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Seysara

(sarecycline)

ApprovedSmall molecule

AAlmirall, S.A.

Seysara is one of 16 small molecule programs targeting Rosacea. It is currently in Approved.

1

Indications

7

Total Trials

0

Active Trials

15

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

4

Patents

Pipeline

Status by Indication[3][1]

Indication

RosaceaCompleted

RosaceaApproved

Completed

Competition

Competitive Landscape

17 competitors in Rosacea

#DrugCompanyPhaseTrials

Vibramycin

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

Alphagan

Minocin

Flagyl

DDePuy Orthopaedics

Avlosulfon

AAlmirall, S.A.

Retin-a

VValeant Pharmaceuticals

Stromectol

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Elavil

Tofranil

Seysara

AAlmirall, S.A.

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

Clinical

Trials by Indication[1]

Effectiveness1 trial

Patient-reported Outcomes for Sarecycline Effectiveness and Safety (PROSES)

Completed·AAlmirall, S.A.··NCT04820673·300 enrolled

Double-blind1 trial

Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne

Completed·AAlmirall, S.A.·Phase 3·NCT02322866·1,034 enrolled

Rosacea1 trial

A Pilot Study on the Use of Seysara for Rosacea

Completed·DDerm Research, PLLC·Phase 4·NCT04555525·100 enrolled

Acne Vulgaris1 trial

A Multi-Center Open-Label Evaluation of the Safety of Sarecycline Tablets in the Treatment of Acne Vulgaris

Completed·AAlmirall, S.A.·Phase 3·NCT02413346·490 enrolled

Ischemic stroke1 trial

Efficacy and Safety of Sarecycline in Patients With Acute Ischemic Stroke After Reperfusion Therapy

Unknown status·—·Phase 2·NCT05836753·120 enrolled

2 more indications

Treatment1 trial

Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne

Completed·AAlmirall, S.A.·Phase 3·NCT02320149·968 enrolled

Safety and Efficacy1 trial

Sarecycline Truncal Acne Safety and Efficacy Response

Completed·AAngela Moore··NCT05010538·10 enrolled

Regulatory

FDA Approval Timeline[4]

Oct 1, 2018

SEYSARA

NDA NDA209521

Sources

References

[1]
ClinicalTrials.gov — 7 trial records for sarecycline. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — sarecycline compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for sarecycline. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA209521). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Seysara. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Almirall, S.A. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: AAlmirall, S.A.

Patent Landscape[5]

Patent Cliff

Aug 10, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9481639Aug 10, 2028

8513223Dec 7, 2029

8318706Jan 3, 2032

9255068Feb 9, 2033

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