Drugs / Apremilast
Apremilast
also known as
CC-10004 · Otezla · Apremilast accord · CC-10004 (apremilast) · EU-sourced Otezla · Japan-sourced Otezla · US-sourced Otezla
Small molecule targets TNF via inhibition
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed scalp dermatosis 1 milestone | |||||
| Filed | US (FDA) | Otezla | scalp dermatosis | — | “A supplemental New Drug Application (sNDA) to expand the Prescribing Information to include data from the Phase 3 scalp psoriasis study is under review” amgen.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (6) | US (FDA) | OTEZLA | — | 2019-07-19 – 2025-07-23 | fda.gov ↗ |
| Approved | EU (EMA) | Otezla | — | 2015-01-15 | europa.eu ↗ |
| Approved | US (FDA) | OTEZLA | — | 2014-03-21 | fda.gov ↗ |
Trials 113 · started per year
today
US approved 2014
EU approved 2015
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07337434 | Dec 2025 → Jun 2026 overdue | psoriasis | Syeda Sana Zaman | Recruiting | No outcome recorded |
| Phase 110 trials | ||||||
| Phase 1 | NCT06324435 | May 2024 → Aug 2026 overdue | alcohol-related disorders | Yale University | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05703685 | Jun 2023 → Oct 2028 expected | depressive disorder | National Institute of Mental Health (NIMH) | Recruiting | No outcome recorded |
| Phase 1 | NCT04811573 | Mar → Aug 2021 | — | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 1 | NCT02777554 | Aug → Nov 2016 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT02802735 | Jun → Aug 2016 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT02641353 | Jan → Feb 2016 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT02236988 | Jan → Sep 2014 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT01634178 | Feb → Mar 2012 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT01561963 | Feb → Apr 2012 | — | Amgen | Completed | Mixed |
| Phase 1 | NCT01634191 | Feb → Mar 2012 | — | Amgen | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT03576287 | Jul 2017 → Dec 2019 | prurigo nodularis | Tanja Todberg, MD | Unknown | No outcome recorded |
| Phase 1/2 | NCT00889421 | Nov 2009 → Jun 2011 | uveitis | Oregon Health and Science University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT00708916 | Jun 2008 → Aug 2010 | discoid lupus erythematosus | NYU Langone Health | Completed | No outcome recorded |
| Phase 238 trials · 5 met primary · 3 missed | ||||||
| Phase 2 | NCT07850843 | Sep → Oct 2026 expected | chronic inducible urticaria | Rashid Latif Medical College | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT06509984 | Aug 2024 → Oct 2025 overdue | epidermolysis bullosa simplex | Centre Hospitalier Universitaire de Nice | Recruiting | No outcome recorded |
| Phase 2 | NCT05875714 | Jan 2022 → Dec 2024 | erythema multiforme | Robert Micheletti | Completed | No outcome recorded |
| Phase 2 | NCT04306965 | Aug 2020 → Jun 2022 | atopic eczema | Tufts Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT04488081 | Jul 2020 → Jul 2028 expected | COVID-19 | QuantumLeap Healthcare Collaborative | Active not recruiting | Missed primary |
| Phase 2 | NCT03836885 | Nov 2019 → Apr 2020 | lichen planus, oral | Sunnybrook Health Sciences Centre | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04057937 | Oct 2019 → Jan 2021 | palmoplantar pustulosis | Amgen | Completed | Met primary |
| Phase 2 | NCT04161456 | Oct 2019 → Feb 2021 | acne | Dr. Frank Behrens | Completed | No outcome recorded |
| Phase 2 | NCT04572997 | Nov 2018 → Aug 2019 | palmoplantar pustulosis | Kristian Reich | Completed | No outcome recorded |
| Phase 2 | NCT03529955 | Jun 2018 → Feb 2021 | adult dermatomyositis | Tulane University | Completed | No outcome recorded |
