PAR-101/OPT-80 — Competitive Intelligence Brief

PAR-101/OPT-80 (PAR-101/OPT-80) competitive landscape: 3 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Non-systemic antibiotic; bacterial RNA polymerase inhibitor. Area: Infectious Disease.

phase 3 Non-systemic antibiotic; bacterial RNA polymerase inhibitor Bacterial RNA polymerase (C. difficile) Infectious Disease Small molecule

Target snapshot

PAR-101/OPT-80 (PAR-101/OPT-80) — Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). PAR-101/OPT-80 is a non-systemic antibiotic that binds to bacterial RNA polymerase to inhibit Clostridioides difficile growth in the colon.

Comparator set (3 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
PAR-101/OPT-80 TARGET	PAR-101/OPT-80	Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	phase 3	Non-systemic antibiotic; bacterial RNA polymerase inhibitor	Bacterial RNA polymerase (C. difficile)
Placebo matched to Rifampin	Placebo matched to Rifampin	Hamilton Health Sciences Corporation	phase 3	Bacterial RNA polymerase inhibitor	Bacterial RNA polymerase
Rifampin containing regimen	Rifampin containing regimen	Nantes University Hospital	phase 3	Bacterial RNA polymerase inhibitor	bacterial RNA polymerase beta subunit
Standard dose rifampicin	Standard dose rifampicin	Radboud University Medical Center	phase 3	Bacterial RNA polymerase inhibitor	beta subunit of bacterial RNA polymerase

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Non-systemic antibiotic; bacterial RNA polymerase inhibitor class)

1. Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · 1 drug in this class