Doryx

(Doxycycline Hyclate)

ApprovedSmall molecule

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Doryx is one of 131 small molecule programs targeting Duodenal Ulcer. It is currently in Approved.

Indications

Total Trials

Active Trials

130

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Duodenal UlcerActive, not recruiting

RosaceaActive, not recruiting

Hereditary Hemorrhagic TelangiectasiaActive, not recruiting

TendinopathyActive, not recruiting

Oral MucositisActive, not recruiting

Duodenal UlcerApproved

Active, not recruiting

RosaceaPhase 3

Active, not recruiting

Hereditary Hemorrhagic TelangiectasiaPhase 2

Active, not recruiting

TendinopathyPhase 1

Active, not recruiting

Oral MucositisPhase 2

Active, not recruiting

Competition

Competitive Landscape

132 competitors in Oral Mucositis

#DrugCompanyPhaseTrials

Doryx

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

1 2

Afinitor

Novartis

Phase 3

1 3

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

3 4

Cytoxan

BBaxter Healthcare Corporation

Phase 3

2 5

Duragesic

CCephalon

Phase 3

2 6

Neurontin

VViatris Specialty LLC

Phase 3

1 7

Bactroban

PPadagis LLC

Phase 3

1 8

Benadryl

PParkedale

Phase 3

1 9

Curcumin

Merck & Co.

Phase 3

2 10

N-Acetyl Cyteien

SStanford University

Phase 3

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

Timeline

Expected Milestones

Q3 2026

Post-ApprovalActive, not recruiting

Spironolactone

NCT04582383

Q4 2026

N/ARecruiting

Age

NCT05112211

Q2 2027

N/ARecruiting

Prophylaxis

NCT04762134

Clinical

Trials by Indication[1]

Age1 trial

Multi-model Image of Doxycycline in TAO

Recruiting·SSun Yat-sen University·N/A·NCT05112211·20 enrolled

Prophylaxis1 trial

Doxycycline Intervention for Bacterial STI ChemoprOphylaxis (DISCO)

Recruiting·JJonathan Troy Grennan·N/A·NCT04762134·560 enrolled

Oral Mucositis1 trial

Double-blind-randomized,Placebo Controlled Trial for Chemotherapy-associated Oral Mucositis Using Doxycycline Hyclate

Unknown status·—·Phase 2·NCT01087476·164 enrolled

Efficacy and Safety1 trial

A Study to Compare Efficacy and Safety of Trifarotene Cream When Used With an Oral Antibiotic for the Treatment of Severe Acne Vulgaris (AV)

Completed·GGalderma R&D·Phase 4·NCT04451330·202 enrolled

Bone Loss1 trial

Effects of Low-Dose Doxycycline on Oral Bone Loss

Completed·UUniversity of Nebraska·Phase 3·NCT00066027·128 enrolled

12 more indications

Tendinopathy1 trial

Doxycycline for Elbow Tendinopathy

Active, not recruiting·HHospital for Special Surgery, New York·Phase 1·NCT04686799·25 enrolled

Duodenal Ulcer1 trial

The Efficacy and Safety of Ilaprazole/Doxycycline-based Bismuth-containing Quadruple Therapy on Hp Infected Duodenal Ulcers

Completed·TThe Third Xiangya Hospital of Central South University·Phase 4·NCT03342456·184 enrolled

Rosacea1 trial

Determine the Effect of Administering Periostat(R) Twice Daily on Patients With Acne Rosacea

Completed·CCollaGenex Pharmaceuticals·Phase 3·NCT00041977·150 enrolled

Sexually Transmitted Infections1 trial

Evaluation of Doxycycline Post-exposure Prophylaxis to Reduce Sexually Transmitted Infections in PrEP Users and HIV-infected Men Who Have Sex With Men

Completed·UUniversity of California, San Francisco·Phase 4·NCT03980223·641 enrolled

Treatment1 trial

A Treatment for Severe Inflammatory Acne Subjects

Completed·GGalderma R&D·Phase 4·NCT02899000·186 enrolled

Thyroid Associated Ophthalmopathy1 trial

Doxycycline Treatment in Mild Thyroid-Associated Ophthalmopathy

Unknown status·SSun Yat-sen University·Phase 2·NCT02203682·100 enrolled

Acne Vulgaris1 trial

Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate

Completed·WWarner Chilcott·Phase 4·NCT00635609·93 enrolled

Hereditary Hemorrhagic Telangiectasia1 trial

Doxycycline for Hereditary Hemorrhagic Telangiectasia

Completed·UUnity Health Toronto·Phase 2·NCT03397004·13 enrolled

Wet AMD1 trial

MMP-9 Inhibition for Recalcitrant Wet AMD

Unknown status·UUniversity of Iowa·Phase 2·NCT04504123·50 enrolled

Heart Attack1 trial

Doxycycline to Protect Heart Muscle After Heart Attacks

Recruiting·UUniversity of Alberta·Phase 2·NCT03508232·170 enrolled

Acne1 trial

Subantimicrobial Doxycycline in Acne

Completed·MMichigan State University·Phase 4·NCT05399290·22 enrolled

Spironolactone1 trial

Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne

Active, not recruiting·UUniversity of Pennsylvania·Phase 4·NCT04582383·350 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

VIBRAMYCIN

NDA NDA050442

Jan 1, 1982

VIBRAMYCIN

NDA NDA050007

Jan 1, 1982

VIBRA-TABS

NDA NDA050533

Sep 3, 1998

ATRIDOX

NDA NDA050751

Sep 30, 1998

PERIOSTAT

NDA NDA050744

Feb 2, 2001

PERIOSTAT

NDA NDA050783

Aug 13, 2001

DORYX

NDA NDA050582

Jul 25, 2014

ACTICLATE

NDA NDA205931

Dec 19, 2014

DORYX

NDA NDA050795

Apr 26, 2016

ACTICLATE CAP

NDA NDA208253

Jun 15, 2018

LYMEPAK

NDA NDA209844

Sources

References

[1]
ClinicalTrials.gov — 17 trial records for Doxycycline Hyclate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Doxycycline Hyclate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Doxycycline Hyclate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA209844). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Doryx. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Pfizer's Upjohn has merged with Mylan to form Viatris Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Patent Landscape[5]

Patent Cliff

Feb 3, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8715724Feb 3, 2028

9295652Oct 23, 2034

9511031Oct 23, 2034

9446057Dec 23, 2034

Doryx

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q2 2027

Trials by Indication[1]

Age1 trial

Prophylaxis1 trial

Oral Mucositis1 trial

Efficacy and Safety1 trial

Bone Loss1 trial

Tendinopathy1 trial

Duodenal Ulcer1 trial

Rosacea1 trial

Sexually Transmitted Infections1 trial

Treatment1 trial

Thyroid Associated Ophthalmopathy1 trial

Acne Vulgaris1 trial

Hereditary Hemorrhagic Telangiectasia1 trial

Wet AMD1 trial

Heart Attack1 trial

Acne1 trial

Spironolactone1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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