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Overview

Tags

Urogenital Diseases

Infectious Diseases

Other Diseases

Small molecule drug

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Infectious Diseases	3
Hemic and Lymphatic Diseases	1
Nervous System Diseases	1
Neoplasms	1

Top 5 Drug Type	Count

Small molecule drug	4

Top 5 Target	Count

30S subunit(30S ribosomal subunit)	1
AR x ER x MR x PR	1
EPT(UDP-N-acetylglucosamine 1-carboxyvinyltransferase)	1
fungal CYP51A1	1

The purpose of this study is to determine how safe, effective, and well tolerated a new investigational antifungal drug, SUBA-itraconazole, is for patients who have been previously treated with fluconazole and have had either an insufficient response to treatment with fluconazole or a negative reaction to fluconazole preventing their further treatment with it.

Start Date15 May 2021

Sponsor / Collaborator

University of California, Davis

[+1]

NCT03948464 / TerminatedPhase 3IIT

Repurposing Slow-Release Oral Morphine as a New Oral Alternative for the Treatment of Opioid Use Disorder

This is a non-inferiority randomized clinical trial that will compare slow release oral morphine vs methadone as a second line oral treatment for opioid use disorder.

Start Date06 Dec 2019

Sponsor / Collaborator

Canadian Institutes of Health Research

[+2]

NCT03980223 / CompletedPhase 4IIT

Evaluation of Doxycycline Post-exposure Prophylaxis to Reduce Sexually Transmitted Infections in PrEP Users and HIV-infected Men Who Have Sex With Men

The purpose of this study is to understand if taking an antibiotic called doxycycline by mouth as soon as possible after sexual contact without a condom can reduce the risk of sexually transmitted infections (STIs), including gonorrhea, chlamydia and syphilis. The study will also look at the safety of doxycycline PEP and the impact that PEP may have on the bacteria that cause STIs as well as on bacteria that normally live on the body. While doxycycline is approved by the Food and Drug Administration (FDA), taking doxycycline immediately after sexual contact to prevent infection is investigational and is not approved by the FDA for this use. Participants will take part in the study for 1 year.

Start Date26 Nov 2019

Sponsor / Collaborator

The University of California, San Francisco

[+4]

100 Clinical Results associated with Mayne Pharma International Pty Ltd.

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0 Patents (Medical) associated with Mayne Pharma International Pty Ltd.

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12

Literatures (Medical) associated with Mayne Pharma International Pty Ltd.

17 Nov 2023·Oncogene

Ligand-dependent hedgehog signaling maintains an undifferentiated, malignant osteosarcoma phenotype

Article

Author: McCaw, Andrew ; Thomas, David M ; Jayasekara, W Samantha N ; Kumar, Beena ; Szczepny, Anette ; Martelotto, Luciano G ; Cochrane, Catherine R ; Vaghjiani, Vijesh G ; Mudge, Stuart ; Gough, Daniel J ; Watkins, D Neil ; Downie, Peter A ; Matsui, William ; Peacock, Craig D ; Walkley, Carl ; Carey, Kirstyn ; Kansara, Maya ; Chong, Wai Chin ; Cain, Jason E

AbstractTP53andRB1loss-of-function mutations are common in osteosarcoma. During development, combined loss of TP53 and RB1 function leads to downregulation of autophagy and the aberrant formation of primary cilia, cellular organelles essential for the transmission of canonical Hedgehog (Hh) signaling. Excess cilia formation then leads to hypersensitivity to Hedgehog (Hh) ligand signaling. In mouse and human models, we now show that osteosarcomas with mutations inTP53andRB1exhibit enhanced ligand-dependent Hh pathway activation through Smoothened (SMO), a transmembrane signaling molecule required for activation of the canonical Hh pathway. This dependence is mediated by hypersensitivity to Hh ligand and is accompanied by impaired autophagy and increased primary cilia formation and expression of Hh ligand in vivo. Using a conditional genetic mouse model ofTrp53andRb1inactivation in osteoblast progenitors, we further show that deletion ofSmoconverts the highly malignant osteosarcoma phenotype to benign, well differentiated bone tumors. Conversely, conditional overexpression of SHH ligand, or a gain-of-function SMO mutant in committed osteoblast progenitors during development blocks terminal bone differentiation. Finally, we demonstrate that the SMO antagonist sonidegib (LDE225) induces growth arrest and terminal differentiation in vivo in osteosarcomas that express primary cilia and Hh ligand combined with mutations in TP53. These results provide a mechanistic framework for aberrant Hh signaling in osteosarcoma based on defining mutations in the tumor suppressor, TP53.

