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

+ [21]

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

Non-Muscle Invasive Bladder NeoplasmsMetastatic breast cancerLocally Advanced Lung Non-Small Cell Carcinoma+ [79]

Inactive Indication

Acinar Cell CarcinomaAcute Myeloid Leukemiaadenocarcinoma of biliary tract+ [124]

Originator Organization

Eli Lilly & Co.

Active Organization

Eli Lilly & Co.Janssen Research & Development LLCInnoPharmax, Inc.

+ [17]

Inactive Organization

Novartis AG

GSK Plc

Clovis Oncology, Inc.

+ [19]

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (15 May 1996),

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

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

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Structure/Sequence

Molecular FormulaC9H12ClF2N3O4

InChIKeyOKKDEIYWILRZIA-OSZBKLCCSA-N

CAS Registry122111-03-9

A Phase 1b/2a, Double-blind, Placebo-controlled, Three Arm, Randomized Study Evaluating a Single Intravenous Push Followed by a Continuous Infusion of Certepetide Over 4 Hours When Added to Standard of Care (SoC) Versus Two Intravenous Pushes of Certepetide When Added to SoC, Versus SoC Alone in Subjects With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (FORTIFIDE)

The goal of this clinical trial is to test a new drug plus standard treatment compared with standard treatment alone in people with metastatic pancreatic ductal adenocarcinoma.
The main questions it aims to answer are:
* is the new drug plus standard treatment safe and tolerable
* is the new drug plus standard treatment more effective than standard treatment
Participants will:
* Visit the clinic three times every 28 days for treatment and tests
* Have CT or MRI scans every 8 weeks while on treatment

Start Date01 Jan 2030

Sponsor / Collaborator

Lisata Therapeutics, Inc.

NCT07365306

/ Not yet recruitingPhase 2IIT

A Phase 2 Study of Epcoritamab-R-GemOx With Consolidative ASCT and Additional Epcoritamab in Relapsed/Refractory Transplant-Eligible DLBCL

This phase II trial tests how well epcoritamab in combination with rituximab, gemcitabine and oxaliplatin (R-GemOx) works as treatment given after the cancer has not responded to other treatments (salvage therapy) before autologous stem cell transplant in treating patients with diffuse large B-cell lymphoma (DLBCL) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Epcoritamab is a so-called bispecific antibody, a molecule that can bind simultaneously to two different receptors (proteins present on the cell surface). Epcoritamab binds to a receptor called CD3 with one part of the antibody and to a receptor called CD20 with another part of the antibody. CD3 is expressed on T cells, which are important cells of the immune system that help the body fight cancers and infections. CD20 is expressed on the surface of DLBCL cells. By simultaneous binding to CD3 and CD20, epcoritamab brings T cells and DLBCL cells close together and activates the T cells to kill the lymphoma cells. Rituximab is a so-called monoclonal antibody, a molecule that binds to a single receptor. Like epcoritamab, rituximab binds to CD20. After binding to CD20, rituximab activates the immune system to kill the lymphoma cell through several different mechanisms. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill cancer cells. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill cancer cells. Giving epcoritamab-R-GemOx as therapy before an autologous stem cell transplant may help kill cancer cells in the body and help make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow.

Start Date30 Dec 2026

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT07275216

/ Not yet recruitingPhase 2IIT

Phase 2 Study of Pembrolizumab With Chemotherapy in Frail Patients With Newly Diagnosed Classical Hodgkin Lymphoma

This phase II trial tests how well pembrolizumab in addition to chemotherapy (gemcitabine, brentuximab vedotin, and dacarbazine) works in treating frail patients with newly diagnosed Hodgkin lymphoma who aren't candidates for standard anthracycline-based treatment. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. Dacarbazine is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells and slow down or stop cancer growth. Pembrolizumab in combination chemotherapy may be a safe and effective alternative treatment option for frail patients with Hodgkin lymphoma who can't receive standard anthracycline-based treatment.

