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Last update 08 May 2025

Eflornithine Hydrochloride

Last update 08 May 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

(RS)-2,5-diamino-2-(difluoromethyl)pentanoic acid, 2-(difluoromethyl)ornithine, DFMO

+ [18]

Target-

Action-

Mechanism-

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal DiseasesOther Diseases+ [8]

Active Indication

High Risk NeuroblastomaHirsutismAdenomatous Polyposis Coli+ [11]

Inactive Indication

Facial HypertrichosisNeuroblastoma recurrent

Originator Organization

Sanofi

Active Organization

Panbela Therapeutics, Inc.

Cancer Prevention Pharmaceuticals, Inc.Norgine Pty Ltd.

+ [5]

Inactive Organization

AbbVie, Inc.

Indiana University

Sanofi-Aventis U.S. LLC

License Organization

Michigan State University

MDD US Operations LLC

Orbus Therapeutics, Inc.

+ [2]

Drug Highest PhaseApproved

First Approval Date

United States (28 Nov 1990),

Facial Hypertrichosis

RegulationOrphan Drug (European Union)

Structure/Sequence

Molecular FormulaC6H12F2N2O2

InChIKeyVLCYCQAOQCDTCN-UHFFFAOYSA-N

CAS Registry70052-12-9

View All Structures (2)

Clinical Trials associated with Eflornithine Hydrochloride

NCT06465199

/ Not yet recruitingPhase 1/2IIT

A Dose Escalation Study Using Difluoromethylornithine (DFMO) and AMXT-1501 Followed by a Randomized Controlled Trial of DFMO With or Without AMXT-1501 for Neuroblastoma, CNS Tumors, and Sarcomas

The purpose of this study is to evaluate the investigational drug AMXT 1501 (a pill taken by mouth) in combination with the drug difluoromethylornithine (DFMO) for infusion administered intravenously (IV; a liquid that continuously goes into your body through a tube that has been placed during a surgery into one of your veins). An investigational drug is one that has not been approved by the U.S. Food & Drug Administration (FDA), or any other regulatory authorities around the world for use alone or in combination with any drug, for the condition or illness it is being used to treat.
The goals of this part of the study are:
* Establish a recommended dose of AMXT 1501 in combination with DFMO for infusion
* Test the safety and tolerability of AMXT 1501 in combination with DFMO for infusion in patients with cancer
* To determine the activity of study treatments chosen based on:
* How each subject responds to the study treatment
* How long a subject lives without their disease returning/progressing

Start Date01 Oct 2025

Sponsor / Collaborator

Hershey Medical Center

[+1]

NCT06219174

/ RecruitingPhase 1/2IIT

Targeting ODC as an Immunotherapeutic Target in STK11 (LKB1) Pathway-Deficient NSCLC

The purpose of this study is to establish the safety, toxicity, and tolerability of Difluoromethylornithine (DFMO) in combination with pembrolizumab in advanced/metastatic Non-Small Cell Lung Cancer (NSCLC). Researchers also want to investigate how effective DFMO is at treating patients with advanced/ metastatic NSCLC.

Start Date07 Aug 2024

Sponsor / Collaborator

H. Lee Moffitt Cancer Center & Research Institute, Inc.

NCT06059118

/ RecruitingPhase 2IIT

Repeat Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Asymptomatic Patients With Metastatic Castration-Resistant Prostate Cancer: The APEX (Androgen and Polyamine Elimination Alternating With Xtandi) Trial

Asymptomatic patients with metastatic castrate resistant prostate cancer (mCRPC) without pain due to prostate cancer will be treated on an open label study to evaluate effectiveness of sequential treatment with the combination of difluoromethylornithine (DFMO) and high dose testosterone in sequence with enzalutamide to improve primary and secondary outcomes.

