Delving into the Latest Updates on Gemcitabine Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Gemcitabine hydrochloride (JAN/USP), Gemcitabine Hydrochloride for jnjection, Gemcitabine Hydrochlride

+ [15]

Target

DNA x RNRs

Action

inhibitors

Mechanism

DNA inhibitors(DNA inhibitors), RNR inhibitors(Ribonucleotide reductase inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesDigestive System Disorders+ [10]

Active Indication

Metastatic breast cancerBladder CancerLocally Advanced Lung Non-Small Cell Carcinoma+ [77]

Inactive Indication

Acinar Cell CarcinomaAcute Myeloid LeukemiaAdvanced Bile Duct Carcinoma+ [96]

Originator Organization

Eli Lilly & Co.

Active Organization

Eli Lilly & Co.

NACS, Inc.Janssen Research & Development LLC

+ [13]

Inactive Organization

AndersonBrecon, Inc.

Pfizer Inc.

GSK Plc

+ [17]

Drug Highest PhaseApproved

First Approval Date

United States (15 May 1996),

Breast CancerMetastatic breast cancerNon-Small Cell Lung Cancer+ [2]

RegulationOrphan Drug (United States), Breakthrough Therapy (United States), Orphan Drug (Japan)

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Structure/Sequence

Molecular FormulaC9H12ClF2N3O4

InChIKeyOKKDEIYWILRZIA-OSZBKLCCSA-N

CAS Registry122111-03-9

Radiation therapy improves cancer cure rates by killing cancer cells but it also contributes to long-term side effects in cancer survivors by unintentionally damaging normal organs such as the intestine. This research will what side effects patients with cancer experience, if high dose vitamin C helps reduce these side effects, and if high dose vitamin C increases the survival of patients with pancreatic cancer. We will meet with patients during the study to better understand their experience during their cancer treatment. In the long term, our research could provide a new way help cancer survivors avoid many permanent side effects of cancer treatments.

Start Date31 Dec 2025

Sponsor / Collaborator

The Holden Comprehensive Cancer Center

NCT06498648

/ SuspendedPhase 1/2IIT

Phase I/II Study to Evaluate the Feasibility and Efficacy of Sequential Abemaciclib and Gemcitabine Treatment in Patients With Retinoblastoma (Rb)+ Sarcomas

This phase 1/2 trial tests the side effects and best dose of abemaciclib when added to gemcitabine and compares the effectiveness of that treatment to the usual treatment of gemcitabine with docetaxel for the treatment of patients with soft tissue sarcoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic) (phase 1) or patients with leiomyosarcoma or dedifferentiated liposarcoma (phase 2). Abemaciclib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Giving abemaciclib with gemcitabine may be safe and effective when compared to treatment with gemcitabine and docetaxel for patients with advanced or metastatic soft tissue sarcoma or leiomyosarcoma or dedifferentiated liposarcoma.

Start Date14 Oct 2025

Sponsor / Collaborator

National Cancer Institute

NCT06858735

/ Not yet recruitingPhase 2

HYPERION CCA: a Phase 2 Trial of Systemic Therapy With or Without Liver-directed Radiation Therapy for Patients With Advanced Intrahepatic Cholangiocarcinoma

This study will compare outcomes for M1 iCCA patients treated with and without L-RT by reviewing iCCA patients found to have M1 disease at initial diagnosis at a single institution between 2010 and 2021 who received L-RT.

