eflornithine topical / Generic mfg. - LARVOL DELTA

Combination of Intense Pulsed Light and Topical Eflornithine Therapy Versus Intense Pulsed Light Alone in the Treatment of Idiopathic Facial Hirsutism: A Randomized Controlled Trial. (PubMed, Cureus) - "Adding a topical agent to IPL significantly improves clinical and patient-reported outcomes in IFH without increasing toxicity. The regimen may offer a practical, hormone-free first-line strategy for South-Asian women seeking rapid, durable cosmetic benefits."

Journal • Aesthetic Medicine • Dermatology • Endocrine Disorders

Comparison of a Face Cream Plus a Laser Procedure and Face Cream Alone in Treatment of Excessive Face Hairs in Female (clinicaltrials.gov) - P4 | N=122 | Recruiting | Sponsor: Khyber Teaching Hospital

New P4 trial

Efficacy of Eflornithine Hydrochloride Cream in the Treatment of Melasma: A Randomized, Double-blinded, Split-face Controlled Study (clinicaltrials.gov) - P2 | N=20 | Completed | Sponsor: National Skin Centre

New P2 trial • Dermatology • Dermatopathology

Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma (clinicaltrials.gov) - P2 | N=94 | Active, not recruiting | Sponsor: Children's Oncology Group | Trial completion date: Mar 2025 ➔ Apr 2026

Trial completion date • CNS Tumor • Neuroblastoma • Oncology • Solid Tumor

Norgine strengthens rare disease portfolio with acquisition of Theravia (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....With the acquisition of Theravia, Norgine will now have...core products in its rare disease portfolio (PEDMARQSI, eflornithine, mavorixafor, SIKLOS) thereby comprising a franchise of critical scale with the ability to be a key growth driver in the medium-to-long-term."

M&A • Dermatology • Genetic Disorders • Hematological Disorders • Otorhinolaryngology

Topical Diclofenac and Topical DFMO Chemoprevention Trial in Subjects with a History of Skin Cancer (clinicaltrials.gov) - P2 | N=138 | Active, not recruiting | Sponsor: University of Alabama at Birmingham | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Nov 2024 ➔ Nov 2025

Trial completion date • Trial primary completion date • Genetic Disorders • Oncology • Skin Cancer • Solid Tumor

Evaluating Difluoromethylornithine Safety and Efficacy for Non-Melanoma Skin Cancer Chemoprevention: A Systematic Review. (PubMed, J Cutan Med Surg) - "Current evidence highlights the lack of conclusive data supporting the efficacy of oral DFMO, making it difficult to recommend its use. Conversely, topical DFMO demonstrates more promising outcomes in preventing AKs, presenting a potentially useful alternative in select patients."

Journal • Review • Actinic Keratosis • Basal Cell Carcinoma • CNS Tumor • Colon Cancer • Colorectal Cancer • Dermatology • Gastrointestinal Disorder • Genetic Disorders • Neuroblastoma • Non-melanoma Skin Cancer • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma

Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma (clinicaltrials.gov) - P2 | N=95 | Active, not recruiting | Sponsor: Children's Oncology Group | Trial completion date: Jun 2024 ➔ Mar 2025 | Trial primary completion date: Jun 2024 ➔ Mar 2025

Trial completion date • Trial primary completion date • CNS Tumor • Neuroblastoma • Oncology • Solid Tumor • CD276 • IFNG • IL6 • TNFA

Topical Eflornithine for Pseudofolliculitis Barbae: Randomized Controlled Trial (clinicaltrials.gov) - P4 | N=9 | Terminated | Sponsor: Walter Reed National Military Medical Center | N=25 ➔ 9 | Trial completion date: Dec 2021 ➔ Jun 2023 | Unknown status ➔ Terminated | Trial primary completion date: Jul 2021 ➔ Jun 2023; Vaniqa no longer manufactured

Enrollment change • Trial completion date • Trial primary completion date • Trial termination

Topical Diclofenac and Topical DFMO Chemoprevention Trial in Subjects With a History of Skin Cancer (clinicaltrials.gov) - P2 | N=138 | Active, not recruiting | Sponsor: University of Alabama at Birmingham | Recruiting ➔ Active, not recruiting | Trial primary completion date: Nov 2023 ➔ Nov 2024

