Innoviva Specialty Therapeutics*

*a subsidiary of INNOVIVA, Inc.

Performance in the 2026 Benchmark

Strong performance. Innoviva’s sole pipeline candidate, zoliflodacin (NUZOLVENCE®) — which was approved for the treatment of uncomplicated urogenital gonorrhoea after the analysis period concluded — has activity against a ‘high’ priority pathogen (cephalosporin-resistant Neisseria gonorrhoeae) and meets three of four of WHO's innovation criteria. It demonstrates a Best Practice for its innovative candidate and stands out for its robust access and stewardship plan for zoliflodacin, developed in partnership with GARDP. The plan addresses availability, affordability and supply barriers in LMICs, alongside stewardship plans to strengthen AMR surveillance.

Opportunities for Innoviva

Support GARDP with delivery of access plans for zoliflodacin (NUZOLVENCE®). Recently approved for the treatment of uncomplicated urogenital gonorrhoea, zoliflodacin is an antibacterial medicine with activity against resistant strains of N. gonorrhoeae. Through its partnership with the Global Antibiotic Research and Development Partnership (GARDP), it has developed a comprehensive access and stewardship plan for zoliflodacin, under which GARDP holds manufacturing and supply rights for 168 LMICs, representing a comprehensive approach to ensuring global access and responsible use for this innovative antibiotic. After the recent US Food and Drug Administration approval of zoliflodacin, the company can support GARDP to ensure all elements of the access plan are fully realised. 

Sales & Operations

• Therapeutic areas: Anti-infectives, critical care, respiratory diseases 

• Financial stage: Public (IPO completed in October 2004) 

• Products on the market: Giapreza®, NUZOLVENCE®, Xacduro®, Xerava®, Zevtera® 

• Commercial partners: Innoviva commercialises the antibiotic Xacduro® in the US through its subsidiary Entasis Therapeutics, while Pfizer and Zai Lab hold rights in China. Its subsidiary La Jolla Pharmaceutical Company markets the vasoconstrictor Giapreza® and the antibitoic Xerava®. Innoviva also has exclusive US rights to Basilea’s Zevtera®, retains commercial rights to zoliflodacin in major markets (with GARDP covering LMICs and some HICs) and maintains a legacy licensing and royalty partnership with GSK for respiratory drugs. 

• Funding partners: Innoviva has partnered with GARDP to develop the antibiotic zoliflodacin, with GARDP funding its Phase III trial. 

Sample of pipeline assessed by the Benchmark

Pipeline for diseases in scope

Research & Development

One innovative antibacterial medicine targeting a high-priority pathogen. Innoviva has 1 project in its pipeline with activity against pathogens in scope, which was undergoing regulatory review during the period of analysis. Its antibacterial pipeline project, zoliflodacin, indicated for the treatment of uncomplicated urogenital gonorrhea, has demonstrated activity against cephalosporin-resistant Neisseria gonorrhoeae, which is classified as ‘high’ priority on WHO's bacterial priority pathogen list. Zoliflodacin is considered innovative, meeting 3 of WHO’s 4 innovation criteria: it has no known cross-resistance, belongs to a new chemical class and has a new mode of action. In addition, it is administered as a single-dose oral monotherapy, offering a simple alternative to the current injectable regimen for gonorrhoea. Innoviva did not report an active in-house discovery programme.

Comprehensive access and stewardship planning through GARDP partnership. Innoviva has an access plan for its late-stage candidate, zoliflodacin, developed by its partner GARDP. Through a licensing agreement, GARDP holds rights to register and commercialise in over 75% of countries worldwide, including all LICs. A WHO prequalification submission is planned, and a commercialisation agreement includes public-sector access obligations and equitable pricing. Early access is provided via a managed access programme for patients aged 12 years and older with uncomplicated gonorrhoea. GARDP also supports manufacturing scale-up and cost reduction, as well as Innoviva’s stewardship plan for the project. Additionally, Innoviva completed trials in 2 LMICs in scope (South Africa and Thailand) for zoliflodacin. Stewardship is integral to the company’s partnership with GARDP and includes ongoing collaborations with diagnostic companies to strengthen AMR surveillance by developing diagnostic tools and informing responsible clinical use of zoliflodacin.