Pivya

(Pivmecillinam)

ApprovedSmall molecule

AAlembic Pharmaceuticals Ltd.

Pivya is one of 84 small molecule programs targeting Pyelonephritis. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

PyelonephritisActive, not recruiting

Kidney TransplantActive, not recruiting

Urinary Tract InfectionActive, not recruiting

PyelonephritisApproved

Active, not recruiting

Kidney TransplantPhase 2

Active, not recruiting

Urinary Tract InfectionApproved

Active, not recruiting

Competition

Competitive Landscape

476 competitors in Kidney Transplant

#DrugCompanyPhaseTrials

Pivya

AAlembic Pharmaceuticals Ltd.

Approved

1 2

Nulojix

Bristol-Myers Squibb

Preclinical

16 3

Simulect

Novartis

Preclinical

15 4

Medrol

Pfizer

Preclinical

12 5

Zinbryta

Roche

Preclinical

6 6

Zemplar

AbbVie

Preclinical

2 7

Sensipar

Amgen

Preclinical

1 8

Epogen

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Preclinical

1 9

Radicava

Shionogi

Preclinical

1 10

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

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

Timeline

Expected Milestones

Q1 2027

Post-ApprovalRecruiting

Antibiotic Prophylaxis

NCT06709196

Q1 2029

Post-ApprovalRecruiting

Urinary Tract Infection

NCT07236944

Q3 2029

Phase 2Not yet recruiting

Kidney Transplant

NCT07407673

Clinical

Trials by Indication[1]

Kidney Transplant1 trial

Prediction and Prevention of Bloodstream Infections After Kidney Transplantation

Not yet recruiting·SSusanne Dam Nielsen, MD, DMSc·Phase 2·NCT07407673·150 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

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

Regulatory

FDA Approval Timeline[4]

Apr 24, 2024

PIVYA

NDA NDA216483

Sources

References

[1]
ClinicalTrials.gov — 5 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.

Pivya

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q1 2029

Q3 2029

Trials by Indication[1]

Kidney Transplant1 trial

Antibiotic Prophylaxis1 trial

Effectiveness1 trial

Urinary Tract Infection1 trial

Pyelonephritis1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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