we start the Phase 2 study." Linperlisib, a convenient once daily oral drug, is a small molecule inhibitor of PI3Kδ, a validated target in lymphomas due to its critical role in cell proliferation and survival. This Phase 2 (NCT05274997), single arm, open-label trial will evaluate the safety, efficacy and pharmacokinetic properties of linperlisib monotherapy in adult patients with r/r PTCL who have failed at least one prior line of systemic therapy. Enrolled participants will receive linperlisib 80mg once daily orally in a 28-day cycle. The primary outcome is overall response rate to treatment. Secondary outcomes include duration of response, overall survival, progression-free survival, adverse effects and pharmacokinetics parameters. An estimated 97 patients will be enrolled in the study. About Linperlisib Linperlisib (YY-20394) is a highly selective and potent PI3Kδ inhibitor that has shown a favorable safety profile, encouraging anti-tumor activities and promising PK and pharmaceutical properties as an oral once-a-day agent in late-stage clinical development. A Phase 1 clinical trial was completed in 2020 demonstrating linperlisib to be a safe and tolerable agent, and a recommended Phase 2 dose of 80 mg QD was established. Linperlisib was awarded NMPA Breakthrough Therapy status in China, leading to a Phase 2 study in follicular lymphoma (FL) that was completed and submitted in 2021 to China marketing authority for approval. In addition, linperlisib received FDA Orphan Drug Designations for FL, CLL/SLL and T cell lymphoma. Multiple linperlisib clinical trials in FL, PTCL, other lymphomas, solid tumors, combination with gemcitabine/oxaliplatin in r/r DLBC and combination with therapeutic PD1 antibody are underway in China. Preliminary results of single agent linperlisib from a relapsed or recurrent PTCL Phase1b study were reported at ASCO 2021, indicating an overall response rate of 70% with 33% CRs for this difficult to treat and aggressive form of lymphoma. About Yingli Pharma Yingli Pharma is developing oral small molecule drugs with first-in-class or best-in-class potential for cancers with high unmet need. In addition to linperlisib, Yingli's clinical stage portfolio under development in U.S. and China also includes YL-13027, a TGFbeta Receptor 1 small molecule antagonist, currently in Phase 1, and YL-15293, a KRAS G12C inhibitor in Phase 1 studies that are part of a precision medicine program targeting oncogene drivers in cancer. Yingli is advancing several early-stage precision therapy programs leading to IND-enabling studies this year. For more information, visit http://www.yl-pharma.com

CollaborateAntibodyOrphan DrugBreakthrough TherapyFirst in Class

100 Deals associated with Linperlisib

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Recurrent Follicular Lymphoma	China	Shanghai Yingli Pharmaceutical Co., Ltd.	08 Nov 2022
Refractory Follicular Lymphoma	China	Shanghai Yingli Pharmaceutical Co., Ltd.	08 Nov 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Peripheral T-Cell Lymphoma	NDA/BLA	China	Shanghai Yingli Pharmaceutical Co., Ltd.	07 Sep 2023
Peripheral T-Cell Lymphoma	NDA/BLA	China	Jiangsu Xuantai Pharmaceutical Co., Ltd	07 Sep 2023
CD-30 positive Peripheral T-Cell Lymphoma	Phase 3	-	Shanghai Yingli Pharmaceutical Co., Ltd.	10 Sep 2024
Indolent Non-Hodgkin Lymphoma	Phase 2	-	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Jun 2025
Extranodal NK-T-Cell Lymphoma	Phase 2	United States	Shanghai Yingli Pharmaceutical Co., Ltd.	01 May 2022
B-cell lymphoma refractory	Phase 2	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Oct 2021
thymic carcinoma	Phase 2	China	Shanghai Yingli Pharmaceutical Co., Ltd.	28 Jul 2021
NK-cell lymphoma	Phase 2	China	Shanghai Yingli Pharmaceutical Co., Ltd.	12 Mar 2021
Diffuse large B-cell lymphoma recurrent	Phase 2	-	Shanghai Yingli Pharmaceutical Co., Ltd.	20 Aug 2020
B-Cell Lymphoma	Phase 2	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	-

