Drugs / LEO 32731
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT03812198 | Jan → Jun 2019 | — | LEO Pharma | Completed | No outcome recorded |
| Phase 1 | NCT03231124 | Jul → Aug 2017 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 1 | NCT03126578 | May → Oct 2017 | — | LEO Pharma | Completed | No outcome recorded |
| Phase 1 | NCT02753218 | Apr → May 2016 | psoriasis | LEO Pharma | Terminated | No outcome recorded |
| Phase 1 | NCT02496546 | Jul 2015 → Mar 2016 | atopic eczema | LEO Pharma | Completed | No outcome recorded |
| Phase 1 | NCT02126371 | May 2014 → Jan 2015 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 1 | NCT01310049 | Mar 2011 → Aug 2012 | — | LEO Pharma | Completed | No outcome recorded |
| Phase 24 trials · 1 met primary | ||||||
| Phase 2 | NCT05469464 | Jul 2022 → Jan 2024 | atopic eczema | UNION therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT05190419 | Dec 2021 → Nov 2022 | psoriasis | UNION therapeutics | Completed | Met primary |
| Phase 2 | NCT04982432 | Oct 2021 → Dec 2022 | hidradenitis suppurativa | Gregor Jemec | Unknown | No outcome recorded |
| Phase 2 | NCT02888236 | Sep 2016 → Jun 2017 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT02514694 Comparator | Jul → Dec 2015 | psoriasis | LEO Pharma | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2025-10-31 | UNION therapeutics | Results UNION therapeutics announces publication of biomarker modulation profile of orismilast using novel approach with tape-stripping and Olink technology uniontherapeutics.com ↗
In particular, key markers of the psoriasis disease pathology were significantly reduced in the two active arms (20mg/30mg) reaching an improvement of 51-%52% (IL-17A), 41-54% (CCL20) and 60-66% (TNFα) at Week 16. |
| 2025-02-21 | UNION therapeutics | Results UNION therapeutics announces presentation of preliminary data from Phase 2a investigator-initiated study with orismilast in ulcerative colitis at the 20th ECCO Congress uniontherapeutics.com ↗
The preliminary data from the proof-of-concept study suggests that orismilast exhibits therapeutic potential in moderate-to-severe ulcerative colitis, with three patients achieving complete remission. |
| 2025-01-10 | UNION therapeutics | Results UNION therapeutics to present at the Dermatology Summit 2025, opening the week of the 43rd Annual J.P. Morgan Health Care Conference uniontherapeutics.com ↗
The presentation will include recent data from Phase 2 studies of orismilast in atopic dermatitis as well as hidradenitis suppurativa, demonstrating good effect on lesions as well as early relief of core symptoms for patients. |
| 2024-09-25 | UNION therapeutics | Results UNION therapeutics announce results from the ADESOS Phase 2b study in atopic dermatitis confirming the potential of orismilast as a first-in-class safe and efficacious oral treatment uniontherapeutics.com ↗
Orismilast demonstrated clear treatment effect with statistical significance for all dose arms on the registrational endpoint of IGA0/1 at week 16 |
| 2024-03-15 | UNION therapeutics | Results UNION therapeutics announces publication of results from the OSIRIS Phase 2 study of orismilast in hidradenitis suppurativa in the Journal of the European Academy of Dermatology and Venereology uniontherapeutics.com ↗
67% of patients completing 16 weeks of treatment achieved HiSCR50, and the mean reduction in AN-count in patients completing treatment with orismilast was 33.1% |
| 2023-11-22 | UNION therapeutics | Results UNION therapeutics A/S announces publication of results from the IASOS Phase 2b study of orismilast in psoriasis in Journal of the American Academy of Dermatology uniontherapeutics.com ↗
In the Phase 2b study, orismilast significantly reduced Psoriasis Area and Severity Index (PASI) compared with placebo from baseline to week 16 |
| 2023-06-21 | UNION therapeutics | Results UNION therapeutics announces positive topline results from the OSIRIS investigator-initiated proof-of-concept study of oral orismilast in patients with hidradenitis suppurativa uniontherapeutics.com ↗
UNION therapeutics A/S (UNION), a privately-held, clinical stage, pharmaceutical development company focused on immunology and infectious disease, today announces positive topline results from the OSIRIS investigator-initiated proof-of-concept study with oral orismilast in adult patients with HS. |
| 2023-01-10 | UNION therapeutics | Regulatory UNION therapeutics receives FDA Fast Track designation for oral orismilast for the treatment of moderate to severe hidradenitis suppurativa uniontherapeutics.com ↗
UNION therapeutics A/S (UNION), a privately-held, multi-asset, clinical stage, pharmaceutical development company focused on immunology and infectious disease, today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to oral orismilast for the treatment of moderate to severe HS. |
| 2023-01-09 | UNION therapeutics | Results UNION therapeutics announces positive topline results from the IASOS Phase 2b study of oral orismilast in patients with moderate to severe psoriasis uniontherapeutics.com ↗
UNION therapeutics A/S (UNION), a privately-held, multi-asset, clinical stage, pharmaceutical development company focused on immunology and infectious disease, today announces positive topline results from the IASOS Phase 2b study of oral orismilast in adult patients with moderate to severe psoriasis. |
| 2022-12-22 | UNION therapeutics | Results UNION therapeutics announces two peer-reviewed publications of preclinical and clinical Phase 2a data on orismilast uniontherapeutics.com ↗
Described in the paper on the pharmacological properties of orismilast, the preclinical results demonstrated that orismilast is a potent and selective inhibitor of