Start Date01 Aug 2025

Sponsor / Collaborator

AstraZeneca PLC

[+1]

100 Clinical Results associated with Gemcitabine Hydrochloride

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100 Translational Medicine associated with Gemcitabine Hydrochloride

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100 Patents (Medical) associated with Gemcitabine Hydrochloride

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18,783

Literatures (Medical) associated with Gemcitabine Hydrochloride

01 Jul 2025·BIOMATERIALS

High-density lipoprotein-based nanoplatform reprograms tumor microenvironment and enhances chemotherapy against pancreatic ductal adenocarcinoma

Article

Author: Chen, Jun ; Zhou, Songlei ; Xie, Xiaoying ; Yu, Minghua ; Huang, Yukun ; Chen, Yu ; Chen, Liang ; Xie, Jing

Pancreatic ductal adenocarcinoma (PDAC) is highly aggressive, with limited success in traditional therapies due to the fibrotic, immunosuppressive, pro-metastatic tumor microenvironment (TME), which collectively impede the drug accumulation and accelerate the tumor progression. In this work, we developed a PDAC-customized nutrient-mimicking reconstituted high-density lipoprotein (rHDL) capable of efficiently co-encapsulate versatile TME regulating cannabidiol and cytotoxic gemcitabine to simultaneously reprogram TME while suppressing PDAC progression. Specifically, a small-sized, nutrient-like rHDL was constructed to realize deep PDAC parenchyma penetration and efficient intra-tumoral uptake. Next, natural herbal compound cannabidiol was screened and incorporated into rHDL to regulate TME via attenuating fibrosis, reliving immunosuppression and mitigating metastatic tendency. At last, gemcitabine, the PDAC gold standard first-line therapy was co-delivered by the PDAC-customized rHDL to overcome drug resistance and amplify its PDAC suppression. Our findings demonstrate the feasibility of an integrated multi-stage TME regulation strategy for improved PDAC therapy, and might represent a modality in promoting chemotherapy against PDAC.

05 Jun 2025·JOURNAL OF APPLIED POLYMER SCIENCE

Synthesis and Characterization of Polymer‐Drug Conjugates by Strain‐Promoted Azide‐Alkyne Cycloaddition‐Mediated Polymerization

Author: Adesina, Simeon K. ; Gbadegesin, Omotola D.

ABSTRACT:

Polymer‐drug conjugates (PDCs) modify the biodistribution of small‐molecule anticancer agents to prevent undesired off‐target adverse effects. Here, we report the preparation of two PDCs by strain‐promoted [3 + 2] azide‐alkyne cycloaddition‐mediated step‐growth polymerization. This method does not require the use of a catalyst or high temperatures, and it allows the rapid synthesis of high molecular‐weight PDCs containing gemcitabine (Mw ~ 40.18 kDa) and doxorubicin (Mw ~ 1800 kDa) with narrow molecular weight distribution and high drug loading (29.2 wt% gemcitabine and 10.3wt% doxorubicin). α‐ω‐bis‐azide‐terminated bifunctional gemcitabine‐coupled and doxorubicin‐coupled monomers, with drug linkage via Gly‐Phe‐Leu‐Gly (GFLG), a cathepsin B‐sensitive peptide linker, were separately synthesized and polymerized using a dibenzoazacyclooctyne bifunctional polyethylene glycol monomer. Preliminary in vitro evaluations of the PDCs showed cathepsin B‐catalyzed drug release at pH 5.0. The applied method for the syntheses of the PDCs enables the selective delivery of potent anticancer agents.

24 May 2025·Journal of biomolecular structure & dynamics

Integration analysis of PLAUR as a sunitinib resistance and macrophage related biomarker in ccRCC, an in silicon and experimental study

Article

Author: Gan, Sishun ; Li, Lin ; Jiang, Aimin ; Chu, Jian ; Yang, Qiwei ; Cao, Jianwei ; Ye, Fangdie ; Tian, Yijun

Sunitinib remains the preferred systemic treatment option for specific patients with advanced RCC who are ineligible for immune therapy. However, it's essential to recognize that Sunitinib fails to elicit a favourable response in all patients. Moreover, most patients eventually develop resistance to Sunitinib. Therefore, identifying new targets associated with Sunitinib resistance is crucial. Utilizing multiple datasets from public cohorts, we conducted an exhaustive analysis and identified a total of 8 microRNAs and 112 mRNAs displaying significant expression differences between Sunitinib responsive and resistant groups. A particular set of six genes, specifically NIPSNAP1, STK40, SDC4, NEU1, TBC1D9, and PLAUR, were identified as highly significant via WGCNA. To delve deeper into the resistance mechanisms, we performed additional investigations using cell, molecular, and flow cytometry tests. These studies confirmed PLAUR's pivotal role in fostering Sunitinib resistance, both in vitro and in vivo. Our findings suggest that PLAUR could be a promising therapeutic target across various cancer types. In conclusion, this investigation not only uncovers vital genes and microRNAs associated with Sunitinib resistance in RCC but also introduces PLAUR as a prospective therapeutic target for diverse cancers. The outcomes contribute to advancing personalized healthcare and developing superior therapeutic strategies.