Start Date04 Oct 2023

Sponsor / Collaborator

The Sidney Kimmel Comprehensive Cancer Center

[+3]

100 Clinical Results associated with Eflornithine Hydrochloride

100 Translational Medicine associated with Eflornithine Hydrochloride

100 Patents (Medical) associated with Eflornithine Hydrochloride

3,343

Literatures (Medical) associated with Eflornithine Hydrochloride

15 Jun 2025·International Journal of Cancer

Polyamine depletion limits progression of acute leukaemia

Article

Author: Norris, Murray D. ; Verhelst, Steven H. L. ; Gao, Weiman ; Burns, Mark R. ; Tanaka, Katsunori ; Haber, Michelle ; Karsa, Ayu ; Mayoh, Chelsea ; Somers, Klaartje ; Lock, Richard B. ; Spurling, Dayna ; Xiao, Lin ; Kotecha, Rishi S. ; Azfar, Mujahid ; Cheung, Laurence C. ; Vangheluwe, Peter ; Bongers, Angelika ; Guo, Xinyi ; Karsa, Mawar ; Ronca, Emma

AbstractCancer cells are addicted to polyamines, polycations essential for cellular function. While dual targeting of cellular polyamine biosynthesis and polyamine uptake is under clinical investigation in solid cancers, preclinical and clinical studies into its potential in haematological malignancies are lacking. Here we investigated the preclinical efficacy of polyamine depletion in acute leukaemia. The polyamine biosynthesis inhibitor difluoromethylornithine (DFMO) inhibited growth of a molecularly diverse panel of acute leukaemia cell lines, while non‐malignant cells were unaffected. Responsiveness to DFMO was linked to decreased levels of its molecular target, the rate‐limiting polyamine biosynthesis enzyme ODC1, and of the polyamine transporters ATP13A2 and ATP13A3. DFMO increased polyamine uptake and upregulated expression of polyamine transporters in acute leukaemia cells, a compensatory effect abolished by treatment with the polyamine transport inhibitor AMXT 1501. This drug, currently in a phase 1 clinical trial in solid tumours in combination with DFMO, potentiated the inhibitory effects of DFMO, and their combination synergistically inhibited the growth of acute leukaemia cell lines by inducing apoptosis. DFMO and AMXT 1501 limited disease progression in highly aggressive xenograft models of infant KMT2A‐rearranged leukaemia, even when treatment was initiated at high disease burden. Increased expression of c‐MYC was associated with enhanced sensitivity to the combination of DFMO and AMXT 1501, suggesting this oncoprotein as a potential predictive marker of response to the drug combination. In conclusion, targeting polyamine biosynthesis and polyamine uptake limits disease progression in models of acute leukaemia, supporting further preclinical and clinical investigation into this approach for acute leukaemia.

18 Mar 2025·Cureus

Lateral Displacement Calcaneal Osteotomy Combined With Anterolateral Transfer of the Tibialis Posterior Tendon for Treating Flexible Cavovarus Foot in an Adult Patient: A Case Report

Article

Author: Moriwaki, Dan ; Nakasa, Tomoyuki ; Adachi, Nobuo ; Kawabata, Shingo ; Ikuta, Yasunari

The cavovarus foot is a spectrum of foot deformity primarily caused by muscular imbalance and characterized by increased pitch, varus of the hindfoot, plantar flexion of the midfoot, and pronation and adduction of the forefoot. Surgery for cavovarus foot commonly involves some combination of procedures, however, no consensus has emerged regarding their choice. We report the case of a 68-year-old male with a flexible cavovarus foot. The patient complained of pain in the subtalar joint and plantar callosities. For this patient, we performed lateral displacement calcaneal osteotomy (LDCO), anterolateral transfer of the tibialis posterior tendon (TPT), and dorsiflexion first metatarsal osteotomy (DFMO). At one year and nine months after surgery, plain radiographs revealed bony union at the osteotomy sites of the calcaneus and first metatarsal. The Japanese Society for Surgery of the Foot hindfoot scale and visual analogue scale improved from 52 points preoperatively to 82 points at the final follow-up and from 3 points to 1 point, respectively. A combination of LDCO, TPT, and DFMO is effective for adult patients with flexible cavovarus foot.

13 Mar 2025·Clinical Microbiology Reviews

Transforming the chemotherapy of human African trypanosomiasis

Review

Author: Barrett, Michael P.

