Drugs / Crisaborole
Crisaborole
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | EUCRISA | — | 2020-03-23 – 2023-04-03 | fda.gov ↗ |
| Approved | EU (EMA) | Staquis | — | 2020-03-27 | europa.eu ↗ |
| Approved | US (FDA) | EUCRISA | — | 2016-12-14 | fda.gov ↗ |
Trials 32
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04800185 | Mar 2021 → Apr 2022 | atopic eczema | University of California, Irvine | Completed | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT03760042 | Nov 2018 → Apr 2019 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03250663 | Oct 2017 → Jul 2022 | atopic eczema | Wake Forest University Health Sciences | Completed | No outcome recorded |
| Phase 1 | NCT03260595 | Sep → Nov 2017 | atopic eczema | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00763204 | Feb → Mar 2008 | psoriasis | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00762658 | Nov → Dec 2007 | psoriasis | Pfizer | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01652885 | Jul → Oct 2012 | atopic eczema | Pfizer | Completed | No outcome recorded |
| Phase 210 trials · 3 met primary · 1 missed | ||||||
| Phase 2 | NCT06118047 | Aug 2023 → Dec 2024 | colorectal cancer, toxic dermatosis | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 2 | NCT05298033 | Sep 2022 → Apr 2024 | vitiligo | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 2 | NCT04194814 | Nov 2020 → Sep 2021 | atopic eczema | Sheffield Teaching Hospitals NHS Foundation Trust | Completed | No outcome recorded |
| Phase 2 | NCT04091087 | Jun 2020 → Oct 2021 | leg dermatosis | Pfizer | Completed | Met primary |
| Phase 2 | NCT03954158 | Jun → Dec 2019 | atopic eczema | Pfizer | Completed | Met primary |
| Phase 2 | NCT03351114 | Sep 2018 → Mar 2020 | localized scleroderma | Duke University | Completed | No outcome recorded |
| Phase 2 | NCT03233529 | Jul 2017 → May 2018 | atopic eczema | Pfizer | Completed | Mixed |
| Phase 2 | NCT01602341 | Aug 2012 → Jan 2013 | atopic eczema | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT01301508 | May → Nov 2011 | atopic eczema | Pfizer | Completed | Met primary |
| Phase 2 | NCT01300052 | Jan → Jun 2011 | psoriasis | Pfizer | Completed | Missed primary |
| Phase 36 trials · 4 met primary · 1 missed | ||||||
| Phase 3 | NCT04498403 | Sep → Dec 2020 | atopic eczema | Pfizer | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT04360187 | Jul 2020 → Sep 2021 | atopic eczema | Pfizer | Completed | Met primary |
| Phase 3 | NCT04040192 | Sep 2019 → Jan 2022 | atopic eczema | Pfizer | Completed | Met primary |
| Phase 3 | NCT03645057 | Feb 2019 → Aug 2021 | atopic eczema | University of Rochester | Completed | Missed primary |
| Phase 3 | NCT02118792 | Mar 2014 → Apr 2015 | atopic eczema | Pfizer | Completed | Met primary |
| Phase 3 | NCT02118766 | Mar 2014 → Apr 2015 | atopic eczema | Pfizer | Completed | Met primary |
| Phase 49 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 | NCT07437534 | Mar → Apr 2026 overdue | atopic eczema | Hayat Abad Medical Complex, Peshawar | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07438509 | Mar → Sep 2026 overdue | atopic eczema | Jinnah Postgraduate Medical Centre | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05200403 | Jul 2022 → Feb 2024 | atopic eczema | Boston University | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT04214197 | Feb 2020 → Jul 2021 | atopic eczema | Massachusetts General Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04023084 | Oct 2019 → Feb 2022 | atopic eczema | Ann & Robert H Lurie Children's Hospital of Chicago | Completed | No outcome recorded |
| Phase 4 | NCT03567980 | Sep 2018 → Apr 2020 | seborrheic dermatitis | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 4 | NCT03539601 | Apr 2018 → Dec 2020 | atopic eczema | Pfizer | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT03356977 | Jan 2018 → Apr 2019 | atopic eczema | Pfizer | Completed | No outcome recorded |
| Comparator or background therapy12 trials | ||||||
| Phase 1 | NCT01258088 Comparator | Nov → Dec 2010 | psoriasis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT04299503 Comparator | Mar 2020 → Mar 2022 | alopecia areata | Tufts Medical Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT01029405 Comparator | Nov 2009 → May 2010 | psoriasis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00755196 Comparator | Sep → Dec 2008 | psoriasis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00759161 Comparator | Nov 2007 → Mar 2008 | psoriasis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT07162896 Comparator | Jun 2026 → Jan 2027 expected | atopic eczema | Shalamar Institute of Health Sciences | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05016284 Comparator | Nov → Dec 2022 | atopic eczema | Applied Biology, Inc. | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT07367932 Comparator | Feb → Apr 2026 overdue | atopic eczema | Cairo University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT03832010 Comparator | Dec 2019 → Feb 2024 | atopic eczema | Johns Hopkins University | Completed | No outcome recorded |