Start Date01 Jul 2026

Sponsor / Collaborator

City of Hope National Medical Center

[+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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12,577

Literatures (Medical) associated with Gemcitabine Hydrochloride

01 Jan 2026·MOLECULAR BIOTECHNOLOGY

Exploring the Effects of Opioid-Related Drugs on the Clinical Outcome of Prostate Cancer Patients Via Integrated Bioinformatics Analysis

Article

Author: Zhang, Yunxuan ; Cao, Qi ; Miao, Qi ; Liu, Yuenan ; Zhang, Xiaoping ; Chen, Kailei

Opioids are the primary regimens for perioperative analgesia with controversial effects on oncological survival. The underlying mechanism remains unexplored. This study developed survival-related gene co-expression networks based on RNA-seq and clinical characteristics from TCGA cohort. Two survival-related networks were identified, and drug-induced transcriptional profiles were predicted. Immune cell infiltration algorithm, least absolute shrinkage and selection operator (LASSO) regression, and cox proportional models were executed to explore the correlation between opioid-related drugs and prostate cancer patient prognosis. The opioid receptor agonists, represented by tramadol, were evidenced for anti-survival effects on prostate cancer by facilitating the DNA replication and cell cycle, and immune cell infiltration. Conversely, opioid receptor antagonists showed pro-survival effects. A novel prognostic model containing CNIH2, MCCC1, and Gleason scores was established and validated in two independent cohorts. This study revealed opioids' effect on prostate cancer progression, and provided a novel model to predict these regulations in clinical outcomes.

01 Jan 2026·Gan to kagaku ryoho. Cancer & chemotherapy

[Evolving Pharmacotherapy for Bladder Cancer-From Non-Muscle-Invasive to Metastatic Disease-Development of Novel Therapies for BCG-Unresponsive NMIBC].

Article

Author: Inoue, Keiji ; Shigehisa, Ryu ; Fukata, Satoshi

Bladder cancer is a common malignancy in the elderly, with approximately 75% of cases diagnosed as non-muscle-invasive bladder cancer(NMIBC).Although transurethral resection of bladder tumor(TURBT)is the standard initial treatment, recurrence rates remain high, and intravesical Bacillus Calmette-Guérin(BCG)instillation has long been used as an adjuvant therapy.However, about 30% of patients develop BCG-unresponsive disease despite adequate BCG administration.Radical cystectomy is recommended in such cases, but its invasiveness and impact on quality of life(QOL)often make it impractical in real-world settings.Thus, the development of novel bladder-preserving treatments is urgently needed.In recent years, diverse approaches including immune checkpoint inhibitors(ICI), gene therapy, drug delivery systems(DDS), and oncolytic virus-based therapies have been actively investigated, with numerous clinical trials ongoing worldwide.Importantly, pembrolizumab, nadofaragene firadenovec, and N-803 in combination with BCG have received FDA approval, representing major advances in the management of BCG-unresponsive NMIBC.In addition, promising agents such as TAR-200, cretostimogene grenadenorepvec, and detalimogene voraplasmid are under clinical evaluation.These advances indicate the potential for novel strategies that enable bladder preservation while achieving tumor control.Future challenges include validation of long-term outcomes, establishment of evidence through randomized controlled trials, and regulatory approval and reimbursement in Japan.Expansion of therapeutic options is expected to improve both prognosis and QOL in this high-risk population.

01 Dec 2025·ADVANCED MATERIALS

Rational Design of Metal–Organic Frameworks for Pancreatic Cancer Therapy: from Machine Learning Screening to In Vivo Efficacy

Article

Author: Jon Ostolaza-Paraiso ; Dhruv Menon ; João Conde ; Sergio Mercado ; Jhenifer Oliveira ; Xu Chen ; Bárbara B. Mendes ; David Fairen-Jimenez ; João Conniot ; Francesca Melle

Abstract:

