Genovate to Apply for PMR Drug Approval with FDA in Late 2025

Genovate Biotechnology Co., Ltd., a Taiwan-based specialty pharmaceuticals firm, has announced its intention to file a New Drug Application (NDA) with the United States Food and Drug Administration (US FDA) for PMR, a once-daily extended-release form of cilostazol. This application is aimed at gaining approval for the treatment of Intermittent Claudication (IC) and is scheduled for submission in the latter half of 2025.

According to the FDA, the clinical research performed to date is adequate to warrant a marketing application under the 505(b)(2) regulatory pathway. Central to the submission package is study GBL23-001 (NCT06167265), a randomized crossover study that examines the bioequivalence and variability between a daily 145 mg dose of PMR and a 100 mg immediate-release tablet taken twice daily. This study is anticipated to conclude by mid-2024, and preliminary results have already met the primary endpoints, prompting the decision to move forward with the NDA. Genovate is also enhancing the PMR formulation and manufacturing processes in response to FDA feedback. All relevant clinical and manufacturing data will be included in the final submission.

Genovate’s General Manager, Chia-Chen Chu, expressed optimism about the regulatory pathway for PMR, emphasizing the potential to offer a new treatment option for those suffering from IC and recurrent cerebral infarctions, both in the US and globally.

PMR is a new extended-release formulation of cilostazol, designed to mitigate the concentration-dependent side effects seen with the immediate-release (IR) version. Currently, cilostazol IR tablets are available in 50 and 100 mg doses and are taken twice daily. Marketed as Pletal® in the US and Pletaal® in Taiwan and other Asian countries, cilostazol was first introduced in Japan in 1988 for the treatment of peripheral arterial diseases and the prevention of recurrent cerebral infarctions. The US FDA later approved it in 1999 for IC treatment. Cilostazol, a PDE III inhibitor, is known to reduce platelet aggregation and increase vasodilation, effectively preventing secondary strokes and reducing ischemic stroke recurrence. However, adverse reactions such as headaches, palpitations, and diarrhea have led to a 15.4% withdrawal rate in clinical trials, primarily due to the peak concentration of the drug. PMR aims to enhance patient adherence and minimize these side effects by providing a more consistent drug concentration.

Peripheral arterial disease (PAD), which affects over 200 million people worldwide and around 8.5 million Americans over 40, often leads to IC—a condition characterized by pain and cramping in the lower extremities due to restricted blood flow. IC symptoms usually worsen with physical activity and improve with rest but can significantly impact the quality of life. Although severe cases may require surgical intervention, IC is typically managed through a combination of medications, lifestyle changes, and exercise. Drugs that enhance blood flow, like anti-clotting agents, antihypertensives, statins, and PDE III inhibitors such as cilostazol, are commonly used to treat IC.

Genovate Biotechnology Co., Ltd. is a fully integrated specialty pharmaceutical company based in Taiwan, focusing on developing new drug formulations, active ingredients, and treatment modalities for cardiovascular, autoimmune, neurodegenerative, and liver diseases. The company is equipped with PIC/S GMP manufacturing, marketing, and distribution capabilities.

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