693

News (Medical) associated with Gemcitabine Hydrochloride

17 hours ago

·www.prnewswire.com

Akeso Announces FDA Approval for Penpulimab-kcqx in Two BLA Indications for Comprehensive Treatment of Advanced Nasopharyngeal Carcinoma

HONG KONG, April 24, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is excited to announce that the U.S. Food and Drug Administration (FDA) has approved its differentiated PD-1 monoclonal antibody, penpulimab-kcqx, in combination with cisplatin or carboplatin and gemcitabine for the first-line treatment of adult recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). FDA also approved penpulimab-kcqx as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and with least one other prior line of therapy. Penpulimab-kcqx was developed independently by Akeso, with further development and commercialization managed through a joint venture with Chia Tai-Tianqing Pharmaceutical Group. This milestone marks penpulimab-kcqx as Akeso's first internally developed innovative biologic to receive FDA approval. The approval underscores the robust clinical research behind penpulimab-kcqx and marks Akeso's successful entry into the United States regulatory system for the first time. This achievement highlights the company's innovative drug development capabilities and its commitment to adhering to the highest international standards in pharmaceutical quality management. The FDA's approval of penpulimab-kcqx validates Akeso's international drug development strategy and expansion capabilities. This approval lays a strong foundation for Akeso's continued clinical development efforts in the global therapeutics markets. Penpulimab-kcqx has been approved in China for two indications: 1. first-line treatment of advanced NPC, and 2. second or later line treatment of advanced NPC. The recent FDA approval of penpulimab-kcqx offers a new, immunotherapy option for advanced NPC patients in the US. The FDA approval is based on the international Phase III clinical trial AK105-304 and the pivotal AK105-202 study, which supported the two Biologics License Application (BLA) for penpulimab-kcqx. These studies demonstrated the drug's clinical benefits and favorable safety profile across two stages of treatment for metastatic NPC. AK105-304 is a randomized, double-blind, international Phase III trial that enrolled NPC patients of diverse ethnicities. The data will be presented at the 2025 American Association for Cancer Research (AACR) Annual Meeting. Previously, the FDA granted penpulimab-kcqx Breakthrough Therapy Designation (BTD), Orphan Drug Designation (ODD), and Fast Track Designation (FTD) for NPC treatment, highlighting the critical unmet need for this therapy. According to the WHO 2020 Global Cancer Statistics, over 133,000 new NPC cases are diagnosed annually worldwide, with more than 70% of the patients presented with locally advanced disease. Recurrent or metastatic NPC has a poor prognosis and limited survival. Penpulimab-kcqx's FDA approval will expand the number of NPC patients that can benefit from its treatment. Prof. Chaosu Hu, Principal Investigator of penpulimab-kcqx from Fudan University Shanghai Cancer Center, commented: "This milestone enhances international treatment guidelines for advanced NPC and extends the benefits of China's innovations to global patients, ultimately reshaping the treatment landscape for metastatic NPC worldwide." Prof. Xiaozhong Chen, Investigator of penpulimab-kcqx from Zhejiang Cancer Hospital, added: "The FDA approval of penpulimab-kcqx confirms its high efficacy and low toxicity, positioning China's innovative drug development in alignment with international standards." Dr. Yu Xia, Founder, Chairwoman, President & CEO of Akeso, expressed: "We are very excited by the approval of penpulimab-kcqx's approval in the US FDA for first line and later line NPC. Beyond reaching our first international regulatory milestone, this approval also provides an important immunotherapy treatment option for patients with NPC in the United States. The FDA approval of penpulimab-kcqx not only highlights the quality of our innovation but also underscores Akeso's focus on delivering treatments for difficult to treat cancers for patients around the world. We are deeply grateful to all the researchers, participants, and patients who have contributed to this success. Akeso will continue to advance first and best in class therapies, including bispecific antibodies and CD47 inhibitors, challenge global standards of care and unlocking the full potential of our pipeline for cancer patients everywhere." Forward-Looking Statement of Akeso, Inc. This announcement by Akeso, Inc. ( 9926. HK) contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. There can be no assurance that penpulimab-kcqx or other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. Please see Prescribing Information for penpulimab-kcqx at when it is posted. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 24 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available, and 4 new drugs with 4 new indications are under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. For more information, please visit and follow us on Linkedin. SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical ResultDrug ApprovalFast TrackOrphan Drug