Despite improvements in cancer survival rates, metastatic and surgery‐resistant cancers, such as pancreatic cancer, remain challenging, with poor prognoses and limited treatment options. Enhancing drug bioavailability in tumors, while minimizing off‐target effects, is crucial. Metal–organic frameworks (MOFs) have emerged as promising drug delivery vehicles owing to their high loading capacity, biocompatibility, and functional tunability. However, the vast chemical diversity of MOFs complicates the rational design of biocompatible materials. This study employed machine learning and molecular simulations to identify MOFs suitable for encapsulating gemcitabine, paclitaxel, and SN‐38, and identified PCN‐222 as an optimal candidate. Following drug loading, MOF formulations are improved for colloidal stability and biocompatibility. In vitro studies on pancreatic cancer cell lines have shown high biocompatibility, cellular internalization, and delayed drug release. Long‐term stability tests demonstrated a consistent performance over 12 months. In vivo studies in pancreatic tumor‐bearing mice revealed that paclitaxel‐loaded PCN‐222, particularly with a hydrogel for local administration, significantly reduced metastatic spread and tumor growth compared to the free drug. These findings underscore the potential of PCN‐222 as an effective drug delivery system for the treatment of hard‐to‐treat cancers.

854

News (Medical) associated with Gemcitabine Hydrochloride

12 Feb 2026

·www.fiercebiotech.com

Langer-backed biotech looks to end cancer recurrence with surgical revolution

Surge Therapeutics just dosed the final patient in a phase 1 trial of its breast cancer candidate, which is meant to be given during tumor-removal surgery. From left to right: Surge founder and CEO Michael Goldberg, Ph.D.; Freya Schnabel, M.D., director of breast surgery at NYU; Acacia Sharma, research project manager at NYU; and Shane Roberts, field clinical manager at Surge.\n For all of the groundbreaking advancements in cancer treatment over the last decades, the first step for tackling almost all solid tumors is still surgery. If the cancer comes back, medicines like immunotherapies can then be given systemically to eradicate the tumor’s remnants. For Surge Therapeutics, this separation of surgery and medicine makes no sense.Feb. 10, Surge dosed the final patient in its phase 1 trial of SRG-514, a breast cancer candidate that, like the rest of the biotech’s pipeline, is meant to be injected directly into the tumor site by the surgeon during an operation. The company now plans to bring the candidate into a pivotal phase 3 study this summer, founder and CEO Michael Goldberg, Ph.D., told Fierce Biotech.Surge was founded on a seemingly simple premise—giving patients anticancer medicine at the same time their cancer is surgically removed—but it’s one that has the potential to be transformative, Goldberg said.“The surgeon goes in, he cuts out the tumor, and then sutures up the patient and sends them home,” he said. “That doesn\'t make a lot of sense to me, to leave that space empty when we could be filling it with medicine.”It didn’t make a lot of sense to Goldberg’s mentor, acclaimed scientist and biotech entrepreneur Robert Langer, either. Langer, an MIT professor perhaps best known for cofounding mRNA giant Moderna, is now chair of Surge’s scientific advisory board.