| Phase 2 | NCT03442088 | Jun 2018 → Sep 2021 | psoriasis | University Hospitals Cleveland Medical Center | Completed | Met primary |
| Phase 2 | NCT03239106 | Dec 2017 → Oct 2018 | — | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 2 | NCT03160248 | Jul 2017 → Sep 2021 | dermatitis | Technical University of Munich | Completed | No outcome recorded |
| Phase 2 | NCT03123016 | Apr 2017 → Aug 2019 | vitiligo | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 2 | NCT03036995 | Mar 2017 → Nov 2018 | vitiligo | Centre Hospitalier Universitaire de Nice | Completed | Missed primary |
| Phase 2 | NCT03049267 | Feb → Dec 2017 | hidradenitis suppurativa | M.B.A. van Doorn | Completed | No outcome recorded |
| Phase 2 | NCT02695212 | Jul 2016 → Aug 2017 | hidradenitis suppurativa | Florida Academic Dermatology Centers | Completed | No outcome recorded |
| Phase 2 | NCT02576678 | Oct 2015 → Sep 2017 | psoriasis | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT02289417 | Jan 2015 → Sep 2017 | ulcerative colitis | Amgen | Completed | Mixed |
| Phase 2 | NCT02087943 | Jun 2014 → Oct 2015 | atopic eczema | Amgen | Completed | Mixed |
| Phase 2 | NCT01988103 | Jul 2013 → Nov 2014 | psoriasis, psoriatic arthritis | Amgen | Completed | Met primary |
| Phase 2 | NCT01285310 | Dec 2010 → Feb 2012 | rheumatoid arthritis | Amgen | Terminated | Missed primary |
| Phase 2 | NCT01200264 | Sep 2010 → Dec 2011 | psoriasis | Duke University | Withdrawn | No outcome recorded |
| Phase 2 | NCT01200472 | Aug 2010 → Aug 2013 | arthropathy, erosive | University of Erlangen-Nürnberg Medical School | Completed | No outcome recorded |
| Phase 2 | NCT01045551 | Jun 2010 → Jan 2013 | rosacea | Julian M. Mackay-Wiggan | Completed | No outcome recorded |
| Phase 2 | NCT00997581 | Apr → Dec 2010 | gout | Dartmouth-Hitchcock Medical Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT01041625 | Feb 2010 → Feb 2012 | lichen planus | Virginia Clinical Research, Inc. | Unknown | No outcome recorded |
| Phase 2 | NCT01074502 | Feb → Jul 2010 | acne | University of North Carolina, Chapel Hill | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT00931242 | Jun 2009 → Mar 2010 | allergic contact dermatitis | Tufts Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT01393158 | May 2009 → Jul 2011 | atopic eczema | Oregon Health and Science University | Completed | No outcome recorded |
| Phase 2 | NCT00814632 | Dec 2008 → Feb 2011 | vulvodynia | Kenneth Peters, MD | Completed | No outcome recorded |
| Phase 2 | NCT00773734 | Sep 2008 → Aug 2009 | psoriasis | Amgen | Completed | Met primary |
| Phase 2 | NCT00869089 | Sep 2008 → Jan 2011 | prurigo nodularis | University Hospitals Cleveland Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT00701311 | Jun 2008 → Jan 2011 | chronic prostatitis | Kenneth Peters, MD | Completed | No outcome recorded |
| Phase 2 | NCT00521339 | Aug 2007 → Apr 2009 | psoriasis | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00456092 | Mar 2007 → May 2009 | psoriatic arthritis | Amgen | Completed | Met primary |
| Phase 2 | NCT00606450 | Apr 2006 → Feb 2007 | psoriasis | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00604682 | Jan → Oct 2005 | psoriasis | Amgen | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06863493 | Jun 2025 → Jun 2026 overdue | psoriasis | SFA Therapeutics | Not yet recruiting | No outcome recorded |
| Phase 328 trials · 14 met primary · 2 missed | ||||||
| Phase 3 | NCT06122649 | Nov 2023 → Feb 2025 | psoriasis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT06088199 | Oct 2023 → Aug 2026 overdue | psoriasis | Amgen | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05767047 | Mar 2023 → Mar 2036 expected | Behcet disease, psoriasis-related juvenile idiopathic arthritis | Amgen | Recruiting | No outcome recorded |
