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Last update 28 Jul 2025

Irinotecan Hydrochloride

Last update 28 Jul 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

ASC-201 - Ascelia Pharma, irinotecan, Irinotecan hydrochloride (USP)

+ [36]

Target

Top I

Action

inhibitors

Mechanism

TOP1 inhibitors(DNA topoisomerase I inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesDigestive System Disorders+ [7]

Active Indication

Childhood Malignant Solid NeoplasmIntestinal NeoplasmsColonic Cancer+ [29]

Inactive Indication

AdenocarcinomaAdenocarcinoma of EsophagusAdenocarcinoma of large intestine+ [62]

Originator Organization

Yakult Honsha Co., Ltd.

Active Organization

Genentech, Inc.Valent Technologies LLC

Eli Lilly & Co.

+ [11]

Inactive Organization

AstraZeneca PLCRoche Pharma AG

Bristol Myers Squibb Co.

+ [13]

License Organization

Hanmi Pharmaceutical Co., Ltd.Athenex Pharmaceuticals Co. Ltd.

Daiichi Sankyo Co., Ltd.

+ [5]

Drug Highest PhaseApproved

First Approval Date

Japan (19 Jan 1994),

Non-Small Cell Lung CancerOvarian CancerPancreatic Cancer+ [3]

RegulationAccelerated Approval (United States), Priority Review (China)

Structure/Sequence

Molecular FormulaC33H45ClN4O9

InChIKeyKLEAIHJJLUAXIQ-JDRGBKBRSA-N

CAS Registry136572-09-3

1,551

Clinical Trials associated with Irinotecan Hydrochloride

NCT06998940

/ Not yet recruitingPhase 3IIT

Randomized Phase III Study of Second-Line Chemotherapy With or Without Panitumumab for KRAS Wild Type, Locally Advanced or Metastatic Pancreatic Adenocarcinoma

This phase III trial compares the effect of adding panitumumab to standard chemotherapy (with nanoliposomal Irinotecan, leucovorin, and 5-fluorouracil [5-FU] or irinotecan, leucovorin, and 5-FU or nab-paclitaxel and gemcitabine) versus standard chemotherapy alone in treating patients with KRAS wild type (WT) pancreatic ductal adenocarcinoma that cannot be removed by sugery (unresectable) or that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Panitumumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Chemotherapy drugs, such as nanoliposomal irinotecan, leucovorin, 5-FU, irinotecan, nab-paclitaxel and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding panitumumab to standard chemotherapy may be effective in treating patients with unresectable, locally advanced, or metastatic KRAS WT pancreatic ductal adenocarcinoma.

Start Date06 Jan 2026

Sponsor / Collaborator

SWOG

[+1]

NCT06820957

/ Not yet recruitingPhase 2/3IIT

Randomized Phase 2/3 Trial of Vincristine-Irinotecan-Regorafenib in Combination With Vincristine-Doxorubicin-Cyclophosphamide (VDC) and Ifosfamide-Etoposide (IE) in Patients With Newly Diagnosed Metastatic Ewing Sarcoma

This phase II/III trial compares the effect of vincristine, irinotecan, and regorafenib (VIrR) in combination with vincristine, doxorubicin, cyclophosphamide (VDC), ifosfamide and etoposide (IE) to usual treatment with VDC/IE for the treatment of newly diagnosed Ewing sarcoma or other round cell sarcomas that have spread from where they first started (primary site) to other places in the body (metastatic). Vincristine is in a class of medications called vinca alkaloids. It works by stopping tumor cells from growing and dividing and may kill them. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill tumor cells. Regorafenib, a type of kinase inhibitor and a type of antiangiogenesis agent, blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill tumor cells. It may also lower the body's immune response. Ifosfamide, a type of alkylating agent and a type of antimetabolite, attaches to DNA in cells and may kill tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Giving VIrR/VDC/IE may be more effective than usual treatment with VDC/IE in treating patients with newly diagnosed metastatic Ewing sarcoma or other round cell sarcomas.

Start Date13 Sep 2025

Sponsor / Collaborator

The Children's Oncology Group Foundation, Inc.

