Tolsura (SUBA-itraconazole) / Inhibitor Therap, Mayne Pharma - LARVOL DELTA

Itraconazole in Combination With Ablation for the Prevention of Esophageal Cancer in Patients With High-risk Barrett's Esophagus (clinicaltrials.gov) - P2 | N=76 | Recruiting | Sponsor: National Cancer Institute (NCI) | Not yet recruiting ➔ Recruiting | Trial completion date: Feb 2030 ➔ Dec 2030 | Trial primary completion date: Feb 2030 ➔ Aug 2030

Enrollment open • Trial completion date • Trial primary completion date • Barrett Esophagus • Esophageal Adenocarcinoma • Esophageal Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor

C2321001: A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma (clinicaltrials.gov) - P1 | N=453 | Recruiting | Sponsor: Pfizer | Trial completion date: Mar 2029 ➔ Jul 2029

Trial completion date • Castration-Resistant Prostate Cancer • Follicular Lymphoma • Genito-urinary Cancer • Hematological Malignancies • Lung Cancer • Lymphoma • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor

KOMET-001: First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2 | N=263 | Active, not recruiting | Sponsor: Kura Oncology, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • First-in-human • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • KMT2A • MEIS1 • NPM1

Itraconazole in Combination With Ablation for the Prevention of Esophageal Cancer in Patients With High-risk Barrett's Esophagus (clinicaltrials.gov) - P2 | N=64 | Not yet recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jan 2028 ➔ Feb 2030 | Trial primary completion date: Jan 2028 ➔ Feb 2030

Trial completion date • Trial primary completion date • Barrett Esophagus • Esophageal Adenocarcinoma • Esophageal Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor

A phase I study of hydroxychloroquine and suba-itraconazole in men with biochemical relapse of prostate cancer (HITMAN-PC): dose escalation results. (PubMed, Cancer Res Commun) - "Despite limited clinical activity overall, the identified lipidomic signatures provide proof-of-concept for using plasma lipidomics to monitor pharmacodynamic activity in future metabolism-targeted trials."

Journal • P1 data • Cardiovascular • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hypertension • Oncology • Prostate Cancer • Solid Tumor

A phase I/II study to assess the toxicity and preliminary efficacy of SUBA-itraconazole and dual checkpoint inhibitor cadonilimab as maintenance therapy in advanced pancreatic ductal adenocarcinoma (LCC 2026) - "Blood and tumour tissue will be collected to investigate the pharmacokinetics of study drug treatments, identify potential biomarkers and explore changes in immune cell populations. Conclusion Based on preclinical evidence demonstrating that itraconazole can modulate PDAC TME and improve immunotherapy responses; our clinical trial design will investigate the safety and preliminary efficacy of SUBA-itraconazole and immunotherapy as maintenance treatment in advanced pancreatic cancer."

Checkpoint inhibition • Clinical • IO biomarker • Metastases • P1/2 data • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CD4 • CD8 • FOXP3

New and emerging drugs for the treatment of invasive fungal infections. (PubMed, Expert Opin Pharmacother) - "Data were identified using PubMed searches for the terms 'antifungal,' 'olorofim,' 'SUBA-itraconazole,' 'ibrexafungerp,' 'rezafungin,' 'fosmanogepix,' and 'encochleated amphotericin B.' Approved agents include ibrexafungerp, an oral triterpenoid inhibitor of 1,3-β-D-glucan synthase; rezafungin, a long-acting echinocandin with weekly dosing; and SUBA-itraconazole, a reformulation of itraconazole with more consistent absorption. Despite improvements, gaps remain in treatments for severe IFI, particularly given increasing resistance. These agents represent significant advances, but further research is needed to define their use in patient management."

