Colazal

(Balsalazide)

PreclinicalSmall molecule

VValeant Pharmaceuticals

Colazal is one of 31 small molecule programs targeting Fasting Conditions. It is currently in Preclinical.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Fasting ConditionsCompleted

Fasting ConditionsPreclinical

Completed

Competition

Competitive Landscape

35 competitors in Fasting Conditions

#DrugCompanyPhaseTrials

Dynastat

Pfizer

Phase 3

1 2

Flomax

Sanofi

Phase 1

2 3

Jardiance

Boehringer Ingelheim

Phase 1

4 4

Lamisil

Novartis

Preclinical

1 5

Monopril

Bristol-Myers Squibb

Preclinical

1 6

Ambien

PPurdue Pharma LP

Preclinical

4 7

Jardiance

Boehringer Ingelheim

Phase 1

1 8

Anjeso

Boehringer Ingelheim

Preclinical

3 9

Isopto Carpine

AAdvanz Pharma

Preclinical

2 10

Plendil

AstraZeneca

Preclinical

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

Clinical

Trials by Indication[1]

Fasting Conditions2 trials

A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Balsalazide Disodium 750 mg Capsules Under Fasting Conditions

Completed·RRoxane Laboratories·N/A·NCT00618202·52 enrolled

Bioequivalency Study of Balsalazide Capsules Under Fasting Conditions

Completed·RRoxane Laboratories·N/A·NCT00618228·52 enrolled

Regulatory

FDA Approval Timeline[4]

Jul 18, 2000

COLAZAL

NDA NDA020610

Feb 3, 2012

GIAZO

NDA NDA022205

Sources

References

[1]
ClinicalTrials.gov — 2 trial records for Balsalazide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Balsalazide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Balsalazide. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA022205). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Colazal. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Valeant Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Preclinical[1]
Company: VValeant Pharmaceuticals

Patent Landscape[5]

Patent Cliff

Feb 24, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9192616Aug 2, 2026

7625884Aug 24, 2026

7452872Aug 24, 2026

7452872*PEDFeb 24, 2027

7625884*PEDFeb 24, 2027

1 more patents

8497256Jun 23, 2031

Colazal

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Fasting Conditions2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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