24 Apr 2025

·www.fda.gov

FDA approves penpulimab-kcqx for non-keratinizing nasopharyngeal carcinoma

On April 23, 2025, the Food and Drug Administration approved penpulimab-kcqx (Akeso Biopharma Co., Ltd.) with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). FDA also approved penpulimab-kcqx as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.Full prescribing information for penpulimab-kcqx will be posted on Drugs@FDA.Efficacy and SafetyEfficacy of penpulimab-kcqx with cisplatin or carboplatin and gemcitabine was evaluated in Study AK105-304 (NCT04974398), a randomized, double-blind, multi-center trial in 291 patients with recurrent or metastatic NPC who had not received previous systemic chemotherapy for recurrent or metastatic disease. Patients were randomized (1:1) to receive either penpulimab-kcqx with cisplatin or carboplatin and gemcitabine, followed by penpulimab-kcqx, or placebo with cisplatin or carboplatin and gemcitabine, followed by placebo. Chemotherapy regimens are described in the full prescribing information.The primary efficacy outcome measure was progression-free survival (PFS), as assessed by a Blinded Independent Review Committee according to RECIST v1.1. Overall survival (OS) was a key secondary endpoint. Median PFS was 9.6 months (95% CI: 7.1, 12.5) in the penpulimab-kcqx arm and 7.0 months (95% CI: 6.9, 7.3) in the placebo arm (hazard ratio [HR] 0.45 [95% CI: 0.33, 0.62], two-sided p-value <0.0001), with 31% and 11% of patients alive and progression-free after 12 months of follow-up in the penpulimab-kcqx and placebo arms, respectively. While OS results were immature, with 70% of pre-specified deaths for the final analysis reported, no detrimental trend was observed.Efficacy of single-agent penpulimab-kcqx was evaluated in Study AK105-202 (NCT03866967), an open-label, multicenter, single-arm trial conducted in a single country. The trial included a total of 125 patients with unresectable or metastatic non-keratinizing NPC who had disease progression after platinum-based chemotherapy and at least one other line of therapy. Patients received penpulimab-kcqx until disease progression or unacceptable toxicity, for a maximum of 24 months.The major efficacy outcome measures were objective response rate (ORR) and duration of response (DOR) according to RECIST v1.1 as assessed by an Independent Radiology Review Committee. The ORR was 28% (95% CI: 20, 37) and median DOR was not reached (95% CI: 9.2, not estimable).Immune-mediated adverse reactions occurred with penpulimab-kcqx including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis with renal dysfunction, and skin adverse reactions. The most common adverse reactions (≥20%) for penpulimab-kcqx with cisplatin or carboplatin and gemcitabine were nausea, vomiting, hypothyroidism, constipation, decreased appetite, decreased weight, cough, COVID-19 infection, fatigue, rash, and pyrexia. The most common adverse reactions (≥20%) for single-agent penpulimab-kcqx were hypothyroidism and musculoskeletal pain. Fatal adverse reactions occurred in 1% of patients, including a case each of pneumonitis, septic shock, colitis, and hepatitis.The recommended penpulimab-kcqx dose with cisplatin or carboplatin and gemcitabine is 200 mg every three weeks until disease progression or unacceptable toxicity, for a maximum of 24 months. The recommended single-agent penpulimab-kcqx dose for previously treated NPC is 200 mg every two weeks until disease progression or unacceptable toxicity, for a maximum of 24 months.Expedited ProgramsThis review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.This application was granted fast track designation, breakthrough designation, and orphan drug designation. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.Follow the Oncology Center of Excellence on X: @FDAOncology.

