Cortrophin Gel, a purified adrenocorticotropic hormone (ACTH), has been approved by the US Food and Drug Administration (FDA) for the treatment of acute exacerbations of multiple sclerosis (MS) among other autoimmune conditions. 

Cortrophin Gel was approved for the first time in 1954. Since then, it has been used for the treatment of a number of chronic autoimmune disorders. The manufacturing processes of the treatment have been updated over the past 5 years by ANI Pharmaceuticals.

In June 2021, the company submitted a supplemental new drug application to the FDA to bring Cortrophin Gel back to the market. It anticipates a full-scale commercial launch by the beginning of next year.

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“We are pleased to offer Cortrophin Gel, an established treatment, to provide another option to patients and prescribers,” Nikhil Lalwani, president and chief executive officer of ANI Pharmaceuticals, said in a press release from the company.

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Corticosteroids are often used to treat relapses in MS. However, some patients cannot tolerate these treatments or do not respond to them. These patients are at a particularly high risk of organ damage due to the disease and have a particularly urgent need for an alternative treatment.

Purified ACTH in Cortrophin Gel causes the adrenal glands to naturally produce cortisol, corticosterone, and aldosterone without the need to supply it to the body externally.

“For over 30 years, there has only been one available treatment in the ACTH category. With the FDA approval of Cortrophin Gel, patients will now have a significant new treatment option,” ANI Pharmaceuticals chief medical officer Mary Pao Seideman, MD, PhD, said.

The other diseases that Cortrophin Gel has been approved for include rheumatoid arthritis and nephrotic syndrome.


ANI Pharmaceuticals announces FDA approval of purified Cortrophin™ Gel for multiple indications including multiple sclerosis, rheumatoid arthritis and nephrotic syndrome. News release. Ani Pharmaceuticals; November 1, 2021.