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Sarecycline Hydrochloride
CAS NO.: 1035979-44-2
Chemical Formula: C24H30ClN3O8
Molecular Weight: 524.0000
DMF&GMP status: Please contact us for more details.
Description:
Sarecycline is an oral, once daily, narrow spectrum tetracycline used to treat moderate-to-severe acne. Oral sarecycline use has been rarely linked to serum enzyme elevations during therapy and, although suspected of causing liver injury, it has yet to be linked to clinically apparent acute hepatic injury.

Sarecycline is a semi-synthetic derivative of tetracycline that was initially discovered by Paratek Pharmaceuticals from Boston, MA but then licensed to Warner Chilcott of Rockaway, NJ in July of 2007. After completing various phase-II and phase-III trials demonstrating its effectiveness in treating moderate to severe facial acne vulgaris the US Food and Drug Administration approved Barcelona based Almirall, S.A.'s Seysara (sarecylcine) as a new first in class narrow spectrum tetracycline derived oral antibiotic for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients nine years of age and older. Seysara (sarecycline) was originally part of Allergan's US Medical Dermatology portfolio, before Almirall acquired the portfolio in the second half of 2018 as a means of consolidating and reinforcing the dermatology-focused pharmaceutical company's presence in the United States. Acne vulgaris itself is a common chronic skin condition associated with the blockage and/or inflammation of hair follicles and their accompanying sebaceous glands. The acne often presents physically as a mixture of non-inflammatory and inflammatory lesions mainly on the face but on the back and chest as well. Based upon data from Global Burden of Disease studies, the acne vulgaris condition affects up to 85% of young adults aged 12 to 25 years globally - with the possibility of permanent physical and mental scarring resulting from cases of severe acne. Subsequently, while a number of first line tetracycline therapies like doxycycline and minocycline do exist for treating acne vulgaris, sarecycline presents a new and innovative therapy choice because it exhibits the necessary antibacterial activity against relevant pathogens that cause acne vulgaris but also possesses a low propensity for resistance development in such pathogens and a narrower, more specific spectrum of antibacterial activity, resulting in fewer off-target antibacterial effects on endogenous intestinal flora and consequently fewer resultant adverse effects associated with diarrhea, fungal overgrowth, etc.

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Approvals
Active Ingredient Dosage Form; Route Strength Proprietary Name Applicant
SARECYCLINE HYDROCHLORIDETABLET;ORALEQ 60MG BASESEYSARAALMIRALL LLC
SARECYCLINE HYDROCHLORIDETABLET;ORALEQ 100MG BASESEYSARAALMIRALL LLC
SARECYCLINE HYDROCHLORIDETABLET;ORALEQ 150MG BASESEYSARAALMIRALL LLC
Patent Data
Patent No. Patent Expiration Drug Substance Claim Drug Product Claim Patent Use Code
831870605/01/2031DSDPU-2405
851322312/07/2029U-2406
925506802/09/2033DSDPU-2407 U-2408
948163908/10/2028U-2409
Exclusive Data
Exclusivity Code Exclusivity Expiration
NCE 10/01/2023