| Phase 3 | NCT05565560 | Jan 2023 → Nov 2025 | psoriasis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT04227314 | Apr 2022 → Dec 2026 expected | aphthous stomatitis | University Hospital, Rouen | Recruiting | No outcome recorded |
| Phase 3 | NCT04804553 | Mar 2022 → Mar 2028 expected | psoriasis-related juvenile idiopathic arthritis | Amgen | Recruiting | No outcome recorded |
| Phase 3 | NCT05174065 | Mar 2022 → Aug 2023 | palmoplantar pustulosis | Amgen | Completed | Met primary |
| Phase 3 | NCT04528082 | Sep 2021 → Feb 2030 expected | Behcet disease | Amgen | Recruiting | No outcome recorded |
| Phase 3 | NCT04908189 | Jul 2021 → Nov 2024 overdue | psoriatic arthritis | Bristol-Myers Squibb | Active not recruiting | Met primary |
| Phase 3 | NCT04590586 | Nov 2020 → Aug 2021 | COVID-19 | Amgen | Completed | Missed primary |
| Phase 3 | NCT04610476 | Oct 2020 → Oct 2024 | psoriatic arthritis, substance withdrawal syndrome | University of Erlangen-Nürnberg Medical School | Unknown | No outcome recorded |
| Phase 3 | NCT04175613 | Dec 2019 → Oct 2025 | psoriasis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT03930186 | Jun 2019 → May 2020 | psoriasis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT03721172 | Mar 2019 → Mar 2020 | psoriasis | Amgen | Completed | Met primary |
| Phase 3 | NCT03777436 | Feb 2019 → Sep 2021 | psoriasis | Amgen | Completed | Met primary |
| Phase 3 | NCT03701763 | Dec 2018 → Apr 2022 | psoriasis | Amgen | Completed | Met primary |
| Phase 3 | NCT03191539 | Nov 2017 → Jun 2019 | psoriatic arthritis | Hospital Universitari Vall d'Hebron Research Institute | Unknown | No outcome recorded |
| Phase 3 | NCT03123471 | May 2017 → Aug 2018 | psoriasis | Amgen | Completed | Met primary |
| Phase 3 | NCT02735707 | Apr 2016 → Feb 2026 overdue | pneumonia | UMC Utrecht | Recruiting | Mixed |
| Phase 3 | NCT02307513 | Dec 2014 → Sep 2017 | Behcet disease | Amgen | Completed | Met primary |
| Phase 3 | NCT01925768 | Sep 2013 → Feb 2015 | psoriatic arthritis | Amgen | Completed | Met primary |
| Phase 3 | NCT01690299 | Oct 2012 → Jul 2014 | psoriasis, psoriatic arthritis | Amgen | Completed | Met primary |
| Phase 3 | NCT01583374 | May 2012 → Feb 2014 | ankylosing spondylitis | Amgen | Completed | Missed primary |
| Phase 3 | NCT01307423 | Dec 2010 → Feb 2013 | psoriatic arthritis | Amgen | Completed | Met primary |
| Phase 3 | NCT01232283 | Nov 2010 → Mar 2012 | psoriasis | Amgen | Completed | Met primary |
| Phase 3 | NCT01212770 | Sep 2010 → Aug 2012 | psoriatic arthritis | Amgen | Completed | Met primary |
| Phase 3 | NCT01212757 | Sep 2010 → Jul 2012 | psoriatic arthritis | Amgen | Completed | Met primary |
| Phase 3 | NCT01172938 | Jun 2010 → Apr 2012 | psoriatic arthritis | Amgen | Completed | Met primary |
| Phase 428 trials · 4 met primary | ||||||
| Phase 4 | NCT07352566 | Aug 2026 → Jun 2030 expected | atopic eczema, psoriasis | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07432386 | May → Oct 2026 expected | psoriasis | Zarmeen Khawar | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06593197 | Jan 2025 → Dec 2026 expected | vitiligo | Dow University of Health Sciences | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT07708480 | Dec 2024 → May 2025 | hidradenitis suppurativa | Hayat Abad Medical Complex, Peshawar | Completed | No outcome recorded |
| Phase 4 | NCT06260904 | Jan 2024 → Oct 2025 | lichen planus, oral | All India Institute of Medical Sciences, Bhubaneswar | Completed | No outcome recorded |