01 Apr 2019·European Journal of Drug Metabolism and PharmacokineticsQ4 · MEDICINE

Mechanistic Assessment of the Effect of Omeprazole on the In Vivo Pharmacokinetics of Itraconazole in Healthy Volunteers

Q4 · MEDICINE

Article

Author: Abuhelwa, Ahmad Y ; Foster, David J R ; Upton, Richard N ; Mudge, Stuart

BACKGROUND AND OBJECTIVESUBA-itraconazole and Sporanox are two oral formulations of itraconazole. Drug-drug interactions with omeprazole have been previously reported; however, mechanistic understanding of the pharmacological and physiological interactions of omeprazole with orally administered itraconazole within a population modeling paradigm is lacking. The objective of this analysis was to mechanistically describe and quantify the effect of omeprazole on the pharmacokinetics of itraconazole and its major metabolite, hydroxyitraconazole from the SUBA itraconazole and Sporanox formulations.METHODSAn in vitro-in vivo (IVIV) pharmacokinetic model of itraconazole and hydroxyitraconazole was developed including data from an omeprazole interaction study with SUBA itraconazole. Meta-models of gastric pH for healthy subjects and subjects receiving omeprazole were integrated into the IVIV model to capture omeprazole-mediated gastric pH changes on itraconazole dissolution and absorption.RESULTSOmeprazole influenced the kinetics of itraconazole through altering the dissolution and absorption due to the pH-dependent solubility of itraconazole, inhibition of efflux transporters, and inhibiting the metabolism of itraconazole and hydroxyitraconazole. The model-predicted population effects of omeprazole on itraconazole from SUBA-itraconazole were to increase the area under the concentration-time curve (AUC_0-24) and maximum concentration (C_max) by 35 and 31%, respectively, and to decrease AUC_0-24 and C_max from Sporanox by 68 and 76%, respectively.CONCLUSIONUnlike SUBA itraconazole, which requires basic pH for itraconazole release, the omeprazole-induced pH-mediated reduction in Sporanox dissolution overrides any increased exposure from the drug-drug interaction at hepatic metabolizing enzymes or efflux transporters. The model presented here is the most complete quantitative description of the pharmacokinetics of itraconazole and hydroxyitraconazole currently available.

01 Dec 2018·Antimicrobial Agents and ChemotherapyQ2 · MEDICINE

Effects of Food and Omeprazole on a Novel Formulation of Super Bioavailability Itraconazole in Healthy Subjects

Q2 · MEDICINE

Article

Author: Thompson, George R. ; Lindsay, Julian ; Mudge, Stuart

To address the limited bioavailability and intolerance of the conventional itraconazole (ITZ) formulations, a new formulation labeledsuperbioavailability (SUBA) itraconazole has been developed; however, the specific effects of food and gastric pH are unknown. This study evaluated the pharmacokinetic profile of SUBA itraconazole under fasting and fed conditions, as well as with the concomitant administration of a proton pump inhibitor.

100 Deals associated with Mayne Pharma International Pty Ltd.

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100 Translational Medicine associated with Mayne Pharma International Pty Ltd.

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Pipeline

Pipeline Snapshot as of 24 Dec 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

IND Approval

1

4

Approved

Other

2

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Fosfomycin Tromethamine ( EPT )	Urinary Tract Infections More	Approved
Drospirenone/Estetrol ( AR x ER x MR x PR )	Contraception More	Approved
Doxycycline Hyclate ( 30S subunit )	Severe acne More	Approved
Itraconazole ( fungal CYP51A1 )	Histoplasmosis More	Approved
Morphine Sulfate ( Opioid receptors )	Cancer Pain More	IND Approval