“To me, it’s a natural thing,” Langer told Fierce. Goldberg has pioneered methods to give immunotherapy locally, he said, and Surge has “incredible safety data so far.” SRG-514 is a unique formulation of an anti-inflammatory drug called ketorolac, which is usually given to patients after surgery has wrapped up. By instead targeting the med to where the patient’s tumor actually is in their body, Surge hopes to fully eradicate any lingering cancer cells and prevent deadly recurrence of the disease.Surge’s other programs, STM-416 and STM-416p, look to do something similar with antitumor drug resiquimod in bladder cancer and prostate cancer. Both are set to enter phase 2 studies this year, Goldberg said.The Massachusetts-based biotech’s approach builds on Langer’s long history of innovation in drug delivery. Langer and another former student previously cofounded Taris Biomedical to advance a silicone-based system that can be inserted into the bladder to continuously release anticancer medicine. Johnson & Johnson acquired that company in 2019, and the bladder cancer candidate was approved in 2025 as Inlexzo.Should Surge succeed in its mission, the potential impact could be enormous.“There are 9 million cancer patients each year who undergo surgical tumor resection,” Goldberg explained. “Approximately 40% of them will recur within five years, and 90% of cancer-related mortality is owing to recurrence or metastasis.”To Goldberg, that makes cancer recurrence the “single biggest unmet need in oncology,” he said.Beyond the numbers, Goldberg also has a personal connection to Surge’s mission. He has lost multiple friends to cancer that came back after surgery, he told Fierce.“The mission that we have is to create a world where nobody grieves the loss of a loved one to preventable postsurgical cancer recurrence,” Goldberg said.Langer’s confidence in Surge’s approach is bolstered by his close relationship with his former student Goldberg. For the biotech veteran, it’s important to support the next generation of industry leaders alongside backing big science breakthroughs.“I want to see as many good things that will help the world as possible,” Langer told Fierce. Alongside “transformative science,” he wants to “train great people and make sure that as much of that great science gets out to the world as possible.”This desire also explains Langer’s recent cofounding of Soufflé Therapeutics, a mysterious RNA startup that arose in October 2025 with $200 million and multiple Big Pharma partnerships in the oven. Langer’s daughter Susan is founding president and chief business officer of the venture, and his former student Amir Nashat is CEO.When it comes to launching new biotechs like Soufflé and Surge, Langer and Goldberg both recognize that things are different now—especially for vaccine companies like Moderna. But both also believe that, ultimately, science and meritocracy will prevail.“If you have great ideas, if you have outstanding data, there will be a path to success,” Goldberg said.Over Langer’s close to 50 years in biotech, the industry has “gone up and down, up and down, up and down,” he said. But the overall trajectory has been up, and at the end of the day, “science will win.”