| Phase 4 | NCT05926882 | Aug 2022 → Jun 2023 | alopecia areata | Jinnah Postgraduate Medical Centre | Completed | No outcome recorded |
| Phase 4 | NCT06032858 | Mar 2022 → Jul 2023 | psoriasis | Ghurki Trust and Teaching Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04908475 | Jun 2021 → Apr 2023 | psoriasis | AbbVie | Completed | Met primary |
| Phase 4 | NCT04102449 | Jul 2020 → Feb 2022 | psoriatic arthritis | Medical University of Graz | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT04822909 | Sep 2019 → Mar 2020 | erythema nodosum | Post Graduate Institute of Medical Education and Research, Chandigarh | Completed | No outcome recorded |
| Phase 4 | NCT03774875 | Mar 2019 → Feb 2021 | psoriasis | Amgen | Completed | Met primary |
| Phase 4 | NCT03741933 | Feb → Aug 2019 | hand dermatosis | George Washington University | Withdrawn | No outcome recorded |
| Phase 4 | NCT03783026 | Feb 2019 → Oct 2021 | psoriatic arthritis | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT03747939 | Dec 2018 → Dec 2022 | psoriatic arthritis | Amgen | Completed | Met primary |
| Phase 4 | NCT04515732 | Dec 2018 → Apr 2021 | psoriasis, psoriatic arthritis | Professor Mikkel Østergaard | Unknown | No outcome recorded |
| Phase 4 | NCT03521687 | Nov 2018 → Feb 2021 | central centrifugal cicatricial alopecia | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 4 | NCT03690544 | Oct 2018 → Jul 2021 | aphthous stomatitis | Mayo Clinic | Completed | No outcome recorded |
| Phase 4 | NCT03587194 | Jul 2018 → Jul 2019 | psoriasis | Psoriasis Treatment Center of Central New Jersey | Completed | No outcome recorded |
| Phase 4 | NCT03422640 | Jul 2018 → Jan 2019 | frontal fibrosing alopecia | Bellevue Dermatology | Unknown | No outcome recorded |
| Phase 4 | NCT03553433 | Jun 2018 → Dec 2019 | psoriasis | University of Zurich | Unknown | No outcome recorded |
| Phase 4 | NCT03453190 | Feb 2018 → Mar 2020 | psoriasis | Washington Dermatology Center | Unknown | No outcome recorded |
| Phase 4 | NCT03146247 | Oct 2017 → Mar 2019 | psoriasis | Diamant Thaci | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03082729 | Apr 2017 → Aug 2021 | cardiovascular disorder, psoriasis | University of Pennsylvania | Completed | No outcome recorded |
| Phase 4 | NCT03022617 | Jan 2017 → Sep 2020 | psoriasis | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 4 | NCT03000309 | Dec 2016 → Apr 2018 | psoriasis | Derm Research, PLLC | Completed | No outcome recorded |
| Phase 4 | NCT02558361 | Apr → Oct 2016 | psoriatic arthritis | University of South Florida | Withdrawn | No outcome recorded |
| Phase 4 | NCT02400749 | May 2015 → Sep 2016 | psoriasis | Innovaderm Research Inc. | Completed | No outcome recorded |
| Phase 4 | NCT02425826 | Apr 2015 → Feb 2016 | parapsoriasis | Amgen | Completed | Met primary |
| Phase not applicable3 trials | ||||||
| — | NCT07398651 | Dec 2026 expected | psoriatic arthritis | Tanta University | Not yet recruiting | No outcome recorded |
| — | NCT07366268 | May 2026 → May 2027 expected | psoriasis | Assiut University | Not yet recruiting | No outcome recorded |
| — | NCT01140503 | Feb 2010 → Aug 2011 | dermatomyositis | Stanford University | Terminated | No outcome recorded Stop: Enrollment |
| Phase not stated1 trial | ||||||
| — | NCT03740516 | — | Behcet disease | Amgen | No longer available | No outcome recorded |
| Comparator or background therapy24 trials | ||||||
| Phase 0 | NCT05601492 Comparator | Jun → Nov 2025 | psoriasis | Wake Forest University Health Sciences | Withdrawn | No outcome recorded |
| Phase 1 | NCT02963779 Comparator | Dec 2016 → Oct 2017 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT07029529 Comparator | May 2026 → Aug 2030 expected | alcohol-related disorders | Yale University | Recruiting | No outcome recorded |
