Acrux

Acrux is a specialty pharma company with a successful track record of developing and commercialising a pipeline of topically applied pharmaceutical products. Drawing on 25 years of experience, Acrux has successfully marketed through licensees a number of products worldwide with emphasis on the United States. The company is formulating and developing a range of topical generic products by leveraging its highly skilled workforce, on-site laboratories, GMP manufacturing suite, technical, clinical and commercial experience to bring affordable products to market. Acrux is a dynamic Australian drug delivery company developing and commercialising patient preferred healthcare products for global markets. It was incorporated in 1998 and listed on the ASX in 2004 (ACR:ASX).

Acrux was incorporated in 1998. In 2001, the company received its first US patent. In 2003, Recuvyra® Veterinary product was licensed to Elanco globally. In 2004, Acrux listed on the ASX (ACR:ASX). In 2007, Evamist® was licensed to KV Pharmaceutical in the US, and in 2008 Evamist® was launched by KV Pharmaceutical. In 2010, Acrux submitted the Axiron® NDA to the FDA, and in 2011 Axiron® was launched by Eli Lilly. In 2014, Evamist® was licensed to Perrigo in the US. In 2016, Lenzetto® was launched in Europe by licensee Gedeon Richter. In 2018, Acrux submitted its first two ANDA (generic) products to the FDA for review. In 2019, Acrux submitted a third ANDA (generic) product to the FDA for review; Lenzetto® was marketed in over 30 countries in Europe and other countries outside Europe; and the company had an active pipeline of 14 generic products. In 2020, Acrux entered a development agreement with commercial organisations for marketing of the Acrux developed ANDA products in the United States. In 2022, Acrux had 6 ANDAs accepted for review by the FDA, and an AB-rated generic version of Emla® Cream (Lidocaine 2.5% and Prilocaine 2.5% Cream) was launched in the USA in December 2022 by Acrux licensee Padagis. As at August 2023, Acrux had six approved products with 3 ANDAs under review by the FDA. In 2024, the FDA approved Dapsone 7.5% Gel and Nitroglycerine 0.4% Ointment, and Dapsone 5% Gel was launched. In 2025, 90g Dapsone 5% Gel was launched.

Specialty pharma company focused on topically applied pharmaceutical products and drug delivery.

• Dapsone 7.5% Gel

• Nitroglycerine 0.4% Ointment

• Dapsone 5% Gel

• Lidocaine and Prilocaine Cream, USP 2.5%/2.5%

• LENZETTO®

• EVAMIST®

1. 1Acruxacrux.com.au
2. 2Acrux History - Acruxacrux.com.au
3. 3Products Archive - Acruxacrux.com.au
4. 4Our Values - Acruxacrux.com.au