Cystadrops

(Cysteamine)

Phase 3Small molecule

LLeadiant Biosciences, Inc.

Cystadrops is one of 112 small molecule programs targeting Cystinosis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

111

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

CystinosisActive, not recruiting

PneumoniaActive, not recruiting

Non-Alcoholic SteatohepatitisActive, not recruiting

Cystic FibrosisActive, not recruiting

CystinosisPreclinical

Active, not recruiting

PneumoniaPhase 3

Active, not recruiting

Non-Alcoholic SteatohepatitisPhase 1/Phase 2

Active, not recruiting

Cystic FibrosisPhase 2

Active, not recruiting

Competition

Competitive Landscape

547 competitors in Pneumonia

#DrugCompanyPhaseTrials

Cystadrops

LLeadiant Biosciences, Inc.

Phase 3

1 2

Jakafi

Incyte

Preclinical

1 3

Retrovir

BBp Consulting, Inc

Preclinical

2 4

Primsol

CConrado Roberto Hoffmann Filho

Preclinical

2 5

Virazole

CConrado Roberto Hoffmann Filho

Preclinical

2 6

Alka-Seltzer

AAbbott

Preclinical

1 7

Tylenol

KKenvue Brands

Preclinical

1 8

Prograf

VVeloxis Pharmaceuticals

Preclinical

1 9

Nexium

DDexcel Pharma Technologies Ltd.

Preclinical

1 10

Tagamet

DDT MedTech, LLC

Preclinical

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

Timeline

Expected Milestones

Q1 2028

Phase 3Recruiting

Pneumonia

NCT02735707

Clinical

Trials by Indication[1]

Cystinosis3 trials

New Cysteamine Eye Drops Formulation to Treat Corneal Crystals in Cystinosis

Completed·NNational Eye Institute (NEI)·Phase 1·NCT00001736·51 enrolled

Cysteamine Eye Drops to Treat Corneal Crystals in Cystinosis

Completed·NNational Eye Institute (NEI)·Phase 2·NCT00001213·328 enrolled

Use of Cysteamine in the Treatment of Cystinosis

Recruiting·NNational Human Genome Research Institute (NHGRI)··NCT00359684·330 enrolled

Cystic Fibrosis2 trials

First Study of Oral Cysteamine in Cystic Fibrosis

Completed·UUniversity of Aberdeen·Phase 1/2·NCT02212431·10 enrolled

A Study of the Dosing, Efficacy, and Safety of Oral Cysteamine in Adult Patients With Cystic Fibrosis Exacerbations

Completed·NNovaBiotics Ltd.·Phase 2·NCT03000348·91 enrolled

Pneumonia1 trial

Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia

Recruiting·UUMC Utrecht·Phase 3·NCT02735707·20,000 enrolled

Non-Alcoholic Steatohepatitis1 trial

A Preliminary Study to Evaluate Cysteamine Therapy in Human Subjects With Non-Alcoholic Steatohepatitis (NASH)

Completed·JJoel Lavine·Phase 1/2·NCT00799578·13 enrolled

Effectiveness1 trial

Effectiveness of a Bilayering Serum and Cream Containing GABA, DMAE, Cysteamine, and Bakuchiol for Skin Whitening and Anti-Aging

Completed·HHasanuddin University·Phase 2·NCT07477288·44 enrolled

3 more indications

Efficacy1 trial

Efficacy of Topical Cysteamine in Nephropathic Cyctinosis

Completed·TThe Eye Center and The Eye Foundation for Research in Ophthalmology·N/A·NCT02766855·26 enrolled

Treatment1 trial

A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease

Completed·MMylan Laboratories·Phase 2·NCT00002110·300 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Topical Cysteamine for Postinflammatory Hyperpigmentation

Unknown status·—·N/A·NCT05206318·40 enrolled

Regulatory

FDA Approval Timeline[4]

Oct 2, 2012

CYSTARAN

NDA NDA200740

Aug 19, 2020

CYSTADROPS

NDA NDA211302

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for Cysteamine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Cysteamine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Cysteamine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA211302). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Leadiant Biosciences, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: LLeadiant Biosciences, Inc.

Cystadrops

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2028

Trials by Indication[1]

Cystinosis3 trials

Cystic Fibrosis2 trials

Pneumonia1 trial

Non-Alcoholic Steatohepatitis1 trial

Effectiveness1 trial

Efficacy1 trial

Treatment1 trial

Efficacy and Safety1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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