SUMMARY Prior to 2019, when the orally available drug fexinidazole began its clinical use, the treatment of human African trypanosomiasis (HAT) was complex and unsatisfactory for many reasons. Two sub-species of the Trypanosoma brucei parasite are responsible for HAT, namely the rhodesiense form found in East and Southern Africa and the gambiense form found in Central and West Africa. Diseases caused by both forms manifest in two stages: stage 1 before and stage 2 after central nervous system involvement. Prior to 2019, different drugs were required for each of the two parasite sub-species at each stage. Gambiense disease required pentamidine or nifurtimox-eflornithine combination therapy, while for rhodesiense disease, suramin or melarsoprol was given for stages 1 and 2, respectively. These drugs all suffered complications including protracted administration regimens involving multiple injections with drug-induced adverse effects common. Today, a single drug, fexinidazole, can be given orally in most cases for both diseases at either stage. Another compound, acoziborole, effective in both stages 1 and 2 gambiense disease with a single dosing is anticipated to become available within a few years. Moreover, the recent engagement of multilateral organizations in seeking other compounds that could be used in HAT therapy has also been successful, and a rich vein of new trypanocides has been discovered. Here, the clinical use, modes of action, and resistance risks for drugs used against HAT are discussed.

122

News (Medical) associated with Eflornithine Hydrochloride

17 Apr 2025

·www.prnewswire.com

Norgine welcomes TGA registration in Australia of IFINWIL® (eflornithine) for adults and children diagnosed with high-risk neuroblastoma (HRNB)[1]

