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Pivya

(Pivmecillinam)

ApprovedSmall molecule

AAlembic Pharmaceuticals Ltd.

Pivya is one of 49 small molecule programs targeting Pyelonephritis. It is currently in Approved.

3

Indications

6

Total Trials

4

Active Trials

48

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

PyelonephritisCompleted

Antibiotic ProphylaxisRecruiting

Urinary Tract InfectionRecruiting

PyelonephritisApproved

Completed

Antibiotic ProphylaxisApproved

Recruiting

Urinary Tract InfectionApproved

Recruiting

Competition

Competitive Landscape

39 competitors in Urinary Tract Infection

#DrugCompanyPhaseTrials

Doribax

Cipro

Levaquin

Estrace

Ivadantin

PProcter and Gamble

Voltaren

Vesicare

Invanz

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Monurol

Acanya

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Post-ApprovalRecruiting

Antibiotic Prophylaxis

NCT06709196

Q1 2028

Phase 2Not yet recruiting

Urinary Tract Infections

NCT07871968

Q1 2029

Post-ApprovalRecruiting

Urinary Tract Infection

NCT07236944

Q3 2041

Phase 3Not yet recruiting

Kidney Transplant Infection

NCT07407673

Clinical

Trials by Indication[1]

Effectiveness1 trial

Clinical Effectiveness and Bacteriological Eradication of 4 Short-course Antibiotics for Uncomplicated UTIs in Women.

Completed·FFundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina·Phase 4·NCT04959331·1,000 enrolled

Urinary Tract Infection1 trial

Pivmecillinam as Oral Step-Down Treatment for Escherichia Coli Febrile Urinary Tract Infection Versus Standard of Care

Recruiting·UUppsala University·Phase 4·NCT07236944·560 enrolled

Pyelonephritis1 trial

Treating Pyelonephritis an Urosepsis With Pivmecillinam

Completed·SSykehuset i Vestfold HF·Phase 4·NCT03282006·53 enrolled

Antibiotic Prophylaxis1 trial

Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis

Recruiting·RRigshospitalet, Denmark·Phase 4·NCT06709196·248 enrolled

Kidney Transplant Infection1 trial

Prediction and Prevention of Bloodstream Infections After Kidney Transplantation - The PREDICT Study

Not yet recruiting·SSusanne Dam Nielsen, MD, DMSc·Phase 3·NCT07407673·180 enrolled

1 more indication

Urinary Tract Infections1 trial

Multicenter, Randomized, Open-label, Active-controlled Study With a Blinded Assessor to Evaluate the Safety and Tolerability of Pivmecillinam Hydrochloride Versus Nitrofurantoin for the Treatment of Female Pediatric Subjects, 12 Years to Less Than 18 Years of Age, With Uncomplicated Urinary Tract Infections

Not yet recruiting·AAlembic Pharmaceuticals Ltd.·Phase 2·NCT07871968·100 enrolled

Regulatory

FDA Approval Timeline[4]

Apr 24, 2024

PIVYA

NDA NDA216483

Sources

References

[1]
ClinicalTrials.gov — 6 trial records for Pivmecillinam. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Pivmecillinam compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Pivmecillinam. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA216483). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Alembic Pharmaceuticals Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: AAlembic Pharmaceuticals Ltd.

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