| Phase 2 | NCT07325266 Comparator | Apr 2026 → Jan 2027 expected | alcohol abuse | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Recruiting | No outcome recorded |
| Phase 2 | NCT03656666 Comparator | Sep 2019 → Nov 2022 | female reproductive system disorder, lichen planus | Oslo University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT03175549 Comparator | Nov 2017 → Apr 2020 | alcohol dependence | The Scripps Research Institute | Completed | No outcome recorded |
| Phase 2 | NCT01204138 Comparator | Sep 2010 → Aug 2011 | rheumatoid arthritis | Stanford University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01250548 Comparator | May 2010 → Jun 2014 | rheumatoid arthritis | Baylor Research Institute | Completed | No outcome recorded |
| Phase 2 | NCT00866359 Comparator | Aug 2009 → May 2012 | Behcet disease | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00944658 Comparator | Aug 2009 → Jan 2011 | ankylosing spondylitis | Imperial College London | Completed | No outcome recorded |
| Phase 3 | NCT07712731 Comparator | Apr 2025 → Apr 2026 | psoriasis | Newsoara Biopharma Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT06588738 Comparator | Aug 2024 → Sep 2025 | psoriasis | Alumis Inc | Completed | Met primary |
| Phase 3 | NCT06586112 Comparator | Jul 2024 → Sep 2025 | psoriasis | Alumis Inc | Completed | Met primary |
| Phase 3 | NCT06088043 Comparator | Nov 2023 → Jan 2025 | psoriasis | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT06108544 Comparator | Nov 2023 → Dec 2024 | psoriasis | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT03168256 Comparator | Sep 2018 → Jan 2022 | psoriasis | Can-Fite BioPharma | Completed | Met primary |
| Phase 3 | NCT03624127 Comparator | Aug 2018 → Sep 2020 | psoriasis | Bristol-Myers Squibb | Completed | Met primary |
| Phase 3 | NCT03611751 Comparator | Jul 2018 → Nov 2020 | psoriasis | Bristol-Myers Squibb | Completed | Met primary |
| Phase 3 | NCT01194219 Comparator | Sep 2010 → Feb 2012 | psoriasis | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT04555707 Background | Jun 2020 → Jun 2021 | psoriasis | Derm Research, PLLC | Unknown | No outcome recorded |
| Phase 4 | NCT03441789 Background | Sep 2017 → Oct 2018 | psoriasis | L.H. Kircik, M.D. | Completed | No outcome recorded |
| Phase 4 | NCT02412644 Comparator | May 2015 → Jul 2016 | psoriasis | Psoriasis Treatment Center of Central New Jersey | Completed | No outcome recorded |
| Phase 4 | NCT02144857 Comparator | May 2014 → Sep 2023 | psoriasis | University of Athens | Unknown | No outcome recorded |
| — | NCT02684123 Comparator | Feb 2016 → Sep 2017 | alopecia areata | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 26
| Date | Issuer | Release |
|---|---|---|
| 2026-09-30 | Takeda | Results Zasocitinib Delivered Superior Efficacy Versus Deucravacitinib in New Phase 3 Head-to-Head Results, Reinforcing Potential to Deliver Rapid and Durable Skin Clearance in a Convenient Once-Daily Pill takeda.com ↗
Week 4: More patients treated with zasocitinib achieved Dermatology Life Quality Index (DLQI) 0/1, indicating psoriasis had no effect on their quality of life, versus placebo (nominal p<0.01 and p<0.001 in LATITUDE PsO 3001 and 3002, respectively) and apremilast (nominal p<0.01 in LATITUDE PsO 3002). |
| 2026-07-16 | Takeda | Results Takeda’s Zasocitinib Demonstrates Consistent, High Rates of Skin Clearance Across the Body, Including Hard-to-Treat and High-Impact Sites, in Phase 3 Psoriasis Studies takeda.com ↗
Scalp: 77% and 74% of patients with scalp psoriasis treated with zasocitinib achieved scalp-specific PGA (ssPGA) 0/1 response versus placebo (7% and 13%; p<0.001) and apremilast (42% and 30%; p<0.001) at week 16. |
| 2024-03-13 | Amgen | Results アムジェン社、オテズラ®（アプレミラスト）の 新たな研究データを2024年AADにて発表 amgen.co.jp ↗
オテズラの継続投与により、最長1年間にわたり乾癬の重症度および皮膚病変が持続的に改善しました。 |
| 2024-03-11 | Amgen | Results アムジェン社、日本人掌蹠膿疱症患者に対する アプレミラストの第III相臨床試験のデータを発表 amgen.co.jp ↗
アムジェン社（ナスダック：AMGN）は3月9日、日本人掌蹠膿疱症（Palmoplantar Pustulosis：PPP）患者を対象にアプレミラストの有効性および安全性を評価した、第Ⅲ相臨床試験の結果を発表しました。 |
| 2024-03-09 | Amgen | Results AMGEN PRESENTS NEW RESEARCH ON OTEZLA® (APREMILAST) AT AAD 2024 amgen.com ↗
Amgen (NASDAQ:AMGN) today announced new, 52-week results from the Phase 3 SPROUT study examining the use of Otezla ® (apremilast) in children and adolescents aged 6 to 17 years with moderate to severe plaque psoriasis. |
| 2023-11-07 | Amgen | Results AMGEN PRESENTS NEW RESEARCH IN EARLY PSORIATIC ARTHRITIS AT ACR 2023 amgen.com ↗
Amgen (NASDAQ:AMGN) today announced results from the global Phase 4 FOREMOST study evaluating Otezla ® (apremilast) in patients with early oligoarticular psoriatic arthritis. |
| 2023-10-17 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Pharmaceuticals receives ANDA approval for Apremilast Tablets, 10 mg, 20 mg and 30 mg glenmarkpharma.com ↗
Glenmark Pharmaceuticals receives ANDA approval for Apremilast Tablets, 10 mg, 20 mg and 30 mg |
| 2023-07-26 | AbbVie | Results SKYRIZI® (risankizumab) Achieved Superiority Versus Apremilast for Co-Primary Endpoints Among Adult Patients with Moderate Plaque Psoriasis in Phase 4 Head-to-Head Study abbvie.com ↗
AbbVie (NYSE: ABBV) today announced the British Journal of Dermatology published results from the head-to-head Phase 4 IMMpulse study that evaluated the efficacy and safety of SKYRIZI ® (risankizumab) compared to Otezla ® (apremilast) among adult patients with moderate plaque psoriasis eligible for systemic therapy. |
| 2023-06-01 | Amgen | Results アムジェン社、乾癬性関節炎に対するオテズラ®（アプレミラスト）の新たな研究データを2023年EULARにて発表 amgen.co.jp ↗
オテズラを投与した患者では、48週時までに炎症の臨床所見およびMRI評価の両方に改善が認められました。 |
| 2023-05-30 | Amgen | Results AMGEN PRESENTS NEW RESEARCH ON OTEZLA® (APREMILAST) IN PSORIATIC ARTHRITIS AT EULAR 2023 amgen.com ↗
Using MRI, the MOSAIC study visually captured an improvement in inflammation and no significant change in structural progression, with the effects being greater in patients with moderate as opposed to high disease activity. |
| 2022-09-08 | Amgen | Results AMGEN ANNOUNCES POSITIVE NEW DATA AT EADV 2022 FOR OTEZLA® (APREMILAST) amgen.com ↗
SPROUT Data Show Otezla Resulted in Significant Improvements in Measures of Moderate to Severe Plaque Psoriasis at Week 16 Compared With Placebo in Children Ages 6-17 |
| 2022-08-30 | Amgen | Results AMGEN TO PRESENT NEW, POSITIVE CLINICAL AND REAL-WORLD DATA ACROSS INFLAMMATION PORTFOLIO AT EADV 2022 amgen.com ↗
Presentations will cover a range of clinical data for Otezla ® (apremilast), including positive, 16-week results from the Phase 3 SPROUT study in children ages 6-17 with moderate to severe plaque psoriasis. |
| 2022-07-11 | Can-Fite BioPharma | Results Can-Fite to Submit FDA & EMA Registration Plans for Piclidenoson in the Oral Treatment of Moderate to Severe Psoriasis canfite.com ↗
Further analysis of the Phase III COMFORT™ data point towards a better safety profile for Piclidenoson as compared to Otezla, which induced gastro-intestinal adverse events in 6% of patients compared with 1% in patients treated with placebo or Piclidenoson. |
| 2022-06-29 | Can-Fite BioPharma | Results Can-Fite Announces Positive Top-Line Results from Piclidenoson Phase III COMFORT™ Study in Moderate to Severe Psoriasis canfite.com ↗