IFINWIL®: now TGA registered in Australia Children diagnosed with neuroblastoma are on average just 2 years old2 The average survival rate of children with HRNB is only 50%2 UXBRIDGE, England, April 17, 2025 /PRNewswire/ -- Norgine is pleased to announce that the Australian Therapeutic Goods Administration (TGA) has approved the registration of IFINWIL® (eflornithine) for the treatment of adults and paediatric patients with high-risk neuroblastoma (HRNB), who have responded to prior multiagent, multimodality therapy.1 Neuroblastoma Australia welcomed the news today: "On behalf of all families of children impacted by neuroblastoma, we welcome the TGA's decision to approve IFINWIL®. We urgently need treatments for children diagnosed with neuroblastoma and this milestone marks a step in the right direction towards a better future for children and their families. We thank the Federal Government for taking action to ensure access and we look forward to continued support for children with aggressive cancers." said Lucy Jones, CEO Neuroblastoma Australia. High Risk Neuroblastoma is a rare but aggressive form of cancer, predominantly affecting children and most commonly presenting in the first 5 years of life2. Each year in Australia, approximately 50 children are diagnosed with neuroblastoma, with about half of these cases being classified as high risk neuroblastoma3,4. Neuroblastoma originates in the body's nerve cells (neuroblasts) and typically presents as a primary tumour in the adrenal glands5. It is considered an aggressive tumour because it often spreads to other parts of the body (metastasizes). In most cases, it has spread by the time it is diagnosed5. "We are committed to improving the lives of children and their families living with high-risk neuroblastoma" said Gus Rudolph, General Manager, Norgine, Australia. "This rare childhood cancer has devastating consequences for those impacted and while more needs to be done to improve treatment outcomes, we would like to recognise the TGA for their work to-date on this approval. Norgine will continue to engage with the relevant stakeholders to bring IFINWIL® to patients as quickly as possible." "This approval, as part of the Project Orbis initiative, represents a vital step forward in ensuring access to innovative cancer treatments for patients around the world," said Dr. David Gillen, Chief Medical Officer, Norgine. "By working collaboratively with international regulatory partners, we are able to help bring promising therapies to paediatric patients sooner – a goal that is especially important when time is critical. We're proud to support Project Orbis as we strive to expedite access to high-impact oncology medicines." Receiving the TGA approval is an important milestone on the path to realising sustainable and equitable access. IFINWIL® is not currently included on the PBS. Please refer to the IFINWIL® Consumer Medicines Information (CMI) for full safety information on risks, side effects and precautions including the risk of low red blood cells (anaemia), low neutrophils (blood cells that fight infection), low platelets (clotting cells), increase in liver enzymes, and hearing loss or problems balancing.1 Notes to Editors: About IFINWIL® IFINWIL® has been investigated for use as a post maintenance treatment for high-risk neuroblastoma (HRNB) in paediatric patients with no active disease (NAD) / no evidence of disease (NED) after first line multiagent, multimodality therapy.6 IFINWIL® is a therapy that blocks an enzyme called ornithine decarboxylase (ODC) responsible for producing polyamines, which are important to tumour growth and development 7. For more information on IFINWIL®, find the CMI here: IFINWIL Consumer Medicine Information (CMI) or the Therapeutic Goods Administration at or speak to your healthcare practitioner. High-Risk Neuroblastoma (HRNB) Treatment Background Children diagnosed with HRNB undergo an intense treatment regimen that still leaves them vulnerable to relapse and death.8 Although there have been some improvements in survival, children with high risk neuroblastoma still face a 30% chance of recurrence (relapse) within the first 5 years post maintenance, and have an extremely poor prognosis and low likelihood of long term survival9 (e.g. estimates as low as 15% of patients will live for five years after relapsing).10 Avoiding relapse is key to long-term survival, and until now, there have been no approved therapies for the post maintenance treatment period in major markets outside of the United States11. About Project Orbis Project Orbis is an initiative (since May 2019) of the US FDA Oncology Center of Excellence (OCE) and provides a framework for concurrent submission and collaborative review of innovative oncology products among international regulatory authorities. It was created with the overarching goal to speed worldwide patient access to innovative cancer therapies. Project Orbis is coordinated by the FDA, and its partners include United Kingdom Medicines and Healthcare Products regulatory Agency (UK MHRA), Australia Therapeutic Goods Administration (TGA), Canada (Health Canada), Singapore (Health Sciences Authority (HSA), Switzerland (Swissmedic), Brazil (Agência Nacional de Vigilância Sanitária (ANVISA), Israel (Ministry of Health). In April 2024, Norgine submitted an application for approval of eflornithine in high-risk neuroblastoma (HRNB), via Project Orbis in Australia, Switzerland and the United Kingdom. This milestone supports Norgine's efforts to deliver patient access to eflornithine and bring a further treatment option in the field of paediatric oncology. About Norgine Norgine is a leading European specialist pharmaceutical company that has been bringing transformative medicines to patients for over a century. Our commitment to transforming people's lives drives everything we do, and our European experience, fully integrated infrastructure and exceptional partnership approach enable us to quickly apply creative solutions to bring life-changing medicines to patients that they may not otherwise be able to access. Norgine is proud to have helped more than 25 million patients around the world in 2022 and generated €530 million in net product sales, a growth of nearly 5% over 2021. Norgine has a direct presence in 16 European countries, as well as Australia and New Zealand. We also have a strong global network of partnerships in non-Norgine markets. We are a flexible and fully integrated pharmaceutical business, with manufacturing (Hengoed, Wales and Dreux, France), third party supply networks and significant product development capabilities, in addition to our sales and marketing infrastructure. This enables us to acquire, develop and commercialise specialist and innovative products that make a real difference to the lives of patients around the world. NORGINE and the sail logo are trademarks of the Norgine group of companies. References Australian Product Information, IFINWIL®: IFINWIL Product Information (PI). Accessed 16.04.25 . Accessed 26.03.25 Australian Childhood Cancer Registry, Cancer Council Queensland. Australian Childhood Cancer Statistics Online (1983-2021). CCQ: Brisbane, Australia; October 2024. ANZCHOG-Position-Statement-Eflornithine-DFMO-use-for-patients-with-high-risk-neuroblastoma-in-Australia-and-New-Zealand-v2.0-23.08.2024.pdf . Accessed 16.03.25 Clinical Trial NCT02395666; Preventative trial of difluoromethylornithine (DFMO) in high risk patients with neuroblastoma that is in remission. Available from: Study Details | Preventative Trial of Difluoromethylornithine (DFMO) in High Risk Patients With Neuroblastoma That is in Remission | ClinicalTrials.gov. Meyskens FL Jr, Gerner EW. Clin Cancer Res. 1999 May;5(5):945-51. 4. Sholler GLS, et al. Sci Rep. 2018 Sep 27;8(1):14445. Basta NO, Halliday GC, Makin G, Birch J, Feltbower R, Bown N, et al. Factors associated with recurrence and survival length following relapse in patients with neuroblastoma. Br J Cancer. 2016;115:1048-57. Desai A, et al. J Clin Oncol. 2022 Jul; JCO2102478. 2. Lewis EC, et al. Int J Cancer. 2020 Dec;147(11):3152-3159 Bagatell R, DuBois SG, Naranjo A, et al. Children's Oncology Group's 2023 blueprint London WB, Bagatell R, Weigel BJ, Fox E, Guo D, Van Ryn C, et al. Historical time to disease progression and progression-free survival in patients with recurrent/refractory neuroblastoma treated in the modern era on Children's Oncology Group early-phase trials. Cancer. 2017;123:4914-23. FDA approves eflornithine for adult and pediatric patients with high-risk neuroblastoma | FDA FDA approves eflornithine for adult and pediatric patients with high-risk neuroblastoma | FDA, Accessed 02.04.25 Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalAccelerated Approval

