RHB-104 — Competitive Intelligence Brief

RHB-104 (RHB-104) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Antibiotic combination. Area: Gastroenterology / Immunology.

phase 3 Antibiotic combination Mycobacterium avium subspecies paratuberculosis (MAP) Gastroenterology / Immunology Small molecule

Target snapshot

RHB-104 (RHB-104) — RedHill Biopharma Limited. RHB-104 is a combination of three antibiotics (clarithromycin, rifabutin, and clofazimine) designed to target Mycobacterium avium subspecies paratuberculosis (MAP) in Crohn's disease.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
RHB-104 TARGET	RHB-104	RedHill Biopharma Limited	phase 3	Antibiotic combination	Mycobacterium avium subspecies paratuberculosis (MAP)
omeprazole plus amoxicillin	omeprazole plus amoxicillin	National Taiwan University Hospital	marketed	Proton pump inhibitor + beta-lactam antibiotic combination	Proton pump (H+/K+-ATPase) and bacterial cell wall (penicillin-binding proteins)
Colistin/Polymyxin B + Meropenem	Colistin/Polymyxin B + Meropenem	National University of Singapore	marketed	Antibiotic combination (polymyxin + carbapenem)	Bacterial cell membrane (polymyxins) and bacterial cell wall/penicillin-binding proteins (meropenem)
Cefazolin + Gentamicin	Cefazolin + Gentamicin	Mercy Health Ohio	marketed	Beta-lactam antibiotic + aminoglycoside antibiotic combination	Bacterial penicillin-binding proteins (cefazolin); bacterial 30S ribosomal subunit (gentamicin)
Intranasal Mupirocin and Topical Chlorhexidine	Intranasal Mupirocin and Topical Chlorhexidine	University of Maryland, Baltimore	marketed	Topical antibiotic combination	Bacterial isoleucyl-tRNA synthetase (mupirocin); bacterial cell membrane and proteins (chlorhexidine)
Vonoprazan + amoxicillin + clarithromycin	Vonoprazan + amoxicillin + clarithromycin	The Third Xiangya Hospital of Central South University	marketed	Proton pump inhibitor + antibiotic combination	H+ K+-ATPase (vonoprazan); bacterial cell wall and protein synthesis (amoxicillin and clarithromycin)
Ilaprazole + Amoxicillin	Ilaprazole + Amoxicillin	Il-Yang Pharm. Co., Ltd.	marketed	Proton pump inhibitor + Beta-lactam antibiotic combination	H+/K+-ATPase (ilaprazole); Bacterial cell wall peptidoglycan (amoxicillin)

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 (Antibiotic combination class)

1. Michael E. DeBakey VA Medical Center · 2 drugs in this class
2. University of South Florida · 2 drugs in this class
3. Halmstad County Hospital · 1 drug in this class
4. Hospital General Universitario Elche · 1 drug in this class
5. Hospital de Clinicas de Porto Alegre · 1 drug in this class
6. McMaster University · 1 drug in this class
7. Assistance Publique - Hôpitaux de Paris · 1 drug in this class
8. Shanghai Jiao Tong University School of Medicine · 1 drug in this class
9. The Cleveland Clinic · 1 drug in this class
10. The Forsyth Institute · 1 drug in this class