Journal • Review • Dermatology • Infectious Disease

Itraconazole in Combination With Ablation for the Prevention of Esophageal Cancer in Patients With High-risk Barrett's Esophagus (clinicaltrials.gov) - P2 | N=64 | Not yet recruiting | Sponsor: National Cancer Institute (NCI) | Initiation date: Jun 2025 ➔ Oct 2025

Trial initiation date • Barrett Esophagus • Esophageal Adenocarcinoma • Esophageal Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor

KOMET-001: First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2 | N=263 | Recruiting | Sponsor: Kura Oncology, Inc. | N=199 ➔ 263

Enrollment change • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • KMT2A • NPM1

TICTOC: Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer (clinicaltrials.gov) - P1 | N=44 | Active, not recruiting | Sponsor: Anthony Joshua, FRACP | Phase classification: P1/2 ➔ P1 | Trial completion date: Jan 2025 ➔ Jan 2027 | Trial primary completion date: Jan 2024 ➔ Jan 2026 | Recruiting ➔ Active, not recruiting

Enrollment closed • Phase classification • Platinum resistant • Trial completion date • Trial primary completion date • Epithelial Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor

A physiologically based biopharmaceutics modeling (PBBM) framework for characterizing formulation-dependent food effects: paving the road towards fed virtual BE studies for itraconazole amorphous solid dispersions. (PubMed, Eur J Pharm Sci) - "This study leverages physiologically based biopharmaceutics modeling (PBBM) to predict the clinical performance of two itraconazole (ITRA) amorphous solid dispersions (ASDs), Sempera® and Tolsura®, under fasted and fed state conditions, exploring the potential of PBBM in predicting formulation-specific food interactions. The findings highlight the importance of considering formulation characteristics and gastrointestinal physiology, underscoring the potential of PBBM in bioequivalence (BE) assessment of generic formulations under varying physiological conditions, including in the fed state and in hypochlorhydric patients. The successful application of this stepwise and mechanistic PBBM approach suggests a potential pathway for streamlining drug development and may contribute to more informed decision-making for BE assessment."

Journal • Gastrointestinal Disorder

Itraconazole in Combination With Ablation for the Prevention of Esophageal Cancer in Patients With High-risk Barrett's Esophagus (clinicaltrials.gov) - P2 | N=64 | Not yet recruiting | Sponsor: National Cancer Institute (NCI)

Combination therapy • New P2 trial • Barrett Esophagus • Esophageal Adenocarcinoma • Esophageal Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor

SUBA-itraconazole in the treatment of systemic fungal infections. (PubMed, Future Microbiol) - "Given the significant differences in pharmacokinetics between the formulations, c-ITZ and SUBA-ITZ capsules are not considered interchangeable. It is important to note that drug errors may occur when transitioning a patient from one formulation to another."

Journal • Review • Cardiovascular • Gastroenterology • Gastrointestinal Disorder • Hypertension • Infectious Disease • Pulmonary Disease • Respiratory Diseases

A Case of Miliary Histoplasmosis of the Lung With Bullous Formation (ATS 2024) - "The patient was subsequently treated with SUBA-Itraconazole for one year...Progression of bullous formation from chronic inflammation may lead to lung volume loss and respiratory failure. This is an atypical case of miliary pulmonary histoplasmosis with rapid development of bullous emphysematous lung disease secondary to proposed chronic inflammation in spite of appropriate antifungal therapy."

Clinical • Bronchiectasis • Cough • Fibrosis • Immunology • Infectious Disease • Inflammation • Pulmonary Disease • Respiratory Diseases • Tobacco Cessation

In vitro lipolysis model to predict food effect of poorly water-soluble drugs itraconazole, rivaroxaban, and ritonavir. (PubMed, J Pharm Sci) - "For itraconazole, all four products were correctly predicted, with Sporanox, Sempera, and generic capsules having a food effect, but Tolsura not having a positive food effect. For ritonavir, lipolysis predicted a positive food effect for API and Norvir tablet and powder, but Norvir products have negative food effect in vivo in humans. Overall, the lipolysis model showed favorable predictability and merits additional evaluation."

