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 · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 112 · 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 | NCT01634191 | Feb → Mar 2012 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT01561963 | Feb → Apr 2012 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT01634178 | 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 |
| Phase 1/2 | NCT00708916 | Jun 2008 → Aug 2010 | discoid lupus erythematosus | NYU Langone Health | Completed | No outcome recorded |
| Phase 237 trials | ||||||
| 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 | No outcome recorded |
| Phase 2 | NCT03836885 | Nov 2019 → Apr 2020 | lichen planus, oral | Sunnybrook Health Sciences Centre | Withdrawn | No outcome recorded |
| Phase 2 | NCT04057937 | Oct 2019 → Jan 2021 | palmoplantar pustulosis | Amgen | Completed | No outcome recorded |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 2 | NCT02087943 | Jun 2014 → Oct 2015 | atopic eczema | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT01988103 | Jul 2013 → Nov 2014 | psoriasis, psoriatic arthritis | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT01285310 | Dec 2010 → Feb 2012 | rheumatoid arthritis | Amgen | Terminated | No outcome recorded |
| 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 |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| 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 | ||||||
| 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 overdue | psoriasis | Amgen | Active not recruiting | 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 | No outcome recorded |
| Phase 3 | NCT04528082 | Sep 2021 → Feb 2030 expected | Behcet disease | Amgen | Recruiting | No outcome recorded |
| Phase 3 | NCT04908189 | Jul 2021 → Feb 2024 overdue | psoriatic arthritis | Bristol-Myers Squibb | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04590586 | Nov 2020 → Aug 2021 | COVID-19 | Amgen | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT03777436 | Feb 2019 → Sep 2021 | psoriasis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT03701763 | Dec 2018 → Apr 2022 | psoriasis | Amgen | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT02735707 | Apr 2016 → Feb 2026 overdue | pneumonia | UMC Utrecht | Recruiting | No outcome recorded |
| Phase 3 | NCT02307513 | Dec 2014 → Sep 2017 | Behcet disease | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01925768 | Sep 2013 → Feb 2015 | psoriatic arthritis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01690299 | Oct 2012 → Jul 2014 | psoriasis, psoriatic arthritis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01583374 | May 2012 → Feb 2014 | ankylosing spondylitis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01307423 | Dec 2010 → Feb 2013 | psoriatic arthritis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01232283 | Nov 2010 → Mar 2012 | psoriasis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01212770 | Sep 2010 → Aug 2012 | psoriatic arthritis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01212757 | Sep 2010 → Jul 2012 | psoriatic arthritis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01172938 | Jun 2010 → Apr 2012 | psoriatic arthritis | Amgen | Completed | No outcome recorded |
| Phase 428 trials | ||||||
| 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 | No outcome recorded |
| Phase 4 | NCT04102449 | Jul 2020 → Feb 2022 | psoriatic arthritis | Medical University of Graz | Withdrawn | No outcome recorded |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| 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 |
| 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 | No outcome recorded |
| 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 |
| Phase not stated1 trial | ||||||
| — | NCT03740516 | — | Behcet disease | Amgen | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 24 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05601492 Comparator | Jun → Nov 2025 | psoriasis | Wake Forest University Health Sciences | Withdrawn | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT02963779 Comparator | Dec 2016 → Oct 2017 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 28 trials | ||||||
| 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 |
| 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 39 trials | ||||||
| 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 | No outcome recorded |
| Phase 3 | NCT06586112 Comparator | Jul 2024 → Sep 2025 | psoriasis | Alumis Inc | Completed | No outcome recorded |
| Phase 3 | NCT06108544 Comparator | Nov 2023 → Dec 2024 | psoriasis | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT06088043 Comparator | Nov 2023 → Jan 2025 | psoriasis | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT03168256 Comparator | Sep 2018 → Jan 2022 | psoriasis | Can-Fite BioPharma | Completed | No outcome recorded |
| Phase 3 | NCT03624127 Comparator | Aug 2018 → Sep 2020 | psoriasis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT03611751 Comparator | Jul 2018 → Nov 2020 | psoriasis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT01194219 Comparator | Sep 2010 → Feb 2012 | psoriasis | Amgen | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| 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 |
| Phase not applicable1 trial | ||||||
| — | NCT02684123 Comparator | Feb 2016 → Sep 2017 | alopecia areata | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
Press releases naming this drug 16 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-08-20 | Amgen | OTEZLA® (APREMILAST) NOW AVAILABLE IN THE U.S. FOR MODERATE TO SEVERE PEDIATRIC PLAQUE PSORIASIS amgen.com ↗ |
| 2024-03-09 | Amgen | AMGEN PRESENTS NEW RESEARCH ON OTEZLA® (APREMILAST) AT AAD 2024 amgen.com ↗ |
| 2023-07-26 | AbbVie | 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 ↗ |
| 2023-05-30 | Amgen | AMGEN PRESENTS NEW RESEARCH ON OTEZLA® (APREMILAST) IN PSORIATIC ARTHRITIS AT EULAR 2023 amgen.com ↗ |
| 2023-04-19 | Amgen | AMGEN WINS PATENT APPEAL ON OTEZLA® (APREMILAST) amgen.com ↗ |
| 2022-09-08 | Amgen | AMGEN ANNOUNCES POSITIVE NEW DATA AT EADV 2022 FOR OTEZLA® (APREMILAST) amgen.com ↗ |
| 2022-03-25 | Amgen | AMGEN ANNOUNCES NEW OTEZLA (APREMILAST) DATA AT AAD CONGRESS 2022 amgen.com ↗ |
| 2021-12-20 | Amgen | FDA APPROVES OTEZLA® (APREMILAST) FOR THE TREATMENT OF ADULT PATIENTS WITH PLAQUE PSORIASIS, REGARDLESS OF SEVERITY LEVEL amgen.com ↗ |
| 2021-12-01 | Amgen | Amgen Announces Positive Top-Line Results From Otezla® (apremilast) Phase 3 DISCREET Study In Moderate To Severe Genital Psoriasis amgen.com ↗ |
| 2021-09-20 | Amgen | Amgen Wins Patent Case on Otezla® (apremilast) amgen.com ↗ |
| 2021-05-05 | Amgen | FDA Accepts Amgen's Supplemental New Drug Application For Otezla® (apremilast) For Adults With Mild-To-Moderate Plaque Psoriasis amgen.com ↗ |
| 2021-04-23 | Amgen | OTEZLA® (apremilast) Significantly Improved Measures Of Disease Severity In Adults With Mild-To-Moderate Plaque Psoriasis amgen.com ↗ |
| 2021-02-22 | Amgen | Amgen Submits Supplemental New Drug Application for Otezla® (apremilast) for Adults with Mild-To-Moderate Plaque Psoriasis amgen.com ↗ |
| 2020-05-06 | Amgen | Amgen Announces Positive Top-Line Results From Otezla® (apremilast) Phase 3 ADVANCE Study In Mild-To-Moderate Plaque Psoriasis amgen.com ↗ |
| 2019-11-21 | Amgen | Amgen Completes Acquisition Of Otezla® (apremilast) amgen.com ↗ |
| 2019-08-26 | Amgen | Amgen To Acquire Otezla® For $13.4 Billion In Cash, Or Approximately $11.2 Billion Net Of Anticipated Future Cash Tax Benefits amgen.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 139 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 ↗125“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)” NCT00866359 ↗ “Apremilast (CC-10004)” NCT03747939 ↗ “Apremilast (CC-10004)” NCT01041625 ↗ “Apremilast (CC-10004)” NCT03701763 ↗ |
| 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 ↗ |