Clinical ResultFast TrackOrphan DrugDrug Approval

23 Apr 2025

·www.globenewswire.com

Compass Therapeutics Announces First Patient Dosed in an Investigator Sponsored Trial of Tovecimig in the First-Line Setting for Patients with Biliary Tract Cancer

April 21, 2025 -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics, announced the first patient has been dosed in an Investigator Sponsored Trial (IST) to evaluate tovecimig (CTX-009, a DLL4 x VEGF-A bispecific antibody) for the first time in the front-line setting for patients with biliary tract cancer (BTC). The IST is being conducted at The University of Texas MD Anderson Cancer Center. “This first-line study of tovecimig in patients with BTC represents a significant step forward and we are deeply grateful to the dedicated team at MD Anderson for their leadership in conducting this trial,” said Thomas Schuetz, MD, PhD, CEO of Compass and Vice Chairman of the Board of Directors. “The IST complements our ongoing second-line Phase 2/3 study of tovecimig in patients with biliary tract cancer; importantly, we recently announced that tovecimig met the primary endpoint in our Phase 2/3 Study. We expect to report results of the secondary endpoints in the Phase 2/3 Study, including progression-free survival (PFS) and overall survival (OS), in the fourth quarter of this year.” In the MD Anderson-led, open-label trial, tovecimig is being added to a standard first-line regimen of gemcitabine, cisplatin, and durvalumab in an estimated 50 patients with unresectable or metastatic BTC. The study will have a standard safety run-in phase in 12 patients followed by an expansion phase in which 38 additional patients will be treated. The primary objectives in the study are to assess 6-month progression-free survival, to assess the tolerability and safety of this combination, and to determine the maximum tolerated dose of tovecimig in this combination. Secondary objectives include overall response rate (ORR), duration of response (DoR), progression-free survival (PFS) and overall survival (OS). Tovecimig is a bispecific antibody that simultaneously blocks Delta-like ligand 4 (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways, which are critical to angiogenesis and tumor vascularization. Preclinical and early clinical data of tovecimig suggest that blockade of both pathways provides robust anti-tumor activity across several solid tumors, including colorectal, gastric, cholangiocarcinoma, pancreatic and non-small cell lung cancer. Partial responses to tovecimig as a monotherapy have been observed in heavily pre-treated patients with cancer who were resistant to approved anti-VEGF therapies. COMPANION-002, a Phase 2/3 trial of tovecimig plus paclitaxel versus paclitaxel monotherapy in patients with previously treated, unresectable advanced metastatic or recurrent biliary tract cancers (BTC) is ongoing (clinical trial information: NCT05506943). Compass Therapeutics, Inc. is a clinical-stage oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. Compass’s scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth. The company pipeline of novel product candidates is designed to target multiple critical biological pathways required for an effective anti-tumor response. These include modulation of the microvasculature via angiogenesis-targeted agents, induction of a potent immune response via activators on effector cells in the tumor microenvironment, and alleviation of immunosuppressive mechanisms used by tumors to evade immune surveillance. Compass plans to advance its product candidates through clinical development as both standalone therapies and in combination with proprietary pipeline antibodies based on supportive clinical and nonclinical data. The company was founded in 2014 and is headquartered in Boston, Massachusetts. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultImmunotherapyClinical Study

100 Deals associated with Gemcitabine Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
D01155	Gemcitabine Hydrochloride	L01BC05	DB00441

