Leprosy is a chronic infection of skin and peripheral nerves caused by Mycobacterium leprae . Almost 4 million people have been affected by leprosy and nearly 250,000 new cases are still being detected annually throughout the world. WHO recommended multidrug therapy (MDT) which has been the mainstay of treatment for leprosy and in reducing its prevalence to near elimination levels. However, lepra reactions and nerve damage cause significant morbidity among patients affected with leprosy. Apart from well-established treatment with systemic corticosteroids and thalidomide, and many anti-inflammatory and immunomodulator drugs, oral zinc has been found useful in the management of lepra reactions owing to its immunostimulatory properties. Zinc is found to stimulate production of IL-2 and induces a shift from Th2 to Th1 response. It has also been demonstrated to decrease the serum levels of TNF- α and inhibit the TNF- α induced apoptosis of peripheral blood mononuclear cells that helps in controlling the disease activity and reactional states [ 14 ]. In a study comprising patients of recurrent erythema nodosum leprosum additionally receiving zinc, the steroids could be tapered off completely and the duration and severity of reaction were also reduced [ 15 ]. Addition of oral zinc to antileprosy treatment too has been shown to improve therapeutic outcome. Oral zinc when given as an adjuvant to dapsone in lepromatous leprosy induced rapid lepromin conversion and bacterial clearance in the patients as compared to the control group. The clinical improvement was also faster in patients receiving zinc as an adjuvant along with standard MDT [ 16 ]. Oral zinc perhaps makes an adjuvant of choice in leprosy treatment.
However, in December 2004 the United States the 14-member Food and Drug Administration (FDA) advisory committee, plus voting consultants, for Reproductive Health Drugs unanimously rejected Procter and Gamble's fast-track request for Intrinsa citing concerns about off-label use . In Canada, post-menopausal women have been able to obtain government-approved testosterone treatment since 2002. In Australia, post-menopausal women can use Organon testosterone implants which have to be surgically inserted and last from three to six months. 
Ligand Pharmaceuticals has patents filed for the manufacture and therapeutic use of certain compounds occupying several stated chemical structures, which are intended for use as selective androgen receptor modulators. The patent is filed under the following designations: US8519158 B2, US8865918, US9359285, US20070254875, US20140005186, US20150099720, and WO2005090282A1. The patents will expire on March 12, 2025. These patents effectively protect any future capitalization upon VK5211 in the market by Viking and Ligand through their licensing agreement.