Phase 1ImmunotherapyAcquisition

12 Feb 2026

·www.biospace.com

Valar Labs Publishes Pivotal Study in Journal of Clinical Oncology Validating AI to Predict Chemotherapy Response for Pancreatic Cancer Patients

New AI diagnostic, Vitara Pancreas ChemoPredict, can select optimal first-line treatment for advanced pancreatic cancer patients. PALO ALTO, Calif.--(BUSINESS WIRE)--Valar Labs, a leader in computational histology and precision oncology, today announced the publication of a major study in the Journal of Clinical Oncology (JCO) , a premier, peer-reviewed medical journal published by the American Society of Clinical Oncology . The report, appearing in the Journal of Clinical Oncology (JCO) , uses Valar Labs’ proprietary AI algorithm that analyzes standard H&E-stained pathology slides—universally available for almost every cancer patient—to identify distinct histological signatures in pancreatic cancer that correlate with response to specific therapies. "This study proves that there is a wealth of predictive information hidden within standard pathology images that the human eye cannot quantify, but AI can," said Viswesh Krishna, Co-founder and CTO of Valar Labs. Pancreatic cancer remains a difficult-to-treat disease and currently, oncologists have limited tools to decide between the two standard-of-care, first-line chemotherapy options (FOLFIRINOX vs. Gemcitabine/Nab-Paclitaxel), often relying on patient performance status rather than tumor biology. This trial-and-error approach can cost patients valuable time and expose them to unnecessary toxicity. The paper, titled “Development and Validation of a Computational Histology Artificial Intelligence-Powered Predictive Biomarker for Selection of Chemotherapy in Advanced Pancreatic Cancer,” details the development and rigorous validation of Valar Labs’ Vitara Pancreas AI diagnostic test. The study demonstrates the AI’s ability to accurately predict patient response to specific first-line chemotherapy regimens, addressing a critical unmet need in one of the deadliest forms of cancer. "Publication in the Journal of Clinical Oncology is a significant milestone that underscores the scientific rigor and clinical validity of our approach," said Anirudh Joshi, Co-founder and CEO of Valar Labs . "For too long, first-line treatment decisions in advanced pancreatic cancer have been a bit of a guessing game. By validating our technology with high-quality data from PanCAN and the COMPASS trial, we can provide oncologists with a tool to personalize care and potentially improve outcomes for thousands of patients." The study utilized data from two prospective cohorts to validate the AI biomarker: PanCAN’s Know Your Tumor® initiative: A precision medicine service offered by the Pancreatic Cancer Action Network (PanCAN) that has pioneered molecular profiling for pancreatic cancer patients, accessed via PanCAN’s SPARK health data platform. The COMPASS clinical trial: A renowned prospective trial focused on genomics-driven precision medicine for advanced pancreatic cancer. “This work reflects how AI has the potential to move the field forward by helping guide treatment decisions,” said Anna Berkenblit, MD, MMSc, PanCAN Chief Scientific and Medical Officer. “By leveraging de-identified patient health data in the PanCAN SPARK health data platform, this initiative underscores how AI-driven data discoveries can not only accelerate research but can also lead to improved patient outcomes,” said Kawther Abdilleh, PhD, PanCAN Director, Data Science and Informatics and co-author. Following this biomarker validation, Valar Labs is pleased to make the Vitara Pancreas ChemoPredict test available under early access to oncologists for advanced pancreatic cancer patients. Participating providers can order the test to gain actionable insights into which first-line chemotherapy regimen is most likely to benefit each patient. "Biomarkers to guide choice of first-line chemotherapy in advanced pancreatic cancer have been a decades-long goal for the pancreatic cancer community,” said Dr. Andrew Hendifar, Pancreatic Cancer Medical Director at Cedars Sinai Samuel Oschin Cancer Center, and lead author of the study. “We are excited to share results validating a predictive AI biomarker for this important clinical decision and look forward to integrating the Vitara Pancreas test into our clinical decision making for patients." Valar Labs is a recognized leader in AI-driven diagnostics for genitourinary cancers, with its flagship Vesta bladder cancer portfolio in use across dozens of leading health systems and cancer centers nationwide. The successful validation of Vitara Pancreas and its availability mark Valar Labs’ expansion into gastrointestinal cancers, further establishing the company as a multi-tumor oncology platform committed to transforming cancer care through artificial intelligence. Article: Development and Validation of a Computational Histology Artificial Intelligence-Powered Predictive Biomarker for Selection of Chemotherapy in Advanced Pancreatic Cancer For more information on the study or testing for clinical care, please visit . About Valar Labs Valar Labs is a precision oncology company using artificial intelligence to reduce the uncertainty in cancer treatment. By analyzing standard pathology slides, Valar’s AI biomarkers predict response to therapy, enabling more personalized and effective treatment decisions. Contacts Media Relations +1 (888) 862-0232 media@valarlabs.com