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Bladder Cancer	Australia	Sandoz Pty Ltd.	02 Dec 2008
Locally Advanced Lung Non-Small Cell Carcinoma	Australia	Sandoz Pty Ltd.	02 Dec 2008
Locally Advanced Pancreatic Adenocarcinoma	Australia	Sandoz Pty Ltd.	02 Dec 2008
metastatic non-small cell lung cancer	Australia	Sandoz Pty Ltd.	02 Dec 2008
Pancreatic adenocarcinoma metastatic	Australia	Sandoz Pty Ltd.	02 Dec 2008
Recurrent ovarian cancer	Australia	Sandoz Pty Ltd.	02 Dec 2008
Transitional Cell Carcinoma	Japan	Eli Lilly & Co.	25 Nov 2008
Biliary Tract Neoplasms	Japan	Eli Lilly & Co.	31 Aug 2001
Lymphoma	Japan	Eli Lilly & Co.	31 Aug 2001
Ovarian Cancer	Japan	Eli Lilly & Co.	31 Aug 2001
Breast Cancer	United States	Eli Lilly & Co.	15 May 1996
Metastatic breast cancer	United States	Eli Lilly & Co.	15 May 1996
Non-Small Cell Lung Cancer	United States	Eli Lilly & Co.	15 May 1996
Pancreatic adenocarcinoma	United States	Eli Lilly & Co.	15 May 1996
Pancreatic Cancer	United States	Eli Lilly & Co.	15 May 1996

