Drug Type Small molecule drug |
Synonyms Apremilast (JAN/USAN), pms-APREMILAST, 阿普斯特 + [7] |
Target |
Action inhibitors |
Mechanism PDE4 inhibitors(Phosphodieterase 4 inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (21 Mar 2014), |
RegulationOrphan Drug (United States), Overseas New Drugs Urgently Needed in Clinical Settings (China), Priority Review (China) |
Molecular FormulaC22H24N2O7S |
InChIKeyIMOZEMNVLZVGJZ-QGZVFWFLSA-N |
CAS Registry608141-41-9 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D08860 | Apremilast |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Pustulosis of Palms and Soles | Japan | 27 Mar 2025 | |
| Behcet Syndrome | United States | 19 Jul 2019 | |
| Oral Ulcer | Australia | 19 Mar 2015 | |
| Plaque psoriasis | European Union | 15 Jan 2015 | |
| Plaque psoriasis | Iceland | 15 Jan 2015 | |
| Plaque psoriasis | Liechtenstein | 15 Jan 2015 | |
| Plaque psoriasis | Norway | 15 Jan 2015 | |
| Psoriasis | United States | 23 Sep 2014 | |
| Arthritis, Psoriatic | United States | 21 Mar 2014 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Autoimmune Diseases | NDA/BLA | China | 30 Jan 2022 | |
| Pustular psoriasis | Phase 3 | Japan | 08 Mar 2022 | |
| Genital Diseases | Phase 3 | United States | 30 Jan 2022 | |
| Juvenile Idiopathic Arthritis | Phase 3 | United States | 30 Jan 2022 | |
| COVID-19 | Phase 3 | United States | 24 Nov 2020 | |
| COVID-19 | Phase 3 | Argentina | 24 Nov 2020 | |
| COVID-19 | Phase 3 | Brazil | 24 Nov 2020 | |
| COVID-19 | Phase 3 | Chile | 24 Nov 2020 | |
| COVID-19 | Phase 3 | Mexico | 24 Nov 2020 | |
| COVID-19 | Phase 3 | Russia | 24 Nov 2020 |
Phase 2 | 14 | uwffgjkrlf(vvfiuxvjei) = sjipukvsqx veqstkyenf (ffouvibuqb ) | Positive | 01 Nov 2025 | |||
Phase 3 | 308 | yjdvrpqvlk(brfdkfdvgf): OR = 0.42 (95.0% CI, 0.22 - 0.77) | Positive | 24 Oct 2025 | |||
Placebo (PBO) | |||||||
Phase 3 | 308 | qayzirsnyo(qhypjgdnus) = ubawpdeptz jwzivkpipt (yrpfhcests ) View more | Positive | 24 Oct 2025 | |||
Placebo | qayzirsnyo(qhypjgdnus) = rkzbkbniyg jwzivkpipt (yrpfhcests ) View more | ||||||
Phase 4 | - | 32 | (Baseline dactylitis) | pddcjmjuen(chdzefzxbb) = Statistically significant decreases in DEMRIQ-Vol (W24 and W48) and DEMRIQ-ME (W48) were observed for the MRI-determined most-affected joint (P< 0.05); DEMRIQ-IRE showed no significant change. azhutwtpdi (kqlxyylctw ) View more | Positive | 24 Oct 2025 | |
Phase 4 | 308 | jzomvbozmd(lnkyfycgoy) = unxujkzyhn pisacsetdr (aguysxvfyj ) View more | Positive | 24 Oct 2025 | |||
Placebo | jzomvbozmd(lnkyfycgoy) = ewixobjhbb pisacsetdr (aguysxvfyj ) View more | ||||||
Phase 3 | 245 | Placebo | agivckpsvc(osnrkoxoho) = lhjfgtgzde zfvbeiubjv (sesxzkgkoq ) View more | Positive | 29 Aug 2025 | ||
agivckpsvc(osnrkoxoho) = uttclphikv zfvbeiubjv (sesxzkgkoq ) View more | |||||||
Phase 3 | - | Placebo±DMARDs (PsA-1) | thdcqdexhd(zrpofrsukh) = xtawktucwi exbzrgduds (sejveazolu ) Met View more | Positive | 29 Aug 2025 | ||
OTEZLA 30 mg twice daily±DMARDs (PsA-1) | thdcqdexhd(zrpofrsukh) = vfwqzusbej exbzrgduds (sejveazolu ) Met View more | ||||||
Phase 3 | 207 | Placebo | cjhwrclhsv(zvprijseck) = qbfvdgszvf fifndnkmvk (srnzdpfuhz ) View more | Positive | 29 Aug 2025 | ||
OTEZLA 30 mg twice daily | cjhwrclhsv(zvprijseck) = upvckhpkfa fifndnkmvk (srnzdpfuhz ) View more | ||||||
Phase 3 | 245 | luvowoskvw(cqaedpruym) = mcysrjwvjq wgvvxikjfw (czhjzpkbtg ) View more | Positive | 30 Jul 2025 | |||
Placebo | luvowoskvw(cqaedpruym) = vzhthzsmkz wgvvxikjfw (czhjzpkbtg ) View more | ||||||
Phase 3 | 308 | gnchdsqsxc(lrsgzpurns): OR = 0.51 (95.0% CI, 0.27 - 0.97) View more | Positive | 11 Jun 2025 | |||
Placebo (PBO) |





