| Pharmaceutical Information |
| Drug Name |
Sarecycline |
| Drug ID |
BADD_D02501 |
| Description |
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 [A40005]. After completing various phase-II and phase-III trials demonstrating its effectiveness in treating moderate to severe facial acne vulgaris [A39993, A39994] 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 [L4814]. 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 [L4815].
Acne vulgaris itself is a common chronic skin condition associated with the blockage and/or inflammation of hair follicles and their accompanying sebaceous glands [L4814]. 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 [L4814]. 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 [L4814].
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. |
| Indications and Usage |
Sarecycline is a tetracycline-class drug indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older [FDA Label]. |
| Marketing Status |
Not Available |
| ATC Code |
J01AA14 |
| DrugBank ID |
DB12035
|
| KEGG ID |
D10666
|
| MeSH ID |
C000629276
|
| PubChem ID |
54681908
|
| TTD Drug ID |
D0T6EI
|
| NDC Product Code |
Not Available |
| Synonyms |
sarecycline | (4S,4aS,5aR,12aS)-4-(dimethylamino)-3,10,12,12a-tetrahydroxy-7-((methoxy(methyl)amino)methyl)-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydro-2-tetracenecarboxamide | Seysara |
|
| Chemical Information |
| Molecular Formula |
C24H29N3O8 |
| CAS Registry Number |
1035654-66-0 |
| SMILES |
CN(C)C1C2CC3CC4=C(C=CC(=C4C(=C3C(=O)C2(C(=C(C1=O)C(=O)N)O)O)O)O)CN(C)OC |
| Chemical Structure |
|
|
| ADR Related Proteins Induced by Drug |
| ADR Term |
Protein Name |
UniProt AC |
TTD Target ID |
PMID |
| Not Available | Not Available | Not Available | Not Available | Not Available |
|
| ADRs Induced by Drug |
|
| ADR Term |
ADReCS ID |
ADR Frequency (FAERS)
|
ADR Severity Grade (FAERS)
|
ADR Severity Grade (CTCAE)
|
| Anxiety | 19.06.02.002 | 0.000319% | | | | Dizziness | 24.06.02.007; 17.02.05.003; 02.01.02.004 | 0.000426% | | | | Headache | 17.14.01.001 | 0.000639% | | | | Jaundice | 09.01.01.004; 01.06.04.004; 23.03.03.030 | 0.000213% | | Not Available | | Photosensitivity reaction | 23.03.09.003 | 0.000213% | | | | Rash | 23.03.13.001 | 0.000426% | | Not Available | | Seizure | 17.12.03.001 | 0.000213% | | | | Urticaria | 23.04.02.001; 10.01.06.001 | 0.000213% | | | | Vertigo | 17.02.12.002; 04.04.01.003 | 0.000213% | | | | Vision blurred | 17.17.01.010; 06.02.06.007 | 0.000639% | | | | Decreased appetite | 14.03.01.005; 08.01.09.028 | 0.000213% | | | | Liver injury | 12.01.02.003; 09.01.07.022 | 0.000213% | | Not Available |
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