Pivmecillinam

Overview

Pivmecillinam is a mecillinam prodrug, a pivaloyloxymethyl ester of amdinocillin that is well absorbed orally, but broken down to amdinocillin in the intestinal mucosa. It is active against gram-negative organisms and used as for amdinocillin. [PubChem]

Indication

Used to treat infections due to mecillinam-sensitive organisms such as urinary tract infections, salmonellosis and typhoid fever.

Associated Conditions

Urinary tract infection caused by E. coli
Urinary tract infection caused by enterobacteria
Urinary tract infection caused by klebsiella
Urinary tract infection caused by proteus

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis	2024/11/29	NCT06709196	Phase 4	Recruiting	Rigshospitalet, Denmark
Clinical Trial of Pivmecillinam Hydrochloride Tablets in the Treatment of Uncomplicated Urinary Tract Infection	2022/09/19	NCT05545137	Phase 3	Completed	Benova (Tianjin) Innovative medicine Research Co., Ltd.
Pivmecillinam With Amoxicillin/Clavulanic Acid for Step Down Oral Therapy in ESBL UTIs	2022/02/04	NCT05224401	Phase 3	Recruiting	Lund University
Clinical Effectiveness and Bacteriological Eradication of 4 Short-course Antibiotics for Uncomplicated UTIs in Women.	2021/07/13	NCT04959331	Phase 4	Completed	Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Treating Pyelonephritis an Urosepsis With Pivmecillinam	2017/09/13	NCT03282006	Phase 4	Completed	Sykehuset i Vestfold HF

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
SELEXID	KARO HEALTHCARE AB	02456672	Tablet - Oral	400 MG	N/A
SELEXID	KARO HEALTHCARE AB	02456664	Tablet - Oral	200 MG	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

Alembic Pharmaceuticals Acquires UTILITY Therapeutics to Commercialize First New UTI Antibiotic in 20 Years

3 months ago

Alembic Pharmaceuticals has acquired UTILITY Therapeutics to expand its U.S. commercial portfolio with PIVYA, the first antibiotic approved for uncomplicated urinary tract infections in approximately 20 years.

FDA Approves Blujepa: First Novel Oral Antibiotic for UTIs in Over Two Decades

6 months ago

• The FDA has approved gepotidacin (Blujepa), the first new class of oral antibiotics for urinary tract infections in nearly 30 years, addressing growing concerns about antimicrobial resistance. • Developed by GSK with partial funding from US government agencies, Blujepa works by interfering with bacterial enzymes needed for replication, potentially reducing the likelihood of resistance development. • Clinical trials involving over 3,000 females demonstrated Blujepa's efficacy comparable to or better than nitrofurantoin, with availability expected in the second half of 2025.

FDA Approves Blujepa, First New Class of Oral Antibiotic for UTIs in Nearly 30 Years

6 months ago

GSK's Blujepa (gepotidacin) has received FDA approval for treating uncomplicated urinary tract infections, marking the first new class of oral antibiotics for UTIs in nearly three decades.

FDA Approves Iterum's Orlynvah for Uncomplicated Urinary Tract Infections

a year ago

• The FDA has approved Iterum Therapeutics' Orlynvah (sulopenem etzadroxil and probenecid) for treating adult women with uncomplicated urinary tract infections (uUTIs). • Orlynvah, an oral penem antibiotic, targets infections caused by bacteria like Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis, offering an alternative for those with limited options. • The approval was based on Phase 3 trials (SURE 1 and REASSURE) demonstrating Orlynvah's safety and efficacy compared to ciprofloxacin and Augmentin, respectively. • Iterum Therapeutics aims to commercially launch Orlynvah around mid-2025 and is seeking a strategic transaction to maximize its value.

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