ASCO

12 Feb 2026

·www.biospace.com

FDA Approves First-of-Its-Kind Device to Treat Pancreatic Cancer

Device Delivers Non-invasive Therapy and Supports Care at Home White Oak, Md., Feb. 12, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration has approved a first-of-its-kind device for the treatment of adult patients with locally advanced pancreatic cancer. Optune Pax, developed by Novocure, is a portable, non-invasive device that delivers alternating electrical fields, known as tumor treating fields (TTFields), to the abdomen. TTFields work by physically disrupting the rapid cell division that is characteristic of cancer cells, while minimizing damage to healthy tissue. “Having treated many patients with pancreatic cancer, I know how difficult the diagnosis can be. The pancreatic cancer community deserves better therapeutic options,” said FDA Commissioner Marty Makary, M.D., M.P.H. “The FDA is working tirelessly to bring potentially promising therapies to people who need them.” The approval reflects the FDA’s unwavering commitment to advancing safe and effective medical devices that address chronic diseases and improve the lives of Americans and is also aligned with the FDA’s Home as a Health Care Hub Initiative , which focuses on advancing the development of innovative, patient-centered devices that fit more seamlessly into people’s daily lives at home. “Pancreatic cancer is one of the most challenging cancers to treat, and patients have long needed new therapeutic options,” said Center for Devices and Radiological Health Director Michelle Tarver, M.D., Ph.D. “This approval provides a novel, non-invasive approach that can be integrated into patients’ daily lives, expanding access to cancer care beyond traditional clinical settings.” According to information published by the National Cancer Institute , pancreatic cancer was expected to result in approximately 67,440 new diagnoses and 51,980 deaths in the U.S. in 2025. Pancreatic cancer accounts for roughly 3.3% of all new cancer cases but represents a disproportionately large share of cancer deaths due to its late detection, aggressive disease behavior, and limited treatment options. The therapy is administered through electrically insulated adhesive patches that are placed on the patient’s skin and connected to an electric field generator. Device treatment technological parameters are preset by the manufacturer and cannot be adjusted by the patient or physician. Patients are trained on how to use the device, including how to recharge and replace device batteries, connect the device to an external power supply, place the adhesive patches in the appropriate positions on the body, and replace the transducer arrays at least twice per week. The device is designed to be worn with the generator carried in a specially designed bag, allowing patients to receive continuous treatment while going about their normal daily activities. Optune Pax was approved through the premarket approval (PMA) pathway, the FDA’s most rigorous review process for medical devices. The FDA’s approval of Optune Pax is based on data from a pivotal clinical study conducted under an Investigational Device Exemption. The randomized and controlled study followed adult patients with locally advanced pancreatic cancer for up to five years. The results showed that the addition of TTFields to standard of care chemotherapies gemcitabine and nab-paclitaxel (GnP) improved Overall Survival by approximately two months compared to GnP alone. Localized skin reactions were the most common device-related risks observed in the study. The results of this study formed the basis for the FDA’s PMA approval decision. The FDA granted Breakthrough Device designation for the Optune Pax device in December 2024. A breakthrough designation is meant to expedite the development and review of devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Contact Info U.S. Food and Drug Administration FDAPressAlerts@fda.hhs.gov +1 202-690-6343

Clinical ResultBreakthrough Therapy

100 Deals associated with Gemcitabine Hydrochloride

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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
Non-Muscle Invasive Bladder Neoplasms	United States	Janssen Biotech, Inc.	09 Sep 2025
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
Bladder Cancer	Brazil	Libbs Farmacêutica Ltda.	26 May 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
Advanced biliary tract cancer	Phase 3	Taiwan Province	InnoPharmax, Inc.	01 Jul 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


