sarecycline hydrochloride

Trade name: seysara

Small moleculeapproved

Approved

Oct 1, 2018

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. 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. — Wikipedia

Clinical trial activity

0 trials · 0 clinical orgs · 2 marketing orgs

Phase 1
0
Phase 2
0
Phase 3
0
Phase 4
0

Timeline

2010s

  1. Oct 1, 2018

    Allergan PLC (2015) — Earliest FDA Approval

  2. Oct 1, 2018

    Almirall — NDA Secondary Org

  3. Oct 1, 2018

    Allergan PLC (2015) — NDA Organization

Indications

Mechanism of action

Approval history

  • approvedOct 1, 2018

Chemistry & pharmacology

Loading structure…

SMILES

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.Cl
Mol. weight
523.97 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • sarecycline hydrochloride

Organizations

Marketing (2)

OrganizationOrg typeRelationshipDate
Allergan PLC (2015)For profitNDAOct 1, 2018
AlmirallFor profitNDA2Oct 1, 2018