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Data updated: May 26, 2026

COLESTID (colestipol hydrochloride)

Metabolic Approved 1977-04-04

COLESTID is indicated for the treatment of Hypercholesterolemia; Atherosclerotic Vascular Disease.

Source: FDA Label • Pfizer
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
2
Indications
--
Phase 3 Trials
2
Priority Reviews
49
Years on Market

Details

Status
Prescription
First Approved
1977-04-04
Routes
ORAL
Dosage Forms
GRANULE, TABLET

Companies

Pfizer
Active Ingredient: COLESTIPOL HYDROCHLORIDE

COLESTID Approval History

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Original
New Indication
New Form
Label Update
49 FDA actions from 1977 to 2018
Apr 2018 SUPPL
Label · Labeling
FDA Letter
May 2017 SUPPL
Label · Labeling
FDA Letter Label
May 2014 SUPPL
Label · Labeling
FDA Letter Label

What COLESTID Treats

2 indications

COLESTID is approved for 2 conditions since its original approval in 1977. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypercholesterolemia
  • Atherosclerotic Vascular Disease
Source: FDA Label

COLESTID Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

LEROCHOL
LIB THERAPEUTICS,
2025 2 indic.
PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE
Dr. Reddy's
2024 4 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to COLESTID

3 of 13

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

CHOLESTYRAMINE
CHOLESTYRAMINE
2 shared
ALKEM LABS LTD
Shared indications:
HypercholesterolemiaAtherosclerotic Vascular Disease
CHOLESTYRAMINE LIGHT
CHOLESTYRAMINE
2 shared
PHARMOBEDIENT CNSLTG
Shared indications:
HypercholesterolemiaAtherosclerotic Vascular Disease
COLESTIPOL HYDROCHLORIDE
COLESTIPOL HYDROCHLORIDE
2 shared
IMPAX LABS
Shared indications:
HypercholesterolemiaAtherosclerotic Vascular Disease
View all 13 similar drugs Pro
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

COLESTID FDA Label Details

Indications & Usage

FDA Label (PDF)

COLESTID is indicated for the treatment of Hypercholesterolemia; Atherosclerotic Vascular Disease.

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Data Sources

FDA Approval: NDA017563 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.