Innoviva Gets FDA Approval for Gonorrhea Drug

Dow Jones

2025/12/13

By Katherine Hamilton

Innoviva received approval from the Food and Drug Administration for Nuzolvence, a treatment of gonorrhea.

Nuzolvence has been approved as a single-dose oral medication to treat uncomplicated urogenital gonorrhea in patients 12 years and older, the biopharmaceutical company said Friday.

Innoviva plans to commercialize the drug in the second half of 2026, either in collaboration with a commercialization partner or independently.

The approval comes after Nuzolvence demonstrated non-inferiority compared with other treatments in a phase 3 trial of 930 patients.

Gonorrhea is the second-most common sexually transmitted bacterial infection in the world, with more than 82 million new cases a year, according to the company. Without timely treatment, it can lead to serious and potentially permanent health complications.

Write to Katherine Hamilton at katherine.hamilton@wsj.com

(END) Dow Jones Newswires

December 12, 2025 17:14 ET (22:14 GMT)

Copyright (c) 2025 Dow Jones & Company, Inc.

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Without timely treatment, it can lead to serious and potentially permanent health complications. \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  Write to Katherine Hamilton at katherine.hamilton@wsj.com \n</p>\n<p>\n  (END) Dow Jones Newswires\n</p>\n<p>\n  December 12, 2025 17:14 ET (22:14 GMT)\n</p>\n<p>\n  Copyright (c) 2025 Dow Jones &amp; Company, Inc.\n</p>\n</font>","source":null,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Innoviva Gets FDA Approval for Gonorrhea Drug</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 12.5px; color: #7E829C; margin: 0;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nInnoviva Gets FDA Approval for Gonorrhea Drug\n</h2>\n<h4 class=\"meta\">\n<div class=\"head\" \">\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/150f88aa4d182df19190059f4a365e99);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Dow Jones </p>\n<p class=\"h-time smaller\">2025-12-13 06:14</p>\n</div>\n</div>\n</h4>\n</header>\n<article>\n<font class=\"NormalMinus1\" face=\"Arial\">\n<p>\n  By Katherine Hamilton \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  Innoviva received approval from the Food and Drug Administration for Nuzolvence, a treatment of gonorrhea. \n</p>\n<p>\n  Nuzolvence has been approved as a single-dose oral medication to treat uncomplicated urogenital gonorrhea in patients 12 years and older, the biopharmaceutical company said Friday. \n</p>\n<p>\n  Innoviva plans to commercialize the drug in the second half of 2026, either in collaboration with a commercialization partner or independently. \n</p>\n<p>\n  The approval comes after Nuzolvence demonstrated non-inferiority compared with other treatments in a phase 3 trial of 930 patients. \n</p>\n<p>\n  Gonorrhea is the second-most common sexually transmitted bacterial infection in the world, with more than 82 million new cases a year, according to the company. Without timely treatment, it can lead to serious and potentially permanent health complications. \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  Write to Katherine Hamilton at katherine.hamilton@wsj.com \n</p>\n<p>\n  (END) Dow Jones Newswires\n</p>\n<p>\n  December 12, 2025 17:14 ET (22:14 GMT)\n</p>\n<p>\n  Copyright (c) 2025 Dow Jones &amp; Company, Inc.\n</p>\n</font>\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"INVA","symbol_name":"Innoviva, Inc.","start_time":0,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","article_id":"2591684101","we_media_id":"106","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2591684101","pubTimestamp":1765577640,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Dow Jones","introduction":"Dow Jones publishes the world’s most trusted business news and financial information in a variety of media.","home_visible":0,"id":"106","head_image":"https://static.tigerbbs.com/150f88aa4d182df19190059f4a365e99"},"summary":"Innoviva received approval from the Food and Drug Administration for Nuzolvence, a treatment of gonorrhea.Nuzolvence has been approved as a single-dose oral medication to treat uncomplicated urogenital gonorrhea in patients 12 years and older, the biopharmaceutical company said Friday.Innoviva plans to commercialize the drug in the second half of 2026, either in collaboration with a commercialization partner or independently.The approval comes after Nuzolvence demonstrated non-inferiority compared with other treatments in a phase 3 trial of 930 patients.Gonorrhea is the second-most common sexually transmitted bacterial infection in the world, with more than 82 million new cases a year, according to the company. 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