Journal • Preclinical • Gastrointestinal Disorder

Super Bioavailable (SUBA) Itraconazole-Induced Galactorrhea-Could it be due to Hydroxypropyl Methylcellulose Phthalate? (PubMed, Indian Dermatol Online J) - No abstract available

Journal

IADVL SIG Recalcitrant Dermatophytosis Position Statement on Super Bioavailable Itraconazole. (PubMed, Indian Dermatol Online J) - "Indian Association of Dermatologists, Venereologists and Leprologists (IADVL) has established a special interest group for recalcitrant dermatophytosis (SIG-RD) to strengthen research, continuing medical education, and industry collaboration on the subject. This position statement on SUBA-ITZ by SIG-RD is an attempt to address current pieces of evidence and the position of this new formulation in the management of RD."

Journal • Dermatology

HITMAN: Phase I/II Study of Hydroxychloroquine With Itraconazole With Biochemically Recurrent Prostate Cancer (clinicaltrials.gov) - P1/2 | N=12 | Completed | Sponsor: St Vincent's Hospital, Sydney | Active, not recruiting ➔ Completed | Trial completion date: Jul 2024 ➔ Oct 2023 | Trial primary completion date: Mar 2023 ➔ Aug 2023

Trial completion • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Recurrent tinea corporis generalisata due to Terbinafine-resistant Trichophyton rubrum strain : Long-term treatment with super bioavailability itraconazole (PubMed, Dermatologie (Heidelb)) - "A therapy attempt with voriconazole was successful, but was stopped due to side effects...Topically, ciclopirox and miconazole cream were used alternately...An in vitro resistance test and point mutation analysis of the squalene epoxidase gene confirms the diagnosis. Itraconazole, also in the form of SUBA itraconazole, is the drug of choice for the oral antifungal treatment of these patients."

Journal • Review • Dermatology • SQLE

Evaluation of Tolsura When Used as Prophylaxis After Lung Transplantation (clinicaltrials.gov) - P=N/A | N=0 | Withdrawn | Sponsor: Hong Nguyen | N=50 ➔ 0 | Trial completion date: Dec 2025 ➔ Apr 2023 | Recruiting ➔ Withdrawn | Trial primary completion date: Dec 2025 ➔ Apr 2023

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Infectious Disease • Transplantation

THE EFFECT OF THERAPEUTIC PLASMA EXCHANGE ON ITRACONAZOLE PHARMACOKINETICS: A CASE STUDY. (PubMed, Ther Drug Monit) - "Immunosuppression resulted in Aspergillus lentulus pulmonary infection, requiring treatment with SUBA-itraconazole. This was confirmed by sampling of the TPE plasmapheresate, which revealed that changes in plasma concentration overestimated itraconazole clearance. These findings highlight that the pharmacokinetics of itraconazole are altered during TPE, which should be considered when timing drug administration and obtaining plasma concentrations."

Journal • PK/PD data • Dermatomyositis • Immunology • Infectious Disease • Myositis • Respiratory Diseases

TICTOC: Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer (clinicaltrials.gov) - P1/2 | N=44 | Recruiting | Sponsor: Anthony Joshua, FRACP | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Ovarian Cancer • Solid Tumor

HITMAN: Phase I/II Study of Hydroxychloroquine With Itraconazole With Biochemically Recurrent Prostate Cancer (clinicaltrials.gov) - P1/2 | N=12 | Active, not recruiting | Sponsor: St Vincent's Hospital, Sydney | Recruiting ➔ Active, not recruiting | N=27 ➔ 12

Enrollment change • Enrollment closed • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A CASE OF COCCIDIOIDOMYCOSIS MENINGITIS TREATED WITH SUBAITRACONAZOLE. (WSMRF 2023) - No abstract available

Clinical • CNS Disorders • Infectious Disease • Respiratory Diseases

[VIRTUAL] A phase I/II study of hydroxychloroquine and suba-itraconazole in men with biochemical relapse of prostate cancer (HITMAN-PC): dose escalation results (MOGA ASM 2020) - "HCQ/SI demonstrated acceptable safety with MTD 600 mg BD and RP2D 400 mg BD. There is early signal of efficacy and phase II enrolment is to begin."

P1/2 data • Genito-urinary Cancer • Hypertension • Oncology • Prostate Cancer • Solid Tumor