Carafate

(Sucralfate)

ApprovedSmall molecule

AbbVie

Carafate is one of 66 small molecule programs targeting GERD. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

GERDCompleted

PneumoniaActive, not recruiting

RefluxWithdrawn

HealingNot yet recruiting

Randomized Controlled TrialNot yet recruiting

GERDPreclinical

Completed

PneumoniaApproved

Active, not recruiting

RefluxPreclinical

Withdrawn

HealingApproved

Not yet recruiting

Randomized Controlled TrialApproved

Not yet recruiting

Competition

Competitive Landscape

155 competitors in Pneumonia

#DrugCompanyPhaseTrials

Carafate

AbbVie

Approved

1 2

Jakafi

Incyte

Preclinical

1 3

Primaquine

Sanofi

Preclinical

1 4

Acanya

Pfizer

Preclinical

1 5

Prevacid

Takeda

Preclinical

1 6

Plaquenil

Jazz Pharmaceuticals

Preclinical

1 7

Innohep

Jazz Pharmaceuticals

Preclinical

1 8

Avlosulfon

AAlmirall, S.A.

Preclinical

4 9

Virazole

CConrado Roberto Hoffmann Filho

Preclinical

2 10

Advil

KKenvue Brands

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Post-ApprovalNot yet recruiting

Healing

NCT07312370

Q4 2027

Post-ApprovalNot yet recruiting

Randomized Controlled Trial

NCT07257926

PreclinicalNot yet recruiting

Healing

NCT07679191

Clinical

Trials by Indication[1]

Healing2 trials

Esomeprazole Plus Sucralfate for Post-ESD Ulcer Healing

Not yet recruiting·LLanZhou University·Phase 4·NCT07312370·120 enrolled

Topical Application of Sucralfate in Promoting Healing of Esophageal Ulcers After Esophageal Varices Ligation: A Randomized Controlled Trial

Not yet recruiting·NNational Cheng-Kung University Hospital·Preclinical·NCT07679191·60 enrolled

Reflux2 trials

Confocal Endomicroscopy for Non-Erosive Reflux Disease (CE NERD)

Withdrawn·VVirginia Commonwealth University·N/A·NCT02039869

Confocal Endomicroscopy for Non-Erosive Reflux Disease Detection

Terminated·LLCMC Health·N/A·NCT02788591·5 enrolled

Prevention2 trials

Colonoscopic Sucralfate Spray in Prevention of Delayed Polypectomy Bleeding

Unknown status·NNational Cheng-Kung University Hospital·Phase 1·NCT05817656·160 enrolled

Prevention of Post-sphincterotomy Bleeding

Recruiting·NNational Cheng-Kung University Hospital·N/A·NCT06107504·120 enrolled

Anal fissure1 trial

Short-Term Outcome of Medical Vs. Surgical Management Of Chronic Anal Fissure

Completed·SSuez Canal University·Phase 1/2·NCT06617026·99 enrolled

Pneumonia1 trial

A Clinico-Bacteriological Study and Effect of Stress Ulcer Prophylaxis on Occurrence of Ventilator Associated Pneumonia

Completed·MMaulana Azad Medical College·Phase 4·NCT00702871·50 enrolled

7 more indications

Eosinophilic Esophagitis1 trial

The Effect of Sucralfate Slurry in Patients With Eosinophilic Esophagitis

Completed·MMayo Clinic·Phase 1·NCT02353078·3 enrolled

Randomized Controlled Trial1 trial

Prevention of Delayed Post-polypectomy Bleeding by Endoscopic Sucralfate Spray in High-risk Patients: A Randomized Controlled Trial

Not yet recruiting·NNational Cheng-Kung University Hospital·Phase 4·NCT07257926·160 enrolled

Oral ulcer1 trial

Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial

Completed·UUniversity of Texas at Austin·Phase 2·NCT03241030·102 enrolled

Effectiveness1 trial

A Comparison of Effectiveness of Oral Sucrolfate, Alginate and Hydrotalcide in Dispeptic Pain Treatment

Completed·PPamukkale University·Phase 4·NCT03635372·300 enrolled

Radiation1 trial

Reducing Acute Upper Gastrointestinal Side-Effects of Thoracic Irradiation

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT05659576·142 enrolled

GERD1 trial

Alginate vs Sucralfate for GERD Symptomatic Relief in Combination With PPIS

Completed·CCMH Lahore Medical College and Institute of Dentistry·Preclinical·NCT07310927·140 enrolled

Unspecified1 trial

Combined Therapy in Radiation Proctopathy

Completed·MMaria Sklodowska-Curie National Research Institute of Oncology·Phase 4·NCT01613534·122 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

CARAFATE

NDA NDA018333

Dec 16, 1993

CARAFATE

NDA NDA019183

Sources

References

[1]
ClinicalTrials.gov — 15 trial records for Sucralfate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Sucralfate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Sucralfate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA019183). U.S. Food & Drug Administration.
[5]
SEC EDGAR — AbbVie company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: AbbVie

Carafate

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Trials by Indication[1]

Healing2 trials

Reflux2 trials

Prevention2 trials

Anal fissure1 trial

Pneumonia1 trial

Eosinophilic Esophagitis1 trial

Randomized Controlled Trial1 trial

Oral ulcer1 trial

Effectiveness1 trial

Radiation1 trial

GERD1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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