Secondary endpoint parameters at week 32 comparing Piclidenoson to the active control drug, Otezla, revealed inferiority with respect to PASI 75 (17% vs. 26.2%, respectively) and PASI 50 (34.1% vs. 49.5%, respectively) |
| 2022-03-25 | Amgen | Results AMGEN ANNOUNCES NEW OTEZLA (APREMILAST) DATA AT AAD CONGRESS 2022 amgen.com ↗
Results from the PPP-001 trial showed that apremilast demonstrated meaningful and early imp |
| 2021-12-20 | Amgen | Regulatory FDA APPROVES OTEZLA® (APREMILAST) FOR THE TREATMENT OF ADULT PATIENTS WITH PLAQUE PSORIASIS, REGARDLESS OF SEVERITY LEVEL amgen.com ↗
Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Otezla ® (apremilast) for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy. |
| 2021-12-01 | Amgen | Results Amgen Announces Positive Top-Line Results From Otezla® (apremilast) Phase 3 DISCREET Study In Moderate To Severe Genital Psoriasis amgen.com ↗
Amgen (NASDAQ: AMGN) today announced positive top-line results from the DISCREET trial, a Phase 3, multicenter, randomized, placebo-controlled, double-blind study to assess the efficacy of Otezla ® (apremilast) in adults with moderate to severe genital psoriasis and moderate to severe plaque psoriasis. |
| 2021-09-24 | Zydus Lifesciences Limited | Regulatory Zydus Cadila receives final approval from USFDA for Apremilast Tablets zyduslife.com ↗ |
| 2021-05-05 | Amgen | Regulatory FDA Accepts Amgen's Supplemental New Drug Application For Otezla® (apremilast) For Adults With Mild-To-Moderate Plaque Psoriasis amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Otezla ® (apremilast) for the treatment of adults with mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy. |
| 2021-04-23 | Amgen | Results OTEZLA® (apremilast) Significantly Improved Measures Of Disease Severity In Adults With Mild-To-Moderate Plaque Psoriasis amgen.com ↗
Amgen (NASDAQ:AMGN) today announced Otezla ® (apremilast) improved measures of disease severity in adults with mild-to-moderate plaque psoriasis regardless of their Body Surface Area (BSA) affected by the disease, according to findings from the placebo-controlled, Phase 3 ADVANCE trial. |
| 2021-04-23 | Bristol-Myers Squibb | Results Bristol Myers Squibb Presents Positive Data from Two Pivotal Phase 3 Psoriasis Studies Demonstrating Superiority of Deucravacitinib Compared to Placebo and Otezla® (apremilast) bms.com ↗
Deucravacitinib demonstrated superior skin clearance compared with Otezla ® (apremilast) for key secondary endpoints in both studies, as measured by PASI 75 and sPGA 0/1 responses at Week 16 and Week 24. |
| 2021-02-22 | Amgen | Regulatory Amgen Submits Supplemental New Drug Application for Otezla® (apremilast) for Adults with Mild-To-Moderate Plaque Psoriasis amgen.com ↗
Amgen (NASDAQ:AMGN) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Otezla ® (apremilast) for the treatment of adults with mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy. |
| 2020-12-31 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Pharmaceuticals receives ANDA final approval for Tadalafil Tablets, 2.5 mg, 5 mg, 10 mg and 20 mg; and receives ANDA tentative approvals for Gabapentin Enacarbil Extended-Release Tablets, 300 mg and 600 mg and Apremilast Tablets, 10 mg, 20 mg and 30 mg glenmarkpharma.com ↗
Additionally, Glenmark has received tentative approval for Apremilast Tablets, 10 mg, 20 mg and 30 mg, the generic version of Otezla® Tablets, 10 mg, 20 mg and 30 mg, of Amgen, Inc. |
| 2020-11-03 | Bristol-Myers Squibb | Results Bristol Myers Squibb Announces Deucravacitinib (BMS-986165) Demonstrated Superiority to Placebo and Otezla® (apremilast) in Pivotal Phase 3 Psoriasis Study bms.com ↗