15 Apr 2025

·www.prnewswire.com

Norgine strengthens rare disease portfolio with acquisition of Theravia

Acquisition of Theravia from Mérieux Equity Partners represents meaningful step forward in Norgine's strategy for sustainable growth, adding a complementary portfolio of rare disease medicines. Transaction further establishes Norgine's position as a partner of choice for commercialising rare and specialty pharmaceuticals in Europe. PARIS, April 15, 2025 /PRNewswire/ -- Norgine and Theravia announced today that they have entered into a definitive agreement under which Norgine will acquire Theravia, an international pharmaceutical company specialising in cutting-edge treatments for patients with rare and debilitating conditions. Recent deals with Fennec Pharma for PEDMARQSI® and X4 Pharma for mavorixafor demonstrate Norgine's strong emphasis on driving growth in rare disease and specialty medicines through acquisitions and in-licensing. Theravia's innovations have resulted in successful launches of life-saving medications which have changed patient outcomes worldwide. Theravia has several products in the rare disease space, including SIKLOS®, for adults and children with sickle cell disease, and ORPHACOL®, a medicine for adults and children who have a genetic disorder that affects bile production by the liver. These products span both the rare haematology and rare hepatology therapeutic areas and are complementary to Norgine's existing rare and specialty portfolio. The development of Theravia in the past few years has been supported by its majority shareholder Mérieux Equity Partners, a healthcare dedicated investment firm based in France. said Janneke van der Kamp, Chief Executive Officer, Norgine. Franck Hamalian, Chief Executive Officer, Theravia, added: With the acquisition of Theravia, Norgine will now have six core products in its rare disease portfolio (PEDMARQSI®, eflornithine, mavorixafor, AGILUS®, SIKLOS® and ORPHACOL®) thereby comprising a franchise of critical scale with the ability to be a key growth driver in the medium-to-long-term. Norgine looks forward to building on this transaction as we continue to strengthen our platform for future acquisitions and in-licensing opportunities to drive growth. The transaction remains subject to obtaining customary regulatory approvals from the competent authorities.

Drug ApprovalAcquisitionOrphan DrugPhase 3

07 Jan 2025

·www.prnewswire.com

Norgine submits Marketing Authorisation Application to the European Medicines Agency for eflornithine (difluoromethylornithine [DFMO]) in high-risk neuroblastoma