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EHA2025 Manual	Not Applicable	Peripheral T-Cell Lymphoma	14	Linperlisib + Azacitidine	bjffxrnprx(gcnjmxetav) = othqpqnwpu sdxhrgtzgi (zorbrveswf ) View more	Positive	12 Jun 2025
PB3278 (EHA2025)	Not Applicable	Peripheral T-Cell Lymphoma	14	Linperlisib + Azacitidine	ldcdofjuhk(epcwsgytrp) = 71.4% uqjltumudq (tmtbanlbbz ) View more	Positive	14 May 2025
NCT04500561 (Pubmed \| Cancer Cell Int) Manual	Phase 1/2	Diffuse Large B-Cell Lymphoma	39	Linperlisib + Gemcitabine + Oxaliplatin	jaqtjfjxps(qcnpcnlprv) = nhwnrttvsd ipfipnoxri (dbefozorci, 37.2 - 69.9) View more	Positive	08 Feb 2025
ASH2023	Phase 2	Extranodal NK-T-Cell Lymphoma	98	Linperlisib 80 mg	jwjxpxupcm(ysayabfcdy) = wfycihjncx mizpwptonu (fachehhqsb ) View more	Positive	09 Dec 2023
ASH2023	Phase 1	B-Cell Malignant Neoplasm	43	Linperlisib	bdrdkivdks(kqzffwvfbu) = mjrsexgmyq gzmbnadwfx (ocqremnthc, 31.2 - 62.3) View more	-	09 Dec 2023
NCT04500561 (ASH2023)	Phase 1/2	Diffuse large B-cell lymphoma recurrent	39	Linperlisib + GEMOX	dmbzspfxjr(leqhuinckw) = xitzoavymh jjgptdtfjd (ckexhkohjd, 37.2 - 69.9) View more	-	09 Dec 2023
NCT04370405 (ASH2023)	Phase 2	Refractory Follicular Lymphoma	84	Linperlisib	wikzlvfvtw(epmfiggsmn) = cepuuueayq rkrpxoaolv (fifvyocqcn ) View more	-	09 Dec 2023
NCT04370405 (phase 2 trial, ICML2023)	Phase 2	Follicular Lymphoma	84	Linperlisib 80 mg	flhiwlrukg(kiuraayjde) = nivtqptffl hrltltdjwg (tfdpcirltt, 64.5 - 86.9) View more	Positive	09 Jun 2023
NCT04370405 (phase 2 trial, ICML2023)	Phase 2	Follicular Lymphoma	84	Placebo	flhiwlrukg(kiuraayjde) = loqbbsziyq hrltltdjwg (tfdpcirltt, 66.4 - 97.2) View more	Positive	09 Jun 2023
NCT04500561 (YY-20394-008, EHA2023)	Phase 2	Diffuse large B-cell lymphoma refractory \| Diffuse large B-cell lymphoma recurrent	39	Linperlisib + GEMOX	dwwsgttitr(zthmxmawwe) = ksqnkdgrqg kmrucxjnlj (zllvyizwxf, (40.0 - 97.2)) View more	-	08 Jun 2023
NCT04370405 (EHA2023)	Phase 2	Follicular Lymphoma	84	LINPERLISIB (Relapsed-only disease)	zxiazdlxpq(cvtqobfpwa) = dlfimwfqee fuxcaqzfls (hazsuhiooi )	-	08 Jun 2023
NCT04370405 (EHA2023)	Phase 2	Follicular Lymphoma	84	LINPERLISIB (Refractory disease)	zxiazdlxpq(cvtqobfpwa) = ebuhukrmii fuxcaqzfls (hazsuhiooi )	-	08 Jun 2023

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