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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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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Seysara
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Sarecycline hydrochloride
Tradename
Company
Number
Date
Products
SEYSARAAlmirallN-209521 RX2018-10-01
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
seysaraNew Drug Application2020-03-25
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
acne vulgarisEFO_0003894D000152L70
Agency Specific
FDA
EMA
Expiration
Code
SARECYCLINE HYDROCHLORIDE, SEYSARA, ALMIRALL
2023-10-01NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Sarecycline Hydrochloride, Seysara, Almirall
92550682033-02-09DS, DPU-2407, U-2408
83187062031-05-01DS, DPU-2405
85132232029-12-07U-2406
94816392028-08-10U-2409
ATC Codes
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01A: Tetracycline antibiotics
— J01AA: Tetracyclines
— J01AA14: Sarecycline
HCPCS
No data
Clinical
Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
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 nameSARECYCLINE
INNsarecycline
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 classantibiotics (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
Identifiers
PDB—
CAS-ID1035654-66-0
RxCUI—
ChEMBL IDCHEMBL2364632
ChEBI ID—
PubChem CID54681908
DrugBankDB12035
UNII ID94O110CX2E (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 108 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
0 adverse events reported
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