[{"orgOrder":0,"company":"Cancer Prevention Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Cancer Prevention Pharmaceuticals Submits EU Marketing Authorization Application for CPP-1X\/sul to Treat Familial Adenomatous Polyposis","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Cancer Prevention Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Cancer Prevention Pharmaceuticals Submits New Drug Application to the FDA for CPP-1X\/sul for Treatment of Familial Adenomatous Polyposis","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Orbus Therapeutics","sponsor":"Longitude Capital","pharmaFlowCategory":"D","amount":"$71.0 million","upfrontCash":"Undisclosed","newsHeadline":"Orbus Therapeutics Expands Series A Financing to $71 Million to Support Ongoing STELLAR Phase 3 Study in Rare Brain Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Cancer Prevention Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Cancer Prevention Pharmaceuticals Publishes Landmark Phase 3 Clinical Trial Data for Treatment of Familial Adenomatous Polyposis in NEJM","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"US WorldMeds","sponsor":"Norgine","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Norgine Enter Agreement to Commercialise DFMO in Independent States","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Orbus Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Orbus Therapeutics Receives U.S. Patent for Eflornithine Formulations","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Cancer Prevention Pharmaceuticals","sponsor":"Panbela Therapeutics","pharmaFlowCategory":"D","amount":"$60.0 million","upfrontCash":"Undisclosed","newsHeadline":"Panbela Therapeutics, Inc. to Acquire Cancer Prevention Pharmaceuticals, Inc.","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Cancer Prevention Pharmaceuticals","sponsor":"Panbela Therapeutics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Panbela Therapeutics, Inc. Closes Acquisition of Cancer Prevention Pharmaceuticals, Inc.","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Orbus Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Orbus Therapeutics Granted European Patent for Method of Use for Eflornithine","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Orbus Therapeutics","sponsor":"Michigan State University","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Orbus Therapeutics Enters Exclusive License Agreement for Intellectual Property Related to Treatment of Rare Pediatric Syndrome with Eflornithine","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Undisclosed","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Undisclosed"},{"orgOrder":0,"company":"Panbela Therapeutics","sponsor":"Indiana University School of Medicine","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Panbela Starts Phase II Trial of CPP-1X-T for Recent Onset Type I Diabetes, in Collaboration with Indiana University School of Medicine and JDRF","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase I"},{"orgOrder":0,"company":"Panbela Therapeutics","sponsor":"Johns Hopkins University School of Medicine","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Panbela Announces New Research Agreement with Johns Hopkins University School of Medicine","therapeuticArea":"Oncology","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Preclinical"},{"orgOrder":0,"company":"Orbus Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Orbus Therapeutics\u2019 Phase 3 Eflornithine STELLAR Study Reaches Full Patient Enrollment","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Panbela Therapeutics","sponsor":"One-Two Therapeutics Assets Limited","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Panbela Regains Worldwide Rights to Develop and Commercialize FlynpoviTM in Patients with Familial Adenomatous Polyposis (FAP)","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Panbela Therapeutics","sponsor":"Moffitt Cancer Center","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Panbela Announces Clinical Trial with Moffitt Cancer Center for Phase I\/II Program in STK11 Mutant Non-Small Cell Lung Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Panbela Therapeutics","sponsor":"US WorldMeds","pharmaFlowCategory":"D","amount":"$9.5 million","upfrontCash":"Undisclosed","newsHeadline":"Panbela Therapeutics to Receive a Total Up to $9.5 Million for Divestiture of Assets within Eflornithine (DFMO) Pediatric Neuroblastoma Program to US WorldMeds","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Panbela Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Panbela to Participate in the Roth Inaugural Healthcare Opportunities Conference","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Panbela Therapeutics","sponsor":"JDRF","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"First Patient Enrolled in JDRF-Funded Phase II Trial of CPP-1X-T for Recent Onset Type I Diabetes, Led by Indiana University School of Medicine","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2023","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase II"},{"orgOrder":0,"company":"Orbus Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Orbus Therapeutics Announces First Patient Enrolled in Phase 1 Clinical Study in Newly Diagnosed Glioblastoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"US WorldMeds","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"US WorldMeds Announces FDA Approval of IWILFIN\u2122 (eflornithine) to Strengthen Fight Against Aggressive Childhood Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"US WorldMeds","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Approves Eflornithine for Adult and Pediatric Patients with High-Risk Neuroblastoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Panbela Therapeutics","sponsor":"US WorldMeds","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Panbela Therapeutics Announces US WorldMeds NDA Approval for Eflornithine (DFMO) in Pediatric Neuroblastoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Norgine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Norgine B.V. Submits Marketing Authorisation Application via Project Orbis for Eflornithine (difluoromethylornithine [DFMO]) in High-risk Neuroblastoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"NETHERLANDS","productType":"Small molecule","productStatus":"Approved","date":"April 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals for Eflornithine Hydrochloride
Iwilfin (eflornithine) is a USFDA approved ornithine decarboxylase inhibitor indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma.
CPP-1X-T (eflornithine) is a single agent tablet or high dose powder sachet for several indications including prevention of gastric cancer, treatment of neuroblastoma and recent onset type 1 diabetes. It is approved by USFDA for the treatment of Pediatric Neuroblastoma.
Iwilfin (eflornithine) is an ornithine decarboxylase inhibitor used to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB).
Iwilfin (eflornithine) is an ornithine decarboxylase inhibitor used to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB).
DFMO (eflornithine) is a novel cytostatic agent that irreversibly inhibits ornithine decarboxylase, which is investigated in combination with eflornithine in patients newly diagnosed with glioblastoma.
Panbela has divested certain assets in its eflornithine pediatric neuroblastoma program including, CPP-1X (eflornithine), being developed for several indications including prevention of gastric cancer, treatment of neuroblastoma and recent onset Type 1 diabetes.
The agreement is for a Phase I/II program in STK11 mutant non-small cell lung cancer (NSCLC). The initial goal of the Phase I trial is evaluating the maximum tolerated dose of CPP-1X (eflornithine).
CPP-1X-T (eflornithine) is being developed as a single agent tablet or high dose power sachet for several indications including prevention of gastric cancer, treatment of neuroblastoma and recent onset type 1 diabetes.
Panbela has regained the North American rights to develop and commercialize Flynpovi (the combination of CPP-1X (eflornithine hydrochloride) and sulindac) in patients with FAP. The drug is withdrawn form the european market and company will conduct FAP trial for phase 3.
The collaboration is intended to expand the development of Panbela’s investigative agent SBP-101 (ivospemin), including activity in models of ovarian and other cancer types, further evaluations into MOA, and potential combination with CPP-1X and standard of care agents.