Enrollment closed • Trial primary completion date • Genetic Disorders • Melanoma • Oncology • Skin Cancer • Solid Tumor

Eflornithine Hydrochloride-Loaded Electrospun Nanofibers as a Potential Face Mask for Hirsutism Application. (PubMed, Pharmaceutics) - "Laser or electrolysis are alternative methods, but in some cases, the use of medications, such as the topical cream Vaniqa, can help in reducing the growth of unwanted hair...Therefore, this drug-loaded nanofibrous system can be considered a potentially medicated face mask for the management of hirsutism, along with the moisturizing effect that it possesses. Topical applications of the developed system showed reduced hair growth in mice to a certain extent."

Journal

Panbela Therapeutics to Receive a Total Up to $9.5 Million for Divestiture of Assets within Eflornithine (DFMO) Pediatric Neuroblastoma Program to US WorldMeds (GlobeNewswire) - "Panbela Therapeutics, Inc...announced it has divested certain assets in its eflornithine pediatric neuroblastoma program to US WorldMeds^®1 (USWM), a Kentucky-based specialty pharmaceutical company....Under the terms of the agreement, Panbela is entitled to receive up to approximately $9.5 million non-dilutive funding in exchange for the sale of certain assets within its pediatric neuroblastoma program for eflornithine. Panbela will receive payments upon USWM’s successful completion of milestones related to eflornithine's clinical development, regulatory approval, and commercial sales."

Financing • Neuroblastoma • Oncology • Solid Tumor

Panbela Announces Sponsored Research Agreement to Evaluate Polyamine Metabolic Inhibitor Therapy in Combination with CAR-T Cell Therapy (GlobeNewswire) - "Panbela Therapeutics, Inc...announced it has entered into a sponsored research agreement with The University of Texas MD Anderson Cancer Center for the evaluation of polyamine metabolic inhibitor therapies in combination with CAR-T cell therapies in preclinical models. The initial goal of these studies will be to ascertain if eflornithine and/or ivospemin treatment will augment CAR-T mediated cytotoxicity against CD19+ large B-cell lymphoma (LBCL) cell lines."

Licensing / partnership • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Topical Diclofenac and Topical DFMO Chemoprevention Trial in Subjects With a History of Skin Cancer (clinicaltrials.gov) - P2 | N=138 | Recruiting | Sponsor: University of Alabama at Birmingham | Trial completion date: Mar 2023 ➔ Dec 2024 | Trial primary completion date: Jan 2023 ➔ Nov 2023

Trial completion date • Trial primary completion date • Genetic Disorders • Melanoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • CASP3 • CCND1 • CDH1 • GLI1 • GLI2 • GLI3 • HIP1 • PCNA • PTCH1 • SHH • TP53

Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma (clinicaltrials.gov) - P2 | N=95 | Recruiting | Sponsor: Children's Oncology Group | Trial completion date: Mar 2024 ➔ Jun 2024 | Trial primary completion date: Mar 2024 ➔ Jun 2024

Trial completion date • Trial primary completion date • Neuroblastoma • Oncology • Solid Tumor

Topical Diclofenac and Topical DFMO Chemoprevention Trial in Subjects With a History of Skin Cancer (clinicaltrials.gov) - P2 | N=138 | Recruiting | Sponsor: University of Alabama at Birmingham | Trial primary completion date: Jan 2022 ➔ Jan 2023

Trial primary completion date • Genetic Disorders • Melanoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • CASP3 • CCND1 • CDH1 • GLI1 • GLI2 • GLI3 • HIP1 • PCNA • PTCH1 • SHH • TP53

Polycystic ovarian syndrome-current pharmacotherapy and clinical implications. (PubMed, Taiwan J Obstet Gynecol) - "The treatment in PCOS is mainly symptomatic and involves lifestyle interventions and medications such as Metformin, Oral contraceptives and Antiandrogens. Also, evidence suggesting the use of vitamin D, statins, and Letrozole as emerging therapies in PCOS have been summarized in this review. Additionally, novel cosmetic techniques like electrolysis, laser and use of topically applied eflornithine to tackle the most distressing feature of facial hirsutism associated with PCOS, non-pharmacological therapy like acupuncture and the role of herbal medicine in PCOS management have also been discussed."

