Drugs / Sarecycline
Sarecycline
also known as
P-00562 · P-005672 · PO-05672 · Sareciclina · SARECYCLINE HYDROCHLORIDE · Seysara · WC-3035
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed acne 2 milestones | |||||
| Filed | US (FDA) | Seysara | acne | 2018-02-06 | “the FDA has accepted a New Drug Application (NDA) for Seysara™ (sarecycline) for the treatment of moderate to severe acne vulgaris” abbvie.com ↗ |
| Filed | China (NMPA) | Seysara | acne | — | “Seysara ® (sarecycline), the phase III clinical study conducted in China met primary and key secondary endpoints and Almirall has submitted a dossier with the Chinese National...” almirall.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | SEYSARA | — | 2018-10-01 | fda.gov ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 33 trials · 2 met primary | ||||||
| Phase 3 | NCT02413346 | Mar 2015 → Aug 2016 | acne | Almirall, S.A. | Completed | No outcome recorded |
| Phase 3 | NCT02320149 | Dec 2014 → Feb 2017 | acne | Almirall, S.A. | Completed | Met primary |
| Phase 3 | NCT02322866 | Dec 2014 → Jan 2017 | acne | Almirall, S.A. | Completed | Met primary |
| Phase 43 trials | ||||||
| Phase 4 | NCT07544251 | Apr 2026 → Apr 2027 expected | acne | Integrative Skin Science and Research | Recruiting | No outcome recorded |
| Phase 4 | NCT06461299 | Jul 2023 → Mar 2024 | acneiform dermatitis | The Dermatology Institute of Boston | Completed | No outcome recorded |
| Phase 4 | NCT04555525 | Apr 2019 → Sep 2020 | rosacea | Derm Research, PLLC | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT05836753 Comparator | May → Nov 2023 | ischemic stroke | Beijing Tiantan Hospital | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-02-23 | Almirall, S.A. | Regulatory Almirall meets guidance for 2025, delivering 12.4% net sales growth and further pipeline progress, continuing its sustained growth trajectory with strong dermatology performance and commercial execution in Europe almirall.com ↗
Furthermore, Efinaconazole was approved in Germany for the treatment of nail fungal infections, and Sarecycline was approved in China for the treatment of acne. |
| 2026-01-29 | Almirall, S.A. | Regulatory Almirall announces the approval of Seysara® in China for the treatment of moderate-to-severe acne almirall.com ↗
Barcelona, January 29 th , 2026 – Almirall, S.A. (ALM) a global pharmaceutical company dedicated to medical dermatology announced today that China’s National Medical Products Administration (NMPA) has approved Seysara® (sarecycline hydrochloride). |
| 2019-11-12 | Almirall, S.A. | Results Almirall LLC Announces The Publication Of Long-Term Safety Data For The Use Of Seysara® (Sarecycline) Tablets In Patients 9 Years Of Age And Older almirall.com ↗
This extension study in patients 9 years and older showed safety and tolerability results that were consistent with the 12 week pivotal Phase 3 studies, including low rates of vestibular, phototoxic and gastrointestinal adverse events. |
| 2018-10-02 | Almirall, S.A. | Regulatory FDA approves Seysara™, a New Chemical Entity for moderate to severe acne almirall.com ↗
Almirall, S.A . announced today that the Food and Drug Administration (FDA) has approved Seysara TM (sarecycline), a new, innovative first in class tetracycline-derived oral antibiotic for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. |
All press releases naming this drug 10 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sarecycline | “Study to Evaluate the Efficacy, Safety, and Tolerability of Sarecycline for Treating Periorificial Dermatitis” NCT06461299 ↗ |
| Known as | P-00562 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2364632 ↗ |
| Known as | P-005672 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2364632 ↗ |
| Known as | PO-05672 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2364632 ↗ |
| Known as | Sareciclina | ChEMBL registry synonym — accepted as the source's own label CHEMBL2364632 ↗ |
| Known as | SARECYCLINE HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2364632 ↗ |
| Known as | Seysara | ChEMBL registry synonym — accepted as the source's own label CHEMBL2364632 ↗ |
| Known as | WC-3035 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2364632 ↗ |
| Modality | Small molecule | — CHEMBL2364632 ↗ |
| Route | Oral | “taken orally” NCT02320149 ↗ |