The trial also met multiple key secondary endpoints, including showing deucravacitinib was superior to Otezla ® (apremilast) in the proportion of patients reaching a PASI 75 response and sPGA 0/1 at Week 16. |
| 2020-05-06 | Amgen | Results Amgen Announces Positive Top-Line Results From Otezla® (apremilast) Phase 3 ADVANCE Study In Mild-To-Moderate Plaque Psoriasis amgen.com ↗
Amgen (NASDAQ:AMGN) today announced positive top-line results from the ADVANCE trial, a Phase 3, multicenter, randomized, placebo-controlled, double-blind study to assess the efficacy of Otezla ® (apremilast) in adults with mild-to-moderate plaque psoriasis. |
| 2019-11-16 | Zydus Lifesciences Limited | Regulatory Zydus receives tentative approval from the USFDA for Apremilast Tablets zyduslife.com ↗
Zydus Cadila has received the tentative approval from the USFDA to market Apremilast Tablets (US RLD- Otezla®) 10 mg, 20 mg, and 30 mg. |
All press releases naming this drug 35 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 140 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Apremilast | “Bioequivalence of Three Different Tablet Formulations of 30 mg of Apremilast (EU-sourced Otezla® vs. US-sourced Otezla® vs. Japan-sourced Otezla®) Administered in Healthy Male...” NCT04811573 ↗126“Study of the Safety and Effectiveness of Oral SFA-002 Compared to Oral Apremilast (Otezla) Tablets and Placebo in Mild to Severe Plaque Psoriasis” NCT06863493 ↗ |
| Known as | Apremilast accord | ChEMBL registry synonym — accepted as the source's own label CHEMBL514800 ↗ |
| Known as | CC-10004 | “This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with mild...” NCT03721172 ↗14“Apremilast (CC-10004) is a novel oral agent that modulates multiple inflammatory pathways through targeted phosphodiesterase type 4 (PDE4) enzyme inhibition.” NCT01212757 ↗ “Efficacy Study of Apremilast (CC-10004) in Subjects With Erosive Hand Osteoarthritis” NCT01200472 ↗ “Apremilast (CC-10004)in the Treatment of Ankylosing Spondylitis (AS)” NCT00944658 ↗ “Apremilast (CC-10004)” NCT03701763 ↗ “Apremilast (CC-10004)” NCT03747939 ↗ “Apremilast (CC-10004)” NCT01041625 ↗ “Apremilast (CC-10004)” NCT00866359 ↗ |
| Known as | CC-10004 (apremilast) | “CC-10004 (apremilast)” NCT00931242 ↗ |
| Known as | EU-sourced Otezla | “Bioequivalence of Three Different Tablet Formulations of 30 mg of Apremilast (EU-sourced Otezla® vs. US-sourced Otezla® vs. Japan-sourced Otezla®) Administered in Healthy Male...” NCT04811573 ↗ |
| Known as | Japan-sourced Otezla | “Bioequivalence of Three Different Tablet Formulations of 30 mg of Apremilast (EU-sourced Otezla® vs. US-sourced Otezla® vs. Japan-sourced Otezla®) Administered in Healthy Male...” NCT04811573 ↗ |
| Known as | Otezla | “Primary Objective: To evaluate the effectiveness of Otezla (apremilast®) in promoting maintenance of response in those subjects who obtained PASI-75 at week 12 of phototherapy.” NCT02412644 ↗6“Apremilast (brand name Otezla) is a medication for the treatment of certain types of psoriasis and psoriatic arthritis.” NCT03082729 ↗ “Apremilast (Otezla), oral medication Day 1: 10 mg in the morning.” NCT05875714 ↗ |
| Known as | US-sourced Otezla | “Bioequivalence of Three Different Tablet Formulations of 30 mg of Apremilast (EU-sourced Otezla® vs. US-sourced Otezla® vs. Japan-sourced Otezla®) Administered in Healthy Male...” NCT04811573 ↗ |
| Action | Inhibit | “Apremilast, a specific inhibitor of phosphodiesterase 4” PMID 23588944 ↗ Apr 2013 |
| Modality | Small molecule | “Apremilast, a small molecule specific inhibitor of phosphodiesterase 4” PMID 23986162 ↗ Aug 2013 |
| Route | Oral | “Capsules for oral administration” NCT00456092 ↗ |
| Target | TNF | “shown to inhibit TNF production in a mouse model of inflammation.” NCT00944658 ↗ |