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-Muscle Invasive Bladder Neoplasms	NDA/BLA	United States	Johnson & Johnson (China) Investment Ltd.	15 Jan 2025
Recurrent Bladder Cancer	Phase 3	United States	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	China	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Japan	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Argentina	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Belgium	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Brazil	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	France	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Germany	Janssen Research & Development LLC	09 Apr 2024
Recurrent Bladder Cancer	Phase 3	Italy	Janssen Research & Development LLC	09 Apr 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04480372 (SAKK 17/18 ORIGIN, ESMO_ELCC2025)	Phase 2	Malignant Pleural Mesothelioma	30	Gemcitabine + Atezolizumab	vakwujqmsr(ncmpdyulcm) = uyndmwuuzd nzdpyutyud (hfpcqipxfi, 5.9%, 3.8% - 30.7%) View more	Positive	26 Mar 2025
Phase II study on maintenance gemcitabine (ESMO_ELCC2025)	Phase 2	Malignant Pleural Mesothelioma Maintenance complete blood count with leukocyte differential \| lactate dehydrogenase (LDH) \| erythrocyte sedimentation rate (ESR) ... View more	64	Gemcitabine maintenance	avfqswnlrj(vdwlnhuhpk) = dhmzgcpfxu tpbbdhlepl (yrmjqggcuv, 2.7 - 369.0) View more	-	26 Mar 2025
				gemcitabine (Best supportive care)	avfqswnlrj(vdwlnhuhpk) = ftfqpdrmrz tpbbdhlepl (yrmjqggcuv, 0.8 - 25.0) View more
NCT02506959 (CTgov)	Phase 2	Recurrent Multiple Myeloma \| Relapse multiple myeloma \| Refractory Multiple Myeloma ... View more	83	Peripheral Blood Stem Cell Transplantation+Panobinostat+Busulfan+Melphalan+Gemcitabine Hydrochloride (Cohort 1_1st Auto TP Conditioned With Panobinostat and Gem/Bu/Mel)	kntwmrygeo = rcuahvudlc frkgndbzes (dgfppxdnjx, skgoafflpo - tiqhjelvzi) View more	-	18 Mar 2025
				Peripheral Blood Stem Cell Transplantation+Panobinostat+Busulfan+Melphalan+Gemcitabine Hydrochloride (Cohort 2_2nd Auto TP Conditioned With Panobinostat and Gem/Bu/Mel)	kntwmrygeo = yubsewhzvg frkgndbzes (dgfppxdnjx, xldrgnbuva - smihihypbu) View more
NCT03137771 (NRG-LU002, CTgov)	Phase 2	metastatic non-small cell lung cancer \| Recurrent Non-Small Cell Lung Cancer	218	Erlotinib Hydrochloride+Gemcitabine+Docetaxel+pembrolizumab+Pemetrexed Disodium (Arm 1 (Systemic Maintenance Chemotherapy))	uuqmublblo(ckvmegpeiu) = ddmbqqvlwp wzjydxjsrk (lxytgwppov, tnkcwnqymr - cmzplyhxmo) View more	-	11 Mar 2025
				Stereotactic Body Radiation Therapy (SBRT)+Erlotinib Hydrochloride+Gemcitabine+Docetaxel+pembrolizumab+Pemetrexed Disodium (Arm 2 (LCT + Systemic Maintenance Chemotherapy))	uuqmublblo(ckvmegpeiu) = wbbtciplwb wzjydxjsrk (lxytgwppov, mltcqlzgaj - heuoixpxvy) View more
NCT03317158 (HCRN GU16-243: ADAPT-BLADDER Cohort 4, ASCO_GU2025) Manual	Phase 1/2	Non-Muscle Invasive Bladder Neoplasms	40	Durvalumab + gemcitabine + docetaxel	fxmstyaoua(zsgcqofpto) = vihfpxtuyw ssaqydxiwm (mwrlpkvjyt ) View more	Positive	13 Feb 2025
NCT02705508 (Pubmed \| Hematology) Manual	Phase 2	Extranodal NK-T-Cell Lymphoma First line	34	PEG (pegaspargase, etoposide, gemcitabine)	bazdynrkjo(hlvksqtbsd) = nxucdqwmdu itmywwsigo (vgbpifvsxp ) View more	Positive	31 Dec 2024
ESMO_IO2024	Not Applicable	Advanced Bile Duct Carcinoma First line CEA \| albumin \| GGT ... View more	319	gemcitabine (Low Risk Group)	rfilkpmbsk(puiqvbcekq) = oqpurjtgip rwvulbuonr (nfkzmbnxto ) View more	Positive	12 Dec 2024
				gemcitabine (Intermediate Risk Group)	rfilkpmbsk(puiqvbcekq) = habeyrtvwb rwvulbuonr (nfkzmbnxto ) View more
ESMO_ASIA2024	Not Applicable	Biliary Tract Neoplasms Adjuvant	302	Gemcitabine plus Capecitabine (GEMCAP)	upxsknnhbp(girqasfmtx) = zuxwqiiqbe vaenntjcmv (drqdqimcfn )	Positive	07 Dec 2024
				Capecitabine (CAP)	upxsknnhbp(girqasfmtx) = epnrcznmyt vaenntjcmv (drqdqimcfn )
ESMO_ASIA2024	Not Applicable	Advanced biliary tract cancer First line CEA \| albumin \| GGT ... View more	319	gemcitabine (Low Risk Group)	cgjypznecy(cdrdhdlolp) = jvbduveszr aoaqechvyb (zarqgfeuep ) View more	Positive	07 Dec 2024
				gemcitabine (Intermediate Risk Group)	cgjypznecy(cdrdhdlolp) = pxvfocqpec aoaqechvyb (zarqgfeuep ) View more
NCT02312245 (CTgov)	Phase 2	Platinum-Resistant Fallopian Tube Carcinoma \| Recurrent ovarian cancer \| Recurrent Primary Peritoneal Carcinoma	13	Paclitaxel+Bevacizumab (Arm A (Avatar-directed Paclitaxel))	hjmxbdvzhw = uvzlhycner hzpkvoxzxj (rlouaieppb, xeqccrqxvs - ergwrfwgte) View more	-	05 Dec 2024
				Gemcitabine Hydrochloride (Arm B (Avatar-directed Gemcitabine Hydrochloride))	hjmxbdvzhw = jmxsybjlei hzpkvoxzxj (rlouaieppb, nhqtzvwvhr - kcotsnqaig) View more