Journal • Review • Endocrine Disorders • Polycystic Ovary Syndrome

Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma (clinicaltrials.gov) - P2; N=95; Recruiting; Sponsor: Children's Oncology Group; Active, not recruiting ➔ Recruiting

Clinical • Enrollment open • Neuroblastoma • Oncology • Solid Tumor • MRI

Topical Diclofenac and Topical DFMO Chemoprevention Trial in Subjects With a History of Skin Cancer (clinicaltrials.gov) - P2; N=138; Recruiting; Sponsor: University of Alabama at Birmingham; Trial completion date: Mar 2022 ➔ Mar 2023

Clinical • Trial completion date • Genetic Disorders • Melanoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • CASP3 • CCND1 • CDH1 • GLI1 • GLI2 • GLI3 • HIP1 • PCNA • PTCH1 • SHH • TP53

Hair Removal Practices: A Literature Review. (PubMed, Skin Therapy Lett) - "Furthermore, an eflornithine hydrochloride 13.9% cream (Vaniqa®, neither an epilatory or depilatory technique), has been US FDA- and Health Canada-approved to slow the rate of facial hair growth and to be used in combination with other hair removal methods. All methods are temporary except for electrolysis, and each technique has advantages and disadvantages in terms of efficacy and adverse events. Importantly, most studies examining the efficacy of hair removal techniques are limited to darker hair and fairer skin, and further research is required especially for those with light-colored hair."

Journal • Review • Aesthetic Medicine

Norgine B.V. and US WorldMeds enter into exclusive licensing agreement to commercialise DFMO (eflornithine) in Europe, Commonwealth of Independent States, Australia and New Zealand (PRNewswire) - “NORGINE B.V….and US WorldMeds…announced an exclusive licensing agreement by which Norgine will register and commercialise difluoromethylornithine, DFMO (eflornithine) in Europe, Commonwealth of Independent States, Australia and New Zealand. DFMO is a repurposed molecule investigated for use as an extended 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…Under the terms of the license agreement, Norgine will be responsible for the regulatory approval of DFMO and any subsequent clinical trials required for approval in the relevant territories. Norgine will hold marketing authorisations in the licensed territories.”

Licensing / partnership • Neuroblastoma • Oncology

Application of Hantzsch reaction for sensitive determination of eflornithine in cream, plasma and urine samples. (PubMed, R Soc Open Sci) - "Moreover, the proposed work offered a selective determination for EFN in various brands of pharmaceutical cream without any interference from excipients. Eventually, the current approach was assured to be successful in the estimation of EFN in urine and plasma samples with acceptable recovery results."

Journal • Narcolepsy • Sleep Disorder

Micellar sensitized Resonance Rayleigh Scattering and spectrofluorometric methods based on isoindole formation for determination of Eflornithine in cream and biological samples. (PubMed, Spectrochim Acta A Mol Biomol Spectrosc) - "Furthermore, the proposed methods were successfully applied for the assay of Eflornithine in various commercial brands of the pharmaceutical cream samples with good recovery. In addition to the current fluorometric method was confirmed to be effective in the assaying of Eflornithine in spiked plasma and urine specimens with good recovery."

Journal • Narcolepsy • Sleep Disorder

Topical Diclofenac and Topical DFMO Chemoprevention Trial in Subjects With a History of Skin Cancer (clinicaltrials.gov) - P2; N=144; Recruiting; Sponsor: University of Alabama at Birmingham; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Genetic Disorders • Melanoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • CASP3 • CCND1 • CDH1 • GLI1 • GLI2 • GLI3 • PCNA • PTCH1 • TP53

Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma (clinicaltrials.gov) - P2; N=95; Active, not recruiting; Sponsor: Children's Oncology Group; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Ganglioneuroblastoma • Neuroblastoma • Oncology • Solid Tumor