| Phase 4 | NCT03868098 Comparator | May 2019 → Nov 2020 | atopic eczema | Innovaderm Research Inc. | Completed | No outcome recorded |
| — | NCT07519174 Comparator | Jun → Nov 2026 expected | atopic eczema | Foundation University Islamabad | Not yet recruiting | No outcome recorded |
| — | NCT07537751 Comparator | Feb → Dec 2024 | atopic eczema | Noura Abdelmoneim Mohammed Elseessy | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2020-03-24 | Pfizer | Regulatory U.S. FDA Approves Supplemental New Drug Application (sNDA) for Expanded Indication of EUCRISA® (Crisaborole) Ointment, 2%, in Children as Young as 3 Months of Age With Mild-to-Moderate Atopic Dermatitis pfizer.com ↗
This supplemental approval makes EUCRISA the first and only steroid-free, topical prescription medication for mild-to-moderate AD patients as young as 3 months of age. |
| 2019-07-01 | Pfizer | Results Pfizer Announces Positive Top-Line Results from Phase 4 Study of Crisaborole Ointment, 2%, in Children Aged 3 Months to Less Than 24 Months with Mild to Moderate Atopic Dermatitis pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced top-line results from a Phase 4 study (CrisADe CARE 1) which showed that crisaborole ointment, 2%, was well-tolerated in children aged 3 months to less than 24 months with mild to moderate atopic dermatitis (AD), also known as eczema. |
| 2017-02-08 | Pfizer | Regulatory Pfizer Receives FDA Approval for EUCRISA™ (crisaborole) pfizer.com ↗
Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) approved EUCRISA TM (crisaborole) ointment 2%, a novel non-steroidal topical phosphodiesterase -4 (PDE-4) inhibitor for the treatment of mild to moderate atopic dermatitis (AD) in patients two years of age and older. |
| 2016-12-14 | Pfizer | Regulatory Pfizer Receives FDA Approval for EUCRISA™ (crisaborole), a Novel Non-Steroidal Topical Ointment for Mild to Moderate Atopic Dermatitis (Eczema) pfizer.com ↗
Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) approved EUCRISA TM (crisaborole) ointment 2%, a novel non-steroidal topical phosphodieterase-4 (PDE-4) inhibitor for the treatment of mild to moderate atopic dermatitis (AD) in patients two years of age and older. |
| 2016-12-14 | Pfizer | Regulatory Pfizer Announces FDA Approval of EUCRISA™ (crisaborole) pfizer.com ↗
Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) approved EUCRISA ™ (crisaborole) ointment, 2%. |
| 2016-07-13 | Pfizer | Results Pfizer Announces the Publication of Final Results from Two Pivotal Phase 3 Studies of Crisaborole Topical Ointment in Patients with Mild to Moderate Atopic Dermatitis pfizer.com ↗
The results seen in these pivotal Phase 3 studies demonstrate that crisaborole, if approved, could be a meaningful treatment option for patients with mild to moderate atopic dermatitis. |
All press releases naming this drug 6 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 45 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Crisaborole | “Crisaborole ointment, 2%, is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of patients with mild-to-moderate atopic dermatitis (AD).” PMID 38206678 ↗ Jan 202431“Crisaborole 2% ointment (right side) and Placebo vehicle ointment (left side)” NCT03760042 ↗ “Participants are given EUCRISA (crisaborole) ointment 2%.” NCT03250663 ↗ |
| Known as | An2728 | “A Phase I, Randomized, Observer-blind, Single-center, Vehicle- And Comparator-controlled, Initial Dose-ranging Study To Assess The Antipsoriatic Efficacy Of Different...” NCT00762658 ↗ |
| Known as | AN2728 Ointment, 5% | “AN2728 Ointment, 5%, twice daily for 12 weeks” NCT00755196 ↗ |
| Known as | Crisaborol | ChEMBL registry synonym — accepted as the source's own label CHEMBL484785 ↗ |
| Known as | EUCRISA | “specifically the Food and Drug Administration (FDA)-approved phosphodiesterase inhibitor, crisaborole ointment 2% (Eucrisa)” NCT04800185 ↗3“Drug: Crisaborole 2% Topical Application Ointment [EUCRISA” NCT07437534 ↗ “Participants are given EUCRISA (crisaborole) ointment 2%.” NCT03250663 ↗ |
| Known as | Staquis | ChEMBL registry synonym — accepted as the source's own label CHEMBL484785 ↗ |
| Action | Inhibit | “inhibition of phosphodiesterase 4 (PDE4)” PMID 26461821 ↗ Oct 2015 |
| Modality | Small molecule | “boron-based small-molecule PDE4 inhibitor” PMID 26461821 ↗ Oct 2015 |
| Route | Topical | “Patients will apply both test articles, AN2728 Ointment, 5%, and Ointment Vehicle twice daily for 12 weeks” NCT00755196 ↗ |