What is the new antibiotic in 2025? A Look at Recent Approvals & The Drug Pipeline

October 6, 2025 •

3 min read

Antimicrobial resistance (AMR) contributed to over a million deaths worldwide in 2021, underscoring the urgent need for novel treatments. So, what is the new antibiotic in 2025 that offers hope against these superbugs? Several important approvals and pipeline developments mark the year.

Quick Summary

An overview of significant new antibiotics in 2025. This summary details recently FDA-approved drugs, including Gepotidacin and Emblaveo, and examines promising candidates like Zosurabalpin and Clovibactin that are advancing through clinical trials.

Key Points

Gepotidacin (Blujepa) Approved: In March 2025, the FDA approved Gepotidacin, the first new oral antibiotic class for uncomplicated UTIs in nearly 30 years.
Emblaveo (aztreonam-avibactam) Approved: In February 2025, the FDA approved Emblaveo for treating complicated intra-abdominal infections caused by resistant Gram-negative bacteria.
Zosurabalpin Enters Phase 3: Roche is advancing Zosurabalpin into phase 3 trials to target the critical-threat pathogen Carbapenem-Resistant Acinetobacter baumannii (CRAB).
Clovibactin's Novel Mechanism: Clovibactin, an earlier-stage candidate, shows promise by targeting multiple bacterial cell wall precursors, making resistance development difficult.
Tackling Common Infections: Gepotidacin provides a new oral option for uncomplicated UTIs, which affect millions of women annually and face rising resistance.
Fighting Critical Threats: Emblaveo and Zosurabalpin are specifically designed to combat some of the most dangerous, hospital-acquired superbugs.
Policy Push: The PASTEUR Act has been proposed to create a subscription model to incentivize antibiotic development by delinking profit from sales volume.

The Growing Threat of Antimicrobial Resistance (AMR)

Antimicrobial resistance (AMR) is one of the most significant public health challenges of the 21st century. It occurs when bacteria, viruses, fungi, and parasites evolve to no longer respond to medicines, making infections harder to treat and increasing the risk of disease spread, severe illness, and death. The U.S. Centers for Disease Control and Prevention (CDC) has classified several pathogens as urgent threats, including Carbapenem-Resistant Acinetobacter baumannii (CRAB) and Carbapenem-Resistant Enterobacterales (CRE). For years, the pipeline for new antibiotics has been insufficient to combat the rise of these 'superbugs', primarily due to market failures and the high cost of development. However, 2025 has seen crucial progress with new approvals and promising late-stage candidates.

Newly Approved Antibiotics in 2025

Gepotidacin (Blujepa): A New Class for a Common Infection

In March 2025, the U.S. Food and Drug Administration (FDA) approved Gepotidacin, marketed as Blujepa. This marks the first approval of a new class of oral antibiotics for uncomplicated urinary tract infections (uUTIs) in nearly three decades. Developed by GSK, Gepotidacin is a triazaacenaphthylene antibiotic. It inhibits two bacterial enzymes, DNA gyrase and topoisomerase IV, essential for replication. Clinical trials showed efficacy comparable or superior to nitrofurantoin. It is approved for women and adolescents aged 12 and older.

Emblaveo (aztreonam-avibactam): Targeting Resistant Gram-Negative Infections

In February 2025, the FDA approved Emblaveo, a combination of aztreonam and avibactam, for treating complex intra-abdominal infections in adults with limited or no other treatment options. This intravenous antibiotic is effective against multidrug-resistant Gram-negative bacteria, including those producing metallo-β-lactamases (MBLs). Emblaveo combines aztreonam, which targets bacterial cell wall synthesis, with avibactam, a β-lactamase inhibitor. The REVISIT trial demonstrated a cure rate similar to meropenem. Availability is expected in the latter half of 2025.


New Antibiotic (2025)	Brand Name	Mechanism of Action	Primary Indication	Developer / Sponsor
Gepotidacin	Blujepa	Inhibits bacterial DNA gyrase and topoisomerase IV.	Uncomplicated Urinary Tract Infections (uUTIs).	GSK.
Aztreonam-avibactam	Emblaveo	Inhibits bacterial cell wall synthesis and protects from β-lactamase degradation.	Complicated Intra-Abdominal Infections (cIAI).	Abbvie.
Tebipenem HBr	(TBD)	Oral carbapenem; inhibits bacterial cell wall synthesis.	Complicated Urinary Tract Infections (cUTI).	GSK / Spero Therapeutics.

Promising Antibiotics in the Pipeline

Zosurabalpin: A Hope Against CRAB

Zosurabalpin, developed by Roche, targets Carbapenem-Resistant Acinetobacter baumannii (CRAB), a critical priority pathogen. In May 2025, Roche advanced Zosurabalpin to phase 3 trials. This could be the first new class of drug for Gram-negative infections in over 50 years. Zosurabalpin blocks lipopolysaccharide (LPS) transport, vital for bacterial survival. Phase 3 trials are anticipated in late 2025 or early 2026.

Clovibactin: A Resistance-Resistant Discovery

Clovibactin, an experimental antibiotic from soil bacteria, shows promise against resistance. It targets multiple bacterial cell wall precursors and self-assembles on the bacterial membrane to kill cells. This multi-target mechanism makes resistance development challenging. It is effective against Gram-positive pathogens like MRSA. While early stage, it represents a significant advance.

Addressing the Development Challenge

Legislation like the PASTEUR Act has been introduced in the U.S. to address the slow pace of antibiotic development. It proposes a subscription-style payment model to incentivize R&D for new, critical antibiotics by delinking profit from sales volume.

Conclusion

2025 has been a significant year in the fight against AMR with the FDA approvals of Gepotidacin and Emblaveo. Promising candidates like Zosurabalpin and Clovibactin offer future hope. Combined with policy initiatives, these developments show renewed momentum against superbugs.

Authoritative Link: For more information on antimicrobial resistance, visit the World Health Organization (WHO).

Frequently Asked Questions

As of September 2025, two significant new antibiotics approved by the FDA are Gepotidacin (Blujepa) for urinary tract infections and Emblaveo (aztreonam-avibactam) for complicated intra-abdominal infections.

Gepotidacin is the first oral antibiotic from a new drug class approved for uncomplicated urinary tract infections (uUTIs) in almost 30 years. It uses a novel dual-target mechanism to inhibit bacterial replication.

Emblaveo is designed to treat serious infections caused by multidrug-resistant Gram-negative bacteria, including those that produce enzymes like metallo-β-lactamases (MBLs) which make many other antibiotics ineffective.

No, as of late 2025, Zosurabalpin is not yet publicly available. It is being advanced into phase 3 clinical trials, which are the final stage of testing before a drug can be submitted for FDA approval.

Clovibactin attacks the bacterial cell wall by binding to three different essential precursor molecules simultaneously. This multi-target approach makes it extremely difficult for bacteria to mutate and develop resistance.

A 'superbug' is a common term for strains of bacteria that are resistant to multiple types of antibiotics. Infections caused by these bacteria, such as CRAB and CRE, are very difficult to treat.

The PASTEUR Act is a proposed U.S. law designed to fix the broken market for antibiotic development. It would create a subscription model where the government pays a fixed fee for access to new critical antibiotics, encouraging innovation without relying on high sales volume.