NCT03693807 (CTgov)	Phase 2	Colorectal Liver Metastases \| Colorectal Cancer \| Bile Duct Neoplasms	35	Cetuximab+Gemcitabine+Floxuridine (FUDR)+Oxaliplatin+Irinotecan (CPT-11)+Panitumumab+Fluorouracil (Group 1: Unresectable Liver Metastases From Colorectal Cancer)	aiytkdipmh(avxchgsfai) = thlfkydail cwvqcgpuic (fcyunowvhl, ygwvxuicrx - pcqynauevw) View more	-	06 Feb 2026
				Cetuximab+Gemcitabine+Floxuridine (FUDR)+Oxaliplatin+Irinotecan (CPT-11)+Panitumumab+Fluorouracil (Group 2: Resectable Liver Metastases From Colorectal Cancer)	aiytkdipmh(avxchgsfai) = xhuxttcmxb cwvqcgpuic (fcyunowvhl, pxrlfxfazk - svontmfkkh) View more
NCT04524702 (CTgov)	Phase 2	Pancreatic adenocarcinoma metastatic \| Advanced Pancreatic Adenocarcinoma	10	Hydroxychloroquine+Nab-paclitaxel+Gemcitabine+Paricalcitol	baqveewonl = qcexwgpejv nkdakelylx (kjlnnjjevg, crcfrjzhfy - cgqntkroru) View more	-	23 Jan 2026
NCT03377491 (PANOVA-3, CTgov)	Phase 3	Pancreatic Adenoma \| Locally Advanced Pancreatic Adenocarcinoma	571	Nab-paclitaxel+Gemcitabine (TTFields + Standard of Care)	hvluavrxnk(vkokwurpeh) = uzqnlqwgwb ivsfpacmpu (kuuyknhyzp, nagqdxceja - egeunhgzpo) View more	-	21 Jan 2026
				Nab-paclitaxel+Gemcitabine (Standard of Care)	hvluavrxnk(vkokwurpeh) = akbzywtfgd ivsfpacmpu (kuuyknhyzp, xbgfpovmxa - jwewzthdyp) View more
NCT03943667 (GEMPAX, CTgov)	Phase 3	Pancreatic adenocarcinoma metastatic \| Metastatic Pancreatic Ductal Adenocarcinoma	211	Paclitaxel+Gemcitabine (GEMPAX)	nfktdxcnze(ozyxdvlgis) = nmgdkqvlkw zviggjskmb (zciqzggzjw, agehmedojo - zoeiwztxog) View more	-	15 Jan 2026
				Gemcitabine (Control)	nfktdxcnze(ozyxdvlgis) = ksasfyamug zviggjskmb (zciqzggzjw, qtxrmezcdl - hycstfuhvh) View more
NCT04539808 (NeoOPTIMIZE, CTgov)	Phase 2	Pancreatic adenocarcinoma \| Pancreatic Ductal Adenocarcinoma	42	mFOLFIRINOX+nab-paclitaxel+leucovorin calcium+gemcitabine hydrochloride+potassium+losartan+Oxaliplatin+irinotecan hydrochloride+capecitabine+fluorouracil	jxfjgfwmzj = frkgjrbhlo yogvwsqimn (hsrrfwocci, jxkseauksk - skpazgwdsr) View more	-	14 Jan 2026
ASCO_GI2026	Not Applicable	Pancreatic adenocarcinoma metastatic First line	6,279	FOLFIRINOX	ohyqukaxhc(xvyyhxnsfz) = rsvcijnzls mtwkoqmdqw (smmhisgqdr, 10.2 - 12.1)	Negative	08 Jan 2026
				Gem-Nab	ohyqukaxhc(xvyyhxnsfz) = ailrewzjrk mtwkoqmdqw (smmhisgqdr, 8.0 - 9.4)
ASCO_GI2026	Not Applicable	Advanced biliary tract cancer First line	172	Gemcitabine-cisplatin-durvalumab (GCD) (low-risk)	xdhzgpztud(rpsqqyghkm) = Magic-D achieved AUCs of 0.755 and 0.749 for 6- and 12- months survival prediction, respectively, outperforming NLR and other baseline factors. yaeygcriep (ypetwhnwqv )	Positive	08 Jan 2026
				Gemcitabine-cisplatin-durvalumab (GCD) (intermediate-risk)
ASCO_GI2026	Not Applicable	Biliary Tract Neoplasms First line	148	gemcitabine + cisplatin + immune checkpoint inhibitor	uyxltcctxk(jzglqmurcf) = ohbdkjywrm ztwoxrkyjb (klmsmsblzp, 10.6 - 16.4) View more	Positive	08 Jan 2026
				gemcitabine + cisplatin + S-1	uyxltcctxk(jzglqmurcf) = vwplyhluub ztwoxrkyjb (klmsmsblzp, 8.5 - 13.5) View more
NCT03678883 (1801 Part 3B, ASCO_GI2026)	Phase 2	Metastatic Pancreatic Cancer First line KRAS \| TP53 \| CDKN2A	170	Elraglusib/Gemcitabine/nab-paclitaxel	ucqvzvuxtv(hhtrprumoj) = KRAS and TP53 gene mutations were associated with worse overall survival (OS) in patients treated with elraglusib/GnP (p<0.05) but not in GnP-treated patients. slxwtyfgnm (hxbihtcwac )	Positive	08 Jan 2026
				Gemcitabine/nab-paclitaxel
NCT04203160 (BilT-04, CTgov)	Phase 1/2	Unresectable Biliary Tract Carcinoma	75	Gemcitabine+cisplatin	jvtapjrknz = nvmshfatgs pffmnwkwps (robmytbrhb, dnntwebhxh - jqsdbmgvfl) View more	-	31 Dec 2025