Back to media releases Next media release LONDON, Jan. 7, 2025 /PRNewswire/ -- Norgine today announced that it completed its marketing authorisation application filing to European Medicines Agency (EMA) for eflornithine in high-risk neuroblastoma (HRNB). This follows the submissions in April 2024, via Project Orbis, in Australia, Switzerland and the United Kingdom. This milestone further supports Norgine's efforts to give patients access to eflornithine and bring a further treatment option in the field of paediatric oncology. Norgine and USWM, LLC (dba US WorldMeds), a Kentucky-based specialty pharmaceutical company, have an exclusive licensing agreement by which Norgine will register and commercialise eflornithine, also referred to as DFMO, in Europe, Australia and New Zealand. On 13 December 2023, the US Food and Drug Administration (FDA) approved eflornithine as the first oral maintenance therapy for HRNB, indicated to reduce the risk of relapse in adult and paediatric patients who have received certain prior therapies.[1] The approval decision was based on findings from a trial comparing outcomes from patients treated with eflornithine in Study 3b (NCT02395666)[2],[4] to control patients derived from Study ANBL0032 (NCT00026312; clinical-trial-derived external control arm)[3],[4]. The study with eflornithine treated patients showed improved event-free survival and overall survival when compared to outcomes for patients with HRNB treated with the standard of care (SoC).[1] Dr David Gillen, Chief Medical Officer at Norgine, added, "This submission via the EU Centralised Procedure represents another important step in the regulatory process for eflornithine and further emphasises Norgine's passion and commitment in attempting to secure additional treatment options for patients living with HRNB, a condition with a high level of unmet medical need." Janneke van der Kamp, CEO of Norgine added "Submitting this marketing authorisation to the EMA marks a pivotal step for patients facing this challenging cancer. We are committed to advancing innovative therapies that address the unmet needs of young patients and their families, and this milestone brings us closer to offering hope where it's most needed". Follow @norgine Notes to Editors: HRNB background Children diagnosed with HRNB undergo an intense SoC regimen that still leaves them vulnerable to relapse and death, a risk that is highest for the first two years after completing treatment.[5] Approximately 30% of patients who attain remission following upfront therapy will relapse, and once relapsed, mortality significantly increases with a post-relapse 4-year overall survival of under 10%.[5], [6] Therefore, avoiding relapse is key to long-term survival, yet outside of the United States there are no approved therapies for sustaining remission following SoC treatment. The data demonstrate that using eflornithine after completion of upfront SoC treatment, as post-maintenance therapy extends remission and reduces risk of relapse in patients with HRNB. About Norgine Norgine is a uniquely positioned, specialty pharmaceutical and consumer healthcare company, with over €500 million of annual revenues and a 120-year track record of bringing life-changing products to patients and consumers across our core markets of Western Europe, Australia and New Zealand. Our integrated approach – strong commercial capabilities, deep medical, regulatory and clinical expertise, in-house manufacturing, robust supply networks, and best in class enabling functions – ensures that we can deliver high-quality, transformative medicines quickly and effectively to over 25 million patients annually. Today's Norgine is a nimble, innovative, and high-performing company that has been transformed by a relentless focus on operational excellence. This focus will enable us to secure the legacy of more than a century of innovation and doing the right thing by our patients, as we push the boundaries and take strides into new therapeutic areas. NORGINE and the sail logo are trademarks of the Norgine group of companies. References FDA approves eflornithine for adult and pediatric patients with high-risk neuroblastoma. FDA. News release. 13 December 2023. Available from: FDA approves eflornithine for adult and pediatric patients with high-risk neuroblastoma | FDA Clinical Trial NCT02395666; Preventative trial of difluoromethylornithine (DFMO) in high risk patients with neuroblastoma that is in remission. Available from: Study Details | Preventative Trial of Difluoromethylornithine (DFMO) in High Risk Patients With Neuroblastoma That is in Remission | ClinicalTrials.gov. Clinical Trial NCT00026312; Isotretinoin with or without dinutuximab,[1] aldesleukin, and sargramostim following stem cell transplant in treating patients with neuroblastoma. Available from: Study Details | Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma | ClinicalTrials.gov Oesterheld J, Ferguson W, Kraveka JM, Bergendahl G, Clinch T, Lorenzi E et al. Eflornithine as Postimmunotherapy Maintenance in High-Risk Neuroblastoma: Externally Controlled, Propensity Score-Matched Survival Outcome Comparisons. 2024; 42 (1): 90-102. Basta NO, Halliday GC, Makin G, Birch J, Feltbower R, Bown N, et al. Factors associated with recurrence and survival length following relapse in patients with neuroblastoma. Br J Cancer. 2016;115:1048-57. London WB, Bagatell R, Weigel BJ, Fox E, Guo D, Van Ryn C, et al. Historical time to disease progression and progression-free survival in patients with recurrent/refractory neuroblastoma treated in the modern era on Children's Oncology Group early-phase trials. Cancer. 2017;123:4914-23.[2] Job code: UK-ONC-NP-2400019 Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

License out/inDrug Approval

100 Deals associated with Eflornithine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	Eflornithine Hydrochloride	P01CX03 D11AX16	DB06243

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
High Risk Neuroblastoma	United States	MDD US Operations LLC	13 Dec 2023
Hirsutism	Norway	Almirall SA	19 Mar 2001
Hirsutism	Iceland	Almirall SA	19 Mar 2001
Hirsutism	Liechtenstein	Almirall SA	19 Mar 2001
Hirsutism	European Union	Almirall SA	19 Mar 2001

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
High Risk Neuroblastoma	NDA/BLA	United Kingdom	Norgine BV	10 Apr 2024
High Risk Neuroblastoma	NDA/BLA	Australia	Norgine BV	10 Apr 2024
High Risk Neuroblastoma	NDA/BLA	Switzerland	Norgine BV	10 Apr 2024
Adenomatous Polyposis Coli	Phase 3	United States	Cancer Prevention Pharmaceuticals, Inc.	23 Aug 2013
Second Primary Neoplasms	Phase 3	United States	Cancer Prevention Pharmaceuticals, Inc.	23 Aug 2013
Astrocytoma	Preclinical	France	Orbus Therapeutics, Inc.	01 Jul 2016
Astrocytoma	Preclinical	Germany	Orbus Therapeutics, Inc.	01 Jul 2016
Astrocytoma	Preclinical	Belgium	Orbus Therapeutics, Inc.	01 Jul 2016
Astrocytoma	Preclinical	Canada	Orbus Therapeutics, Inc.	01 Jul 2016

