This section highlights FDA-related milestones and regulatory updates for drugs developed by Innoviva (INVA).
Over the past two years, Innoviva has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
XACDURO® and Zoliflodacin. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
XACDURO® - FDA Regulatory Timeline and Events
XACDURO® is a drug developed by Innoviva for the following indication: XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use is a combination of sulbactam, a beta-lactam antibacterial, and durlobactam, a beta-lactamase inhibitor.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- XACDURO®
- Announced Date:
- May 20, 2024
- Indication:
- XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use is a combination of sulbactam, a beta-lactam antibacterial, and durlobactam, a beta-lactamase inhibitor
Announcement
Innoviva Specialty Therapeutics and Zai Lab Limited announced that China's National Medical Products Administration (NMPA) has approved Zai Lab's New Drug Application (NDA) for XACDURO® (sulbactam-durlobactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex in patients 18 years of age and older.
AI Summary
Innoviva Specialty Therapeutics and Zai Lab Limited announced that China’s National Medical Products Administration (NMPA) has approved Zai Lab’s New Drug Application (NDA) for XACDURO® (sulbactam-durlobactam). This approval is for treating hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients aged 18 and older, specifically when the infections are caused by susceptible isolates of the Acinetobacter baumannii-calcoaceticus complex.
The decision was based on robust clinical data from the global ATTACK trial, which demonstrated that XACDURO® is both effective and safe compared to current therapies. This approval marks a significant step toward combating drug-resistant Acinetobacter infections, addressing a critical, high unmet medical need in China and beyond.
Read Announcement
Zoliflodacin - FDA Regulatory Timeline and Events
Zoliflodacin is a drug developed by Innoviva for the following indication: For the Treatment of Uncomplicated Gonorrhea.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Zoliflodacin
- Announced Date:
- June 12, 2025
- Estimated Event Date Range:
- December 15, 2025 - December 15, 2025
- Target Action Date:
- December 15, 2025
- Indication:
- For the Treatment of Uncomplicated Gonorrhea
Announcement
Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. announced that The FDA assigned a target action date of December 15, 2025 under the Prescription Drug User-Fee Act (PDUFA).
AI Summary
Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc., announced that the FDA has granted Priority Review for its New Drug Application for zoliflodacin. This investigational antibiotic is designed to treat uncomplicated gonorrhea with a single oral dose. Importantly, the FDA has set a target action date of December 15, 2025 under the Prescription Drug User-Fee Act (PDUFA). The company will be notified about the decision to hold an Advisory Committee Meeting through the Day 74 letter.
If zoliflodacin is approved, it would be the first new antibiotic for gonorrhea in decades. The drug also received a Qualified Infectious Disease Product designation, which may help accelerate its review process and grant extended market exclusivity. This milestone represents an important advancement in the fight against drug-resistant infections.
Read Announcement- Drug:
- Zoliflodacin
- Announced Date:
- June 12, 2025
- Indication:
- For the Treatment of Uncomplicated Gonorrhea
Announcement
Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for zoliflodacin, an investigational first-in-class, single dose, spiropyrimidinetrione oral antibiotic for the treatment of uncomplicated gonorrhea in adults and pediatric patients 12 years and older.
AI Summary
Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for its New Drug Application for zoliflodacin. This investigational, first-in-class oral antibiotic is designed as a single-dose treatment for uncomplicated gonorrhea in adults and pediatric patients aged 12 years and older. The Priority Review designation is intended to expedite the FDA’s evaluation process, with a target action date of December 15, 2025, under the Prescription Drug User-Fee Act.
If approved, zoliflodacin would mark the first new antibiotic for treating gonorrhea in decades—a notable advancement considering the increasing threat of drug-resistant strains. The streamlined, oral administration of zoliflodacin offers a promising alternative to current treatment methods, potentially transforming the therapeutic approach for gonorrhea and addressing critical unmet medical needs.
Read Announcement- Drug:
- Zoliflodacin
- Announced Date:
- June 10, 2025
- Indication:
- For the Treatment of Uncomplicated Gonorrhea
Announcement
Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for zoliflodacin, the investigational first-in-class, single dose, spiropyrimidinetrione oral antibiotic for the treatment of uncomplicated gonorrhea in adults and pediatric patients 12 years and older.
AI Summary
Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc., announced that the U.S. FDA has accepted its New Drug Application (NDA) for zoliflodacin, a first‐in‐class, single-dose, spiropyrimidinetrione oral antibiotic for treating uncomplicated gonorrhea in patients 12 years and older. This potential breakthrough comes at a time when gonorrhea cases are increasingly resistant to existing antibiotics, posing significant public health concerns. If approved, zoliflodacin would be the first new antibiotic to treat gonorrhea in decades, offering a promising new solution for patients, especially those facing infections with multidrug-resistant strains. The FDA’s acceptance of the NDA is based on comprehensive clinical trial data, including pivotal Phase 3 studies that demonstrated the drug’s effectiveness and safety. This milestone sets the stage for potentially providing a more convenient oral treatment option compared to the traditional intramuscular injections currently used.
Read Announcement- Drug:
- Zoliflodacin
- Announced Date:
- April 24, 2024
- Indication:
- For the Treatment of Uncomplicated Gonorrhea
Announcement
Innoviva, Inc. announced that positive results from the Phase 3 oral zoliflodacin trial will be highlighted in an oral presentation given by the Global Antibiotic Research & Development Partnership (GARDP) at the European Society of Clinical Microbiology and Infectious Disease Global Congress (ESCMID Global 2024) taking place April 27-30, 2024, in Barcelona, Spain.
AI Summary
Innoviva, Inc. announced that the promising results from its Phase 3 trial of oral zoliflodacin will be presented by the Global Antibiotic Research & Development Partnership (GARDP). The presentation will occur during the ESCMID Global Congress 2024 in Barcelona, Spain, from April 27-30, 2024. In the trial, zoliflodacin demonstrated a 90.9% microbiological cure rate for uncomplicated gonorrhea, showing statistical non-inferiority compared to the current standard treatment of ceftriaxone and azithromycin. As a first-in-class, single-dose oral antibiotic, zoliflodacin could transform gonorrhea treatment by improving patient compliance and addressing the growing threat of antibiotic resistance. This oral presentation marks an important milestone as Innoviva and GARDP advance the clinical development of zoliflodacin, paving the way for its eventual regulatory submission and potential use as a new treatment option for gonorrhea worldwide.
Read Announcement
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