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

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

"MSG-15 RCT evaluating SUBA-itraconazole vs conventional itraconazole for endemic mycoses is ongoing. #Coccidioidomycosis #IDWeek2022" (@LordAlirezaF)

Dermatology • Infectious Disease • Respiratory Diseases

MSG15: Endemic Mycoses Treatment With SUBA-itraconazole vs Itraconazole (clinicaltrials.gov) - P2/3 | N=88 | Completed | Sponsor: University of Alabama at Birmingham | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Infectious Disease

SUBA-Itraconazole for Primary Antifungal Prophylaxis After Allogeneic Hematopoietic Cell Transplantation. (PubMed, Open Forum Infect Dis) - "The geometric mean trough plasma ITZ concentration was 1130ng/mL (interquartile range, 566-1801ng/mL; coefficient of variation, 56.57%) and the median time to achieve therapeutic levels was 10 days. S-ITZ is a safe and well-tolerated oral formulation and is a novel alternative for primary IFD prophylaxis after HCT."

Journal • Acute Graft versus Host Disease • Bone Marrow Transplantation • Gastrointestinal Disorder • Graft versus Host Disease • Immunology • Infectious Disease • Transplantation

HITMAN: Phase I/II Study of Hydroxychloroquine With Itraconazole With Biochemically Recurrent Prostate Cancer (clinicaltrials.gov) - P1/2 | N=27 | Recruiting | Sponsor: St Vincent's Hospital, Sydney | Trial completion date: Mar 2023 ➔ Jul 2024 | Trial primary completion date: Mar 2022 ➔ Mar 2023

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

MSG15: Endemic Mycoses Treatment With SUBA-itraconazole vs Itraconazole (clinicaltrials.gov) - P2/3; N=80; Active, not recruiting; Sponsor: University of Alabama at Birmingham; Trial completion date: Oct 2021 ➔ Apr 2022

Clinical • Trial completion date • Dermatology • Infectious Disease

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

Clinical • New P1/2 trial • Oncology • Ovarian Cancer • Solid Tumor

[VIRTUAL] An open-label comparative trial of SUBA-itraconazole (SUBA) versus conventional itraconazole (c-itra) for treatment of proven and probable endemic mycoses (MSG-15): a pharmacokinetic (PK) and adverse Event (AE) analysis (IDWeek 2021) - No abstract available

Adverse events • Clinical • PK/PD data • Infectious Disease

[VIRTUAL] Suba-itraconazole or Isavuconazole for Prophylaxis and Treatment of Invasive Fungal Infections: Ready for Prime Time? (IDWeek 2021) - No abstract available

Infectious Disease

MSG15: Endemic Mycoses Treatment With SUBA-itraconazole vs Itraconazole (clinicaltrials.gov) - P2/3; N=80; Active, not recruiting; Sponsor: University of Alabama at Birmingham; Recruiting ➔ Active, not recruiting; Trial completion date: May 2020 ➔ Oct 2021; Trial primary completion date: May 2020 ➔ May 2021

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Dermatology • Infectious Disease

[VIRTUAL] A phase I/II study of hydroxychloroquine and suba-itraconazole in men with biochemical relapse of prostate cancer (HITMAN-PC): Dose escalation results. (ASCO-GU 2021) - P1/2 | "HCQ/SI demonstrated acceptable safety with MTD 600mg BD and RP2D 400mg BD. There is early signal of activity and phase II enrolment is to begin."

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