NCT06846346

/ Not yet recruitingPhase 2IIT

Phase II Study Evaluating Ivonescimab in Combination With Chemotherapy for First- and Second-line Treatment of Advanced or Metastatic Gastric and Gastroesophageal Adenocarcinoma Patients

The goal of this clinical trial is to evaluate the addition of ivonescimab to standard chemotherapy in patients with advanced or metastatic gastric and gastroesophageal adenocarcinoma. The main question it aims to answer is : Does the addition of ivonescimab increase the response to treatment ? Participants will visit the clinic every 2 weeks for checkups, treatment administration and tests for collection of adverse events.

Start Date01 Sep 2025

Sponsor / Collaborator

UNICANCER

[+1]

100 Clinical Results associated with Irinotecan Hydrochloride

100 Translational Medicine associated with Irinotecan Hydrochloride

100 Patents (Medical) associated with Irinotecan Hydrochloride

12,494

Literatures (Medical) associated with Irinotecan Hydrochloride

31 Dec 2025·AUTOIMMUNITY

Deciphering distinct pathogenic mechanisms of ankylosing spondylitis and systemic sclerosis via shared biomarkers ZSWIM6 and CCL3L3: Insights from an integrative bioinformatics approach

Article

Author: Zhou, Chenxing ; Chen, Jiarui ; Zhan, Xinli ; Xue, Jiang ; Shi, Jianjun ; Zhou, Zhongxian ; Yang, Renbang ; Huang, Liangyu ; Huang, Chengqian ; Liu, Chong ; Chen, Tianyou ; Feng, Sitan ; Huang, Jieping ; Wu, Shaofeng ; Zhu, Jichong

Ankylosing Spondylitis (AS) and Systemic Sclerosis (SSc) are both autoimmune diseases, albeit with distinct anatomical targets. AS primarily affects the spine and sacroiliac joints, triggering inflammation and eventual fusion of the vertebrae. SSc predominantly impacts the skin and connective tissues, leading to skin fibrosis, thickening, and potential damage to vital organs such as the lungs, heart, and kidneys. Despite their differing anatomical manifestations, inflammation serves as a pivotal factor in both conditions. Exploring the causes of the different pathogenesis of inflammation in AS and SSc could provide new insights into their treatment. We selected RNA-seq profiles of peripheral blood mononuclear cells (PBMCs) from the GEO datasets GSE73754 and GSE19617. DEGs were identified using the Limma R package with an adjusted p-value cutoff of < 0.05. Gene Ontology pathway analysis, SVM recursive feature elimination, and Gene Set Enrichment Analysis (GSEA) were conducted to analyze the DEGs. CIBERSORT was applied to estimate immune cell composition and its correlation with hub genes. Single-cell RNA sequencing data from peripheral blood mononuclear cells in the GSE194315 dataset were included to support differential expression analysis and biomarker identification. Additionally, single-cell RNA sequencing data from bone marrow blood samples were utilized to further validate these findings, offering complementary insights into biomarker expression across distinct sample types. A total of 762 DEGs were identified between AS patients and controls, and 441 DEGs between SSc patients and controls. Both conditions showed enrichment in the Natural killer cell mediated cytotoxicity pathway. ZSWIM6 and CCL3L3 were identified as potential biomarkers in AS and SSc, with significant diagnostic capabilities demonstrated by ROC analysis. Correlation analysis revealed associations between these biomarkers and specific immune cell types. The study utilizing ZSWIM6 and CCL3L3 as potential biomarkers provides deep insights into the distinct molecular mechanisms of SSc and AS. These findings lay the foundation for future research on targeted therapies and enhance our understanding of immune cell interactions in these autoimmune diseases.

01 Sep 2025·TOXICOLOGY AND APPLIED PHARMACOLOGY

Tectorigenin alleviates irinotecan-induced intestinal inflammation by activating the Nrf2/Keap1 pathway and synergistically enhances the anti-colon cancer efficacy of irinotecan

Article

Author: Zhang, Chaojun ; Ma, Rui ; Zou, Guijun ; Zheng, Peng ; Liu, Xiaoya

BACKGROUND:

Gastrointestinal toxicity, primarily manifesting as colitis, is one of the most common adverse events during irinotecan (CPT-11) treatment for colon cancer, significantly impacting therapeutic efficacy and the general condition of patients. Tectorigenin (TEC) is a flavonoid compound extracted from Bupleurum and saponins, which are traditional Chinese medicines with anti-inflammatory properties. Previous experiments have found that it can alleviate CPT-11-induced diarrhoea and synergistically inhibit tumor growth with CPT-11, but the specific mechanisms remain unknown.

