Orgovyx Tablet, Film Coated
Product Images NDC 72974-120

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Orgovyx (NDC 72974-120). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sumitomo Pharma America, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Chemical Structure (Orgovyx 01)

Chemical structure of relugolix, the active ingredient in Orgovyx 120 mg tablets. The structure depicts a complex arrangement of aromatic rings, heteroatoms including nitrogen, oxygen, sulfur, and fluorine, as well as methoxy and dimethylamino substituents.*

FDA Label Image

Figure 1 (Orgovyx 02)

Line charts depicting mean concentrations of Follicle-Stimulating Hormone (FSH) and Luteinizing Hormone (LH) over time in the Relugolix-treated group (N=622). Both charts show high baseline levels with rapid decline by week 5, sustained low levels through week 25, and an increase at week 49, the end of treatment safety follow-up.*

FDA Label Image

Figure 2 (Orgovyx 03)

Line graph comparing the mean percent change from baseline in testosterone levels over 49 weeks between Relugolix and Leuprolide. The y-axis represents percent change from baseline, ranging from -100% to 100%, and the x-axis represents time in weeks. Data points show testosterone reduction for both drugs, with patient numbers listed below the timeline.*

FDA Label Image

Figure 3 (Orgovyx 04)

A cumulative incidence curve graph titled 'Cumulative Incidence of Time to Testosterone < 50 ng/dL' comparing relugolix and leuprolide over time in weeks. The y-axis represents cumulative incidence, and the x-axis represents time in weeks up to 49 weeks. Two curves are shown: a solid line for relugolix nearly reaching 1 at approximately 5 weeks, and a dotted line for leuprolide reaching 1 closer to 25 weeks. A table below the graph shows the number of patients at risk for each treatment group across different weeks.*

FDA Label Image

Figure 3 (Orgovyx 05)

A cumulative incidence curve graph showing time to testosterone levels below 20 ng/dL comparing relugolix and leuprolide over 49 weeks. The x-axis represents time in weeks and the y-axis shows cumulative incidence. Patient risk numbers at various weeks are listed below the graph for both relugolix and leuprolide.*

FDA Label Image

Principal Display Panel (120 mg Tablet Bottle Label)

Label for Orgovyx (relugolix) tablets, 120 mg strength, film-coated, oral dosage form. The label indicates a package count of 30 tablets and includes storage instructions to keep at room temperature not above 30°C (86°F). The product is distributed by Myovant Sciences, Inc. and manufactured by Bushu Pharmaceuticals, Ltd. in Japan, with packaging from Germany.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.