Sarecycline - PharmaKB

Sarecycline

Seysara (sarecycline) is a small molecule pharmaceutical. Sarecycline was first approved as Seysara on 2018-10-01. It is used to treat acne vulgaris in the USA.

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Clinical

Drug

Target

Variants

Financial

Trends

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Events Timeline

YTD

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
skin and connective tissue diseases	D017437

Trade Name

FDA

EMA

Seysara

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Sarecycline hydrochloride

Tradename	Company	Number	Date	Products
SEYSARA	Almirall	N-209521 RX	2018-10-01	3 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
seysara	New Drug Application	2024-06-05

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
acne vulgaris	EFO_0003894	D000152	L70

Agency Specific

FDA

EMA

No data

Patent Expiration

Patent	Expires	Flag	FDA Information
Sarecycline Hydrochloride, Seysara, Almirall
9255068	2033-02-09	DS, DP	U-2407, U-2408
8318706	2031-05-01	DS, DP	U-2405
8513223	2029-12-07		U-2406
9481639	2028-08-10		U-2409

ATC Codes

J: Antiinfectives for systemic use

— J01: Antibacterials for systemic use

— J01A: Tetracycline antibiotics

— J01AA: Tetracyclines

— J01AA14: Sarecycline

HCPCS

No data

Clinical

Clinical Trials

9 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Rosacea	D012393	—	L71	—	—	—	1	—	1
Perioral dermatitis	D019557	EFO_1001305	L71.0	—	—	—	1	—	1
Dermatitis	D003872	—	L30.9	—	—	—	1	—	1

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Acne vulgaris	D000152	EFO_0003894	L70	—	1	3	—	2	6

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Ischemic stroke	D000083242	—	—	—	1	—	—	—	1
Stroke	D020521	EFO_0000712	I63.9	—	1	—	—	—	1
Ischemia	D007511	EFO_0000556	—	—	1	—	—	—	1
Cerebral infarction	D002544	—	I63	—	1	—	—	—	1

Indications Phases 1

No data

Indications Without Phase

No data

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Sarecycline
INN	sarecycline
Description	Sarecycline, sold under the brand name Seysara, is a narrow-spectrum tetracycline-derived antibiotic medication. It is specifically designed for the treatment of acne, and was approved by the FDA in October 2018 for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. Two randomized and well-controlled clinical trials reported efficacy data on both facial and truncal acne (back and chest). Efficacy was assessed in a total of 2002 subjects 9 years of age and older. Unlike other tetracycline-class antibiotics, sarecycline has a long C7 moiety that extends into and directly interact with the bacterial messenger RNA (mRNA). The spectrum of activity is limited to clinically relevant Gram-positive bacteria, mainly Cutibacterium acnes, with little or no activity against Gram-negative bacterial microflora commonly found in the human gastrointestinal tract.
Classification	Small molecule
Drug class	antibiotics (tetracycline derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CON(C)Cc1ccc(O)c2c1C[C@H]1C[C@H]3[C@H](N(C)C)C(O)=C(C(N)=O)C(=O)[C@@]3(O)C(O)=C1C2=O