METHODS:

A CPT-11-induced diarrhoea mouse model was used to study the protective effect of TEC on CPT-11-induced diarrhoea in mouse by measuring levels of inflammatory cytokines and intestinal tight junction-related proteins in colon tissues. The chemopreventive effect of TEC was evaluated by measuring levels of inflammatory cytokines and intestinal tight junction-related proteins in Caco-2 cells exposed to CPT-11 and lipopolysaccharide (LPS). Finally, the synergistic effect of TEC combined with CPT-11 on tumor growth was investigated in a mouse model of colon tumors induced by subcutaneous implantation of CT26 colon cancer cells.

RESULTS:

TEC inhibited CPT-11-induced intestinal toxicity, as evidenced by reduced weight loss, decreased diarrhoea scores, and less intestinal shortening in mouse. Histological analysis demonstrated that TEC alleviated CPT-11-induced intestinal barrier damage. Additionally, TEC activated the nuclear factor erythroid 2-related factor 2/Kelch-like ECH-associated protein 1 (Nrf2/Keap1) signalling pathway, reduced the expression of inflammatory cytokines both in vivo and in vitro, alleviated intestinal inflammation, and increased the expression of intestinal tight junction proteins, thereby enhancing intestinal barrier function. Furthermore, TEC exhibited a synergistic effect with CPT-11 in anti-tumor therapy.

CONCLUSIONS:

This study confirmed that TEC alleviates CPT-11-induced intestinal inflammation by activating the Nrf2/Keap1 signalling pathway and enhances the anti-tumor effect of CPT-11 in colon cancer.

01 Aug 2025·INTERNATIONAL JOURNAL OF PHARMACEUTICS

Local drug delivery of irinotecan with phosphatidyldiglycerol-based thermosensitive liposomes reduces systemic exposure and increases therapeutic efficacy compared to systemic drug and Onivyde®

Article

Author: Wedmann, Barbara ; Lindner, Lars H ; Pointner, Lisa ; Hossann, Martin ; Winter, Gerhard ; Kort, Simone

Thermosensitive Liposomes (TSL) represent a promising tool for targeted drug delivery in combination with local hyperthermia (HT). Irinotecan (CPT-11) is approved for the treatment of various solid tumors but is rapidly metabolized after i.v. injection impairing intratumoral uptake. CPT-11 was therefore encapsulated in phosphatidyldiglycerol-based TSL (DPPG₂-TSL-CPT-11) to extend its blood stability and to intravascularly release CPT-11 in the tumor. In vitro, DPPG₂-TSL-CPT-11 demonstrated efficient drug retention at ≤ 39 °C and fast CPT-11 release at > 40 °C in presence of serum. DPPG₂-TSL-CPT-11 showed a CPT-11 plasma half-life of 1.57 h in rats compared to 0.71 h for non-liposomal CPT-11 and 18.70 h for PEGylated non-thermosensitive CPT-11 (Onivyde®), respectively. Systemic exposure of the active metabolite SN-38 was reduced by DPPG₂-TSL-CPT-11 compared to Onivyde®. One hour of HT treatment in combination with DPPG₂-TSL-DOX delivered 24-fold and 36-fold more CPT-11 into tumors than Onivyde® and non-liposomal CPT-11, respectively. DPPG₂-TSL-DOX and Onivyde® showed a comparable overall survival, superior (p < 0.005) to non-liposomal CPT-11. DPPG₂-TSL-DOX was the only formulation that led to a tumor size reduction. In vivo data indicated an advantage of the intravascular CPT-11 release over systemic drug application or passive tumor accumulation of liposomes.

556

News (Medical) associated with Irinotecan Hydrochloride

21 Jul 2025

·www.globenewswire.com

Actuate Therapeutics Advances Clinical Program in Ewing Sarcoma After Positive Phase 1 Trial Demonstrates Complete and Partial Responses in Difficult-to-Treat Pediatric Sarcomas

- Announces Completion of Phase 1 Study of Elraglusib in Pediatric Patients - Prolonged and Durable Complete Responses (CRs) Observed in Two of Ten Refractory Ewing Sarcoma Patients - Two Additional Patients Had Durable Stable Disease in Notoriously Difficult-to-Treat Cancer - Confirmed Partial Response (PR) in a patient with a desmoplastic small-round-cell tumor (DSRCT) - Company Initiating Planning of Phase 2 Trial of Elraglusib in Children, Adolescents, and Adults with Refractory/Resistant Ewing Sarcoma July 17, 2025 -- Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), today announced the end of the Phase 1 portion of its clinical study evaluating elraglusib monotherapy or in combination with irinotecan, irinotecan plus temozolomide, or with cyclophosphamide plus topotecan in pediatric patients with refractory malignancies (Actuate-1902). Following encouraging signals of activity, particularly in treatment-refractory Ewing Sarcoma (EWS), a small round cell sarcoma that forms in soft tissue and bone, the Company will seek to advance the clinical development program towards a Phase 2 study in children, adolescents, and adults with relapsed/refractory EWS. “Refractory and resistant EWS is one of the most aggressive and underserved cancers affecting children and young adults with very low survival rates,” said Dr. Andrew Mazar, Actuate’s Scientific Co-founder and Chief Operating Officer. “To observe complete responses in this setting is highly unexpected, and these exceptional early results position elraglusib as a potential first-in-class therapy option in an indication where no approved targeted therapies currently exist.” The Phase 1/2 Trial (NCT 04239092), also referred to as Actuate-1902, was an open-label, multicenter study evaluating the safety and efficacy of elraglusib in pediatric patients with relapsed/refractory malignancies, including EWS and other pediatric sarcomas. To date, the study has enrolled ten (10) patients with relapsed/refractory EWS (>1 remission) treated with the combination of elraglusib and topotecan/cyclophosphamide. “We are highly encouraged by the responses observed in refractory and resistant EWS, a disease where treatment options are extremely limited beyond frontline chemotherapy,” said Daniel Schmitt, President & Chief Executive Officer of Actuate. “With these promising clinical signals in hand, we are advancing our development plans focused on EWS by pursuing a Phase 2 trial and plan to meet with regulators to discuss potential registration path in this indication.” Of the ten (10) EWS patients enrolled, two (2) patients achieved complete responses by CT and/or complete metabolic responses (CR/CMR), while two (2) had confirmed stable disease. A partial response (PR) was also observed in one patient with a desmoplastic small-round-cell tumor (DSRCT), a small round cell sarcoma that forms in soft tissue. While the sample size specific to Ewing Sarcoma in the 1902 study was small, the responses are viewed as positive evidence of anti-tumor activity in this difficult-to-treat indication, and Actuate plans to further investigate elraglusib’s ability to positively change patients’ potential for successful treatment in a Phase 2 trial in pediatric, adolescent, and adult patients with relapsed/refractory Ewing Sarcoma. The Company is collaborating with key opinion leaders and consortiums with interest in EWS to ensure the design of the upcoming study aligns with both patient needs and regulatory expectations. The Company expects to initiate the trial in 2026, subject to available funding. Ewing sarcoma (EWS) is a highly metastatic form of sarcoma with a peak incidence at the age of 15, that ranks as the second most prevalent primary malignant tumor of childhood and adolescence. Approximately 25% of new EWS patients have metastatic disease when first diagnosed, which is the most significant predictor of poor survival. Actuate is a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers. Actuate’s lead investigational drug, elraglusib (a novel GSK-3β inhibitor), targets molecular pathways in cancer that are involved in promoting tumor growth and resistance to conventional cancer drugs such as chemotherapy through the inhibition of nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and DNA Damage Response (DDR). Elraglusib may also mediate anti-tumor immunity through the regulation of multiple immune checkpoints and immune cell function. The content above comes from the network. if any infringement, please contact us to modify.

Clinical Result

17 Jul 2025

·momatx.com

MOMA Therapeutics Announces First Patient Dosed in Phase 1 Clinical Trial for MOMA-341,a Highly Potent and Selective Werner Helicase Inhibitor

Share – First-in-human study of MOMA-341 focuses on advanced or metastatic solid tumors with high microsatellite instability – – MOMA-341 is a highly differentiated, potentially best-in-class oral covalent Werner helicase inhibitor with a novel chemical scaffold identified via the KNOMATIC™ platform – CAMBRIDGE, Mass., July 17, 2025— MOMA Therapeutics, a clinical-stage biopharmaceutical company discovering and developing a new generation of precision therapeutics, today announced that the first patient has been dosed in its Phase 1 clinical trial to assess the safety and tolerability of MOMA-341, a potent and selective Werner helicase inhibitor with a novel chemical scaffold. MOMA-341 is being developed as a monotherapy and in combination with chemotherapy or immunotherapy for the treatment of advanced or metastatic solid tumors that exhibit high microsatellite instability (MSI-H) and/or DNA mismatch repair deficiency (dMMR), including colorectal, gastric and endometrial cancers. The fact that Werner helicase is required for survival of MSI-H/dMMR tumor cells makes it a promising emerging drug target. MOMA anticipates an initial readout of monotherapy data in mid-2026. “We are proud to enter the clinic for the second time in less than a year, with initial readouts for both MOMA-341 and MOMA-313, our novel Polθ helicase inhibitor, expected in early-to- mid 2026,” said Asit Parikh, M.D., Ph.D., chief executive officer of MOMA. “Given that MOMA-341’s novel chemical scaffold confers excellent target coverage, we are eager to evaluate its best-in-class potential for patients through this Phase 1 study.” About the MOMA-341 Phase 1 Trial The Phase 1 clinical trial is a global multi-center, open-label dose escalation and dose optimization study (NCT06974110) designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical activity of MOMA-341 as an orally administered single agent or combination therapy with either the chemotherapy agent irinotecan or immunotherapy. Adult participants must have unresectable advanced or metastatic microsatellite instability high (MSI-H) or DNA mismatch repair deficiency (dMMR) solid tumors. About the KNOMATIC™ platform MOMA-341 and MOMA-313, were discovered and developed through the application of MOMA’s KNOMATIC platform. The KNOMATIC platform integrates deep structural insights, advanced hit-finding technologies and computation-enabled lead optimization to accelerate discovery of novel therapeutics targeting families of highly dynamic proteins, such as ATPases and GTPases. About MOMA Therapeutics MOMA Therapeutics is a clinical-stage, next-generation precision medicine company dedicated to targeting highly dynamic proteins that underlie human disease via a small molecule approach, utilizing its proprietary KNOMATIC™ platform. The platform was designed to exploit key vulnerabilities inherent to all dynamic proteins, namely their dependence on well-coordinated, stepwise changes in protein conformation. By focusing on genetically validated targets with high translation potential, MOMA is rapidly advancing its pipeline toward responses in the clinic. MOMA has existing discovery partnerships with Roche and Bayer, as well as a wholly owned discovery pipeline. For more information on MOMA, go to www.momatx.com. Media Contact Katie Engleman katie@1abmedia.com

Phase 1Immunotherapy

01 Jul 2025

·www.globenewswire.com

Processa Pharmaceuticals Provides Portfolio and Business Update

Signed binding term sheet granting Intact Therapeutics an exclusive option to license PCS12852Continue enrolling patients in Phase 2 study of PCS6422Strengthened balance sheet with $7M capital infusion VERO BEACH, Fla., July 01, 2025 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical-stage pharmaceutical company developing next-generation cancer therapies, provides updates on its product pipeline, upcoming milestones and business activities. “We are taking deliberate steps to focus our resources on programs with the highest potential for clinical success and commercial impact,” said Dr. David Young, President Research and Development at Processa. “Our approach continues to center on developing safer, more effective treatments for cancer while creating value through strategic business development and disciplined pipeline management.” “Our NGC-Cap Phase 2 clinical trial in metastatic breast cancer is actively enrolling patients. We continue to anticipate sharing initial data in the second half of 2025,” said George Ng, Chief Executive Officer of Processa Pharmaceuticals. “The streamlining of our development pipeline, signing of strategic partnerships, and optimizing our capital allocation, enable us to make the necessary investments in our science in order to enhance shareholder value.” Key Portfolio Updates: PCS6422 (NGC-Cap): PCS6422, Processa’s lead oncology asset in combination with capecitabine (NGC-Cap), is actively enrolling patients in a Phase 2 study for metastatic breast cancer. The program remains a top priority, with the remaining patients needed for the pre-planned interim analysis expected to be enrolled in the second half of 2025. The trial builds on compelling safety and efficacy signals observed in earlier studies, including improved tolerability and increased exposure to active cancer-killing metabolites.PCS499: Based on preliminary positive results in kidney disease and the FDA allowing surrogate endpoints to now be used in rare kidney diseases, Processa is currently designing a new adaptive pivotal PCS499 Phase III study to discuss with the FDA later this year. In addition, Processa is establishing a dedicated subsidiary to hold PCS499. The move is intended to enhance strategic flexibility in targeting capital raising and potential partnership exploration after meeting with the FDA. PCS12852: As previously announced, Processa has signed a binding term sheet with Intact Therapeutics, Inc. granting an exclusive option to license PCS12852 for gastroparesis and related gastrointestinal motility disorders. Under the terms, Processa is eligible for up to $454 million in milestone payments, a 12% royalty on future sales, and a 3.5% equity stake in Intact. The partnership represents a strategic monetization of non-core assets while maintaining upside potential.PCS11T: PCS11T is Processa’s preclinical oncology asset based on the active metabolite of irinotecan. The company continues to define and explore preclinical and clinical development strategies as well as opportunities to support future development.PCS3117: After determining that the time and cost required to advance PCS3117 to a meaningful milestone would be too high, Processa has terminated the license agreement for PCS3117 and returning the rights to the original licensor. Commitment to Shareholder Value These portfolio changes align with Processa’s strategic intent to focus on oncology assets with strong differentiation, scientific rationale, commercial opportunity and clear regulatory pathways. The company believes this will optimize our human and capital resources, expedite the unlocking of hidden asset value through partnerships, and position the organization to deliver long-term shareholder returns. Investor Webinar Processa CEO George Ng will participate in a live investor webinar on Wednesday, July 9, 2025, at 4:15 p.m. ET to discuss the company’s strategic pipeline realignment and value-creating milestones. To register for the free webinar, please visit: https://www.redchip.com/webinar/PCSA/85765532754 Questions can be pre-submitted to PCSA@redchip.com or online during the live event. About Processa Pharmaceuticals, Inc. Processa is a clinical-stage pharmaceutical company focused on developing the Next Generation Cancer (NGC) drugs with improved safety and efficacy. Processa’s NGC drugs are modifications of existing FDA-approved oncology therapies resulting in an alteration of the metabolism and/or distribution of these drugs while maintaining the existing mechanisms of killing the cancer cells. By combining its novel oncology pipeline with proven cancer-killing active molecules and its Regulatory Science Approach, Processa’s strategy is to develop more effective therapy options with improved tolerability for cancer patients through an efficient regulatory path. In addition to its core oncology programs, Processa is actively pursuing strategic partnerships for non-oncology assets to unlock additional value For more information, visit our website at www.processapharma.com. Forward-Looking Statements This release contains forward-looking statements. The statements in this press release that are not purely historical are forward-looking statements which involve risks and uncertainties. Actual future performance outcomes and results may differ materially from those expressed in forward-looking statements. Please refer to the documents filed by Processa Pharmaceuticals with the SEC, specifically the most recent reports on Forms 10-K and 10-Q, which identify important risk factors which could cause actual results to differ from those contained in the forward-looking statements. Company Contact:Patrick Lin(925) 683-3218plin@processapharma.com Investor Relations:Dave GentryRedChip Companies, Inc.1-407-644-4256PCSA@redchip.com

License out/inPhase 2Phase 3

100 Deals associated with Irinotecan Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D01061	Irinotecan Hydrochloride	L01XX19	DBSALT000103

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Childhood Malignant Solid Neoplasm	Japan	Yakult Honsha Co., Ltd.	25 Mar 2013
Childhood Malignant Solid Neoplasm	Japan	Daiichi Sankyo Co., Ltd.	25 Mar 2013
Intestinal Neoplasms	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Jan 1998
Colonic Cancer	United States	Pfizer Inc.	14 Jun 1996
Rectal Cancer	United States	Pfizer Inc.	14 Jun 1996
Breast Cancer	Japan	Yakult Honsha Co., Ltd.	29 Sep 1995
Breast Cancer	Japan	Alfresa Pharma Corp.	29 Sep 1995
Breast Cancer	Japan	Daiichi Sankyo Co., Ltd.	29 Sep 1995
Colorectal Cancer	Japan	Daiichi Sankyo Co., Ltd.	29 Sep 1995
Colorectal Cancer	Japan	Yakult Honsha Co., Ltd.	29 Sep 1995
Colorectal Cancer	Japan	Alfresa Pharma Corp.	29 Sep 1995
Lymphoma	Japan	Alfresa Pharma Corp.	29 Sep 1995
Non-Hodgkin Lymphoma	Japan	Alfresa Pharma Corp.	29 Sep 1995
Non-Hodgkin Lymphoma	Japan	Daiichi Sankyo Co., Ltd.	29 Sep 1995
Non-Hodgkin Lymphoma	Japan	Yakult Honsha Co., Ltd.	29 Sep 1995
Squamous Cell Carcinoma	Japan	Daiichi Sankyo Co., Ltd.	29 Sep 1995
Squamous Cell Carcinoma	Japan	Alfresa Pharma Corp.	29 Sep 1995
Squamous Cell Carcinoma	Japan	Yakult Honsha Co., Ltd.	29 Sep 1995
Stomach Cancer	Japan	Alfresa Pharma Corp.	29 Sep 1995
Stomach Cancer	Japan	Daiichi Sankyo Co., Ltd.	29 Sep 1995

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
RAS Wild Type Colorectal Cancer	Phase 3	France	Hoffmann-La Roche, Inc.	30 Oct 2013
RAS Wild Type Colorectal Cancer	Phase 3	Ireland	Hoffmann-La Roche, Inc.	30 Oct 2013
RAS Wild Type Colorectal Cancer	Phase 3	Israel	Hoffmann-La Roche, Inc.	30 Oct 2013
Esophageal Carcinoma	Phase 3	Canada	Pfizer Inc.	01 Apr 2009
Colorectal Liver Metastases	Phase 3	France	Sanofi	01 Apr 2004
Colorectal Liver Metastases	Phase 3	France	Chugai Pharmaceutical Co., Ltd.	01 Apr 2004
Colorectal Liver Metastases	Phase 3	France	Pfizer Inc.	01 Apr 2004
Liver metastases	Phase 3	France	Chugai Pharmaceutical Co., Ltd.	01 Apr 2004
Liver metastases	Phase 3	France	Sanofi	01 Apr 2004
Liver metastases	Phase 3	France	Pfizer Inc.	01 Apr 2004

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03829462 (NEXT-REGIRI, CTgov)	Phase 3	Metastatic Colorectal Carcinoma	377	Regorafenib+Irinotecan (Irinotecan + Regorafenib (REGIRI))	apbhrkiswn(blpduxawbv) = ihegbmbodn iawnqvufwa (uietdcdsun, qtrxdrcjzc - cjiilkjpim) View more	-	18 Jul 2025
				Regorafenib (Regorafenib)	apbhrkiswn(blpduxawbv) = ukvvoqpznf iawnqvufwa (uietdcdsun, wudyxjyxuc - ycntbabbwr) View more
ESMO_GI2025	Not Applicable	Metastatic Colorectal Carcinoma	35	Bevacizumab, Oxaliplatin, Irinotecan (BOI) Therapy	liaebccspb(bvocbjtlmg) = 9 cases, 25.7% rxyrdtqxhl (qbwqikumpo ) View more	Positive	03 Jul 2025
NCT04554836 (CTgov)	Phase 2	Rectal Adenocarcinoma \| RAS mutant Colorectal Cancer \| Colonic Cancer	6	Cetuximab+Leucovorin Calcium+Irinotecan Hydrochloride+Fluorouracil (FOLFIRI + Cetuximab)	vlofflfiqb = mxgrjedjxa lpzvnalzwx (fxxnjdzkpg, pabmfozffq - fcyvfelwzo) View more	-	08 Jun 2025
				Leucovorin Calcium+Irinotecan Hydrochloride+Fluorouracil (FOLFIRI)	vlofflfiqb = wxbedpgmcp lpzvnalzwx (fxxnjdzkpg, dgogbhzwnr - khtocltlcg) View more
NCT04059562 (TRITICC, ASCO2025) Manual	Phase 2	Bile Duct Neoplasms Second line	28	Trifluridine/tipiracil + Irinotecan	etvaujkulw(izngsswxts) = mliygdtnic gjuvkuvvpq (hgvmanuqmd, 2.0 - 7.5) View more	Positive	30 May 2025
LITTORAL study (ASCO2025)	Not Applicable	Mouth Neoplasms	182	ONCORAL (Patients with sufficient HL score)	fsjemnxoci(xitdfvvmlt) = aobqonmwll dxozqrtxsz (vducnizmtb )	Positive	30 May 2025
ASCO2025	Phase 2	High Risk Neuroblastoma	34	HITS (Irinotecan, Temozolomide, Naxitamab, GM-CSF)	osxjyputmc(ilvvudurny) = sqvbkkxmby lxmqhhyznh (zcumfsdyhc ) View more	Positive	30 May 2025
				NICE (Naxitamab, GM-CSF, Ifosfamide, Carboplatin, Etoposide)	osxjyputmc(ilvvudurny) = xqnciqqcio lxmqhhyznh (zcumfsdyhc ) View more
NCT04625907 (FaR-RMS, ASCO2025)	Phase 1	Rhabdomyosarcoma FOXO1 fusion-positive	22	Irinotecan 50 mg/m²/day	qhhvkkwfia(cdabwhwoeg) = 45.5% khodkdbvfi (yfbdoaekiv ) View more	Positive	30 May 2025
NCT00545545 (CTgov)	Phase 1/2	Colorectal cancer recurrent \| Colorectal Cancer	32	PGG+Cetuximab+Irinotecan (Arm 1, Imprime PGG Injection 2 mg/kg+ Cetuximab + Irinotecan)	gjkghzhzoa = fgawqipkme ycqfjopnhf (vqirfqbejn, kgmvvylbld - jelmycdpey) View more	-	19 Mar 2025
				PGG+Cetuximab+Irinotecan (Arm 1, Imprime PGG Injection 4 mg/kg+ Cetuximab + Irinotecan)	gjkghzhzoa = fxeqlzqveg ycqfjopnhf (vqirfqbejn, mgyensxboj - fwqtmefnnr) View more
NCT04380337 (SHORT-FOX, CTgov)	Phase 2	Rectal Cancer \| Rectal Adenocarcinoma	38	IMRT+LEUCOVORIN CALCIUM+irinotecan+oxaliplatin+capecitabine+Fluorouracil	woeaxoliuf = bcdbaadvhe vesnmhvnnv (lorpqruumz, wdgxiplcju - zymjlgzytr) View more	-	25 Feb 2025
NCT05229003 (ZL-IRIAN, ASCO_GI2025)	Phase 2	Metastatic Colorectal Carcinoma Second line pMMR \| MSS	23	Anlotinib 10mg daily + Irinotecan 180mg/m	ndpmeavbjr(iinrjvdccn) = dgcsbtsdis mlgchuwkgd (zoskoymtrl, 9.43 - 34.03) View more	Positive	23 Jan 2025
				Anlotinib 8mg daily + Irinotecan 180mg/m + Penpulimab 200mg	ndpmeavbjr(iinrjvdccn) = toqxnooxga mlgchuwkgd (zoskoymtrl, 11.44 - 26.90) View more

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