Certa Therapeutics Expands GPR68 Platform through Acquisition of OccuRx
Strengthened Pipeline Targets Multiple Fibrotic Diseases Melbourne, Australia 19 December 2024: Certa Therapeutics (Certa), a biotechnology company developing innovative precision therapies for patients with fibrotic diseases, today announces the acquisition of OccuRx, a Melbourne-based biotechnology company with highly complementary assets, resources and expertise, and a shared focus on targeting GPR68, a master switch of fibrosis. The […]
Certa Therapeutics Team Publishes Article in Drug Discovery World Ahead of JP Morgan Conference
Certa Therapeutics is proud to announce that our team members—Darren Kelly, Michelle Papdimitriou, and Simona Carbone—have published a thought-provoking article in the latest edition of Drug Discovery World. The article, titled “Is GPR68 a Potential Master Switch for Fibrotic and Inflammatory Diseases”, explores the pivotal role of GPR68 in driving inflammation and fibrosis across a range of […]
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Certa Therapeutics Announces International Non-Proprietary Name for its First-in-class GPR68 Inhibitor Asengeprast (FT011)

Melbourne, Australia 16 September 2024: Certa Therapeutics (Certa), a biotechnology company developing innovative precision therapies for patients with fibrotic diseases, today announces that its lead candidate FT011 has been granted the International Non-Proprietary Name (INN) of ‘asengeprast’ by the World Health Organisation (WHO). Commonly known as a generic name, an INN is a globally recognised, […]
Certa Therapeutics Receives EU Orphan Designation for FT011, a GPR68 Inhibitor Being Developed as an Anti-Fibrotic Treatment for Systemic Sclerosis

Melbourne, Australia 22 July 2024: Certa Therapeutics (Certa), a biotechnology company developing innovative precision therapies for patients with inflammatory and fibrotic diseases, today announces that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) for its lead drug candidate, FT011, as a potential treatment of Systemic Sclerosis (SSc). Certa has previously also received […]
Certa Therapeutics’ FT011 Granted US FDA Fast Track for the Treatment of Systemic Sclerosis

Melbourne, Australia 19 February 2024: Certa Therapeutics (Certa), a biotechnology company developing innovative precision therapies for patients with inflammatory and fibrotic diseases, today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational therapy FT011 for the treatment of systemic sclerosis (scleroderma), having previously granted Orphan Drug Designation. […]
Certa Therapeutics presents positive data from a Phase 2 clinical study highlighting the potential benefit of FT011 as a novel treatment for scleroderma

Melbourne, Australia: 16 November 2023 – Certa Therapeutics (Certa), a biotechnology company developing innovative precision therapies for patients with inflammatory and fibrotic diseases, announces the presentation of results of its Phase 2 clinical trial of FT011 in patients with scleroderma at ACR Convergence 2023, the annual scientific meeting of the American College of Rheumatology being […]
ABSTRACT: FT011 for the treatment of Systemic Sclerosis. Results from a Phase II study.

Authors: Christopher P. Denton1, Wendy Stevens2, Nicole Kruger3, Michelle Papadimitriou3,4, Fay Khong3,4, Michelle Bradney3, Darren J. Kelly3,4, Robert Lafyatis5. 1Centre for Rheumatology, Royal Free Hospital, London, United Kingdom, 2Department of Rheumatology, St Vincent’s Hospital, Melbourne, Vic., Australia, 3Certa Therapeutics Pty Ltd, Melbourne Vic., Australia, 4Department of Medicine, Melbourne University, Melbourne Vic. Australia, 5Division of Rheumatology, […]
Certa Therapeutics’ FT011 Granted US FDA Orphan Drug Designation for the Treatment of Systemic Sclerosis

Melbourne, Australia: 23 October 2023- Certa Therapeutics (Certa), a biotechnology company developing innovative precision therapies for patients with inflammatory and fibrotic diseases, today announces that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for its investigational therapy FT011 for the treatment of systemic sclerosis (scleroderma). Orphan Drug Designation is granted by the […]
Certa Therapeutics represented at Biotechnology Innovation Organisation (BIO) International Convention in Boston

Melbourne, Australia, 05 June 2023: Certa Therapeutics, a biotechnology company focused on improving lives by developing innovative precision treatments for inflammatory and fibrotic diseases, announced today that its Executive Chair, Professor Darren Kelly and Chief Commercial Officer, Dr Gareth Lewis, will be attending the 2023 Biotechnology Innovation Organisation International Convention (BIO) from 5-8 June in Boston. […]