Seysara

(sarecycline)

ApprovedSmall molecule

AAlmirall, S.A.

Seysara is one of 61 small molecule programs targeting Rosacea. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

RosaceaActive, not recruiting

Ischemic StrokeActive, not recruiting

RosaceaApproved

Active, not recruiting

Ischemic StrokePhase 2

Active, not recruiting

Competition

Competitive Landscape

430 competitors in Ischemic Stroke

#DrugCompanyPhaseTrials

Seysara

AAlmirall, S.A.

Approved

1 2

Proamatine

Takeda

Preclinical

2 3

Repatha

Amgen

Preclinical

2 4

Levaquin

WWim Janssens

Preclinical

3 5

Tylenol

KKenvue Brands

Preclinical

1 6

Xylocaine

CCitius Pharmaceuticals, Inc.

Preclinical

1 7

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Preclinical

1 8

Statins

Sanofi

Preclinical

1 9

Urokinase

Mmedac GmbH

Preclinical

3 10

Drug Therapy

MMassachusetts General Hospital

Preclinical

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

Clinical

Trials by Indication[1]

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

Treatment1 trial

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

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

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

2 more indications

Safety and Efficacy1 trial

Sarecycline Truncal Acne Safety and Efficacy Response

Completed·AAngela Moore··NCT05010538·10 enrolled

Effectiveness1 trial

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

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

Seysara

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Double-blind1 trial

Treatment1 trial

Ischemic stroke1 trial

Rosacea1 trial

Acne Vulgaris1 trial

Safety and Efficacy1 trial

Effectiveness1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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