Bafiertam

(L-N-monomethyl arginine acetate (L-NMMA))

Phase 2Small molecule

GSK

Bafiertam is one of 34 small molecule programs targeting Chronic Kidney Disease. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Chronic Kidney DiseaseActive, not recruiting

Chronic Kidney DiseasePhase 2

Active, not recruiting

Competition

Competitive Landscape

540 competitors in Chronic Kidney Disease

#DrugCompanyPhaseTrials

Aranesp

Amgen

Preclinical

40 2

Epogen

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

Preclinical

16 3

Uloric

Takeda

Preclinical

3 4

Lorelco

Sanofi

Preclinical

1 5

Sovaldi

Gilead

Preclinical

1 6

Bafiertam

GSK

Phase 2

1 7

Activase

Flomax

Miochol

BBausch Health Americas, Inc.

Preclinical

2 10

Genotropin

EMD Serono

Preclinical

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

Clinical

Trials by Indication[1]

Chronic Kidney Disease1 trial

Anemia Study in Chronic Kidney Disease (CKD) : Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat -Forearm Blood Flow (ASCEND-FBF)

Terminated· GSK logo

GSK·Phase 2·NCT03446612·6 enrolled

Regulatory

FDA Approval Timeline[4]

Apr 28, 2020

BAFIERTAM

NDA NDA210296

Sources

References

[1]
ClinicalTrials.gov — 1 trial record for L-N-monomethyl arginine acetate (L-NMMA). U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — L-N-monomethyl arginine acetate (L-NMMA) compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for L-N-monomethyl arginine acetate (L-NMMA). EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA210296). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Bafiertam. U.S. Food & Drug Administration.
[6]
SEC EDGAR — GSK company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: GSK

Patent Landscape[5]

Patent Cliff

Feb 27, 2035

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11903918Feb 27, 2035

10918615Feb 27, 2035

10918616Feb 27, 2035

11590095Feb 27, 2035

9511043Feb 27, 2035

16 more patents

9326965Feb 27, 2035

9814692Feb 27, 2035

9636318Feb 27, 2035

9814691Feb 27, 2035

10105336Feb 27, 2035

9820961Feb 27, 2035

10098863Feb 27, 2035

9517209Feb 27, 2035

9566259Feb 27, 2035

9326947Feb 27, 2035

10105335Feb 27, 2035

10105337Feb 27, 2035

10918617Feb 27, 2035

9636319Feb 27, 2035

10945985Feb 27, 2035

9820960Feb 27, 2035

Bafiertam

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Chronic Kidney Disease1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Related News