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02794428 (CTgov)	Phase 2	Carcinogenesis \| Gastritis, Hypertrophic \| Stomach Cancer	91	Eflornithine (Eflornithine)	qhrtveyvmz(virpyrowgn) = fbrtuaxrlc ygockvymir (rrpwwpfixl, wsmpgpyxvp - orgqzeesui) View more	-	05 Apr 2024
				Eflornithine placebo (Eflornithine Placebo)	qhrtveyvmz(virpyrowgn) = mvablrwkoh ygockvymir (rrpwwpfixl, tvvezvvter - tyenramsgh) View more
NCT03794349 (Literature \| Pubmed \| Br J Cancer) Manual	Phase 1	Neuroblastoma recurrent	24	DFMO+celecoxib+cyclophosphamide +topotecan	(lshwasoejf) = upphpappoi lqzcrtkimy (shlivjuhdy ) View more	Positive	10 Jan 2024
NCT02395666 (NMTRC003B, Pubmed \| J Clin Oncol)	Phase 2	High Risk Neuroblastoma Maintenance	141	Eflornithine (DFMO)	(guiohljrbi): HR = 0.5 (95% CI, 0.29 - 0.84)	Positive	01 Jan 2024
				No-DFMO/control group
NCT02395666 (ANBL0032, FDA) Manual	Phase 2	High Risk Neuroblastoma	360	IWILFIN	(ihardofrrm): HR = 0.48 (95% CI, 0.27 - 0.85) View more	Positive	13 Dec 2023
				control
NCT02395666 \| NCT00026312 (ASCO2022)	Phase 2	High Risk Neuroblastoma Maintenance	140	DFMO	(iqgwarokea): hazard ratio = 0.48 (95% CI, 0.27 - 0.85), P-Value = 0.0114 View more	Positive	02 Jun 2022
				eflornithine (DFMO) (Control)
NCT01483144 (Pubmed \| Dis Colon Rectum)	Phase 3	Adenomatous Polyposis Coli	158	Eflornithine	(mrqtekwkni) = kdofxhntrb eiekefvxml (wjjjfuamiz ) View more	-	12 Jul 2021
				Sulindac	(mrqtekwkni) = chhlsvovcs eiekefvxml (wjjjfuamiz ) View more
NCT01483144 (CTgov)	Phase 3	Adenomatous Polyposis Coli	171	Sulindac 150 MG+Eflornithine (Eflornithine Plus Sulindac)	rgqrabiapt(dkkimczjjb) = uhhccuhflk uwfzdbuhzo (uwzssyodpu, adnifcrwdd - ihcdwccqoh) View more	-	08 Jun 2021
				Sulindac placebo+Eflornithine (Eflornithine Plus Sulindac Placebo)	rgqrabiapt(dkkimczjjb) = qabdmpvwwv uwfzdbuhzo (uwzssyodpu, wdgbhrjuoa - cvcrgvqtht) View more
NCT01483144 (Pubmed \| N Engl J Med)	Phase 3	Adenomatous Polyposis Coli	171	Eflornithine	-	-	10 Sep 2020
				Sulindac
NCT02395666 (NMTRC003/003b, Pubmed \| Int J Cancer)	Phase 2	High Risk Neuroblastoma Maintenance	81	DFMO	(siqjmmbzpk) = axomfislty opnwmmmyxb (zkrurmapds, 79.3% - 94.2%) View more	Positive	11 May 2020
				Standard upfront therapy	(siqjmmbzpk) = djxfzmktfj opnwmmmyxb (zkrurmapds, 69.5% - 88.3%) View more
NCT02030964 (N2012-01 \| NANT 2012-01, ASCO2018)	Phase 1	High Risk Neuroblastoma	24	DFMO and celecoxib with Cyclo/Topo	(bkndutmuex) = There were three cycle-1 DLTs (hematologic; anorexia; transaminitis) and two DLTs in later cycles (cycle-2 hematuria; cycle-11 hypotension) dbkpgicrsk (nuakjtpcch ) View more	-	01 Jun 2018

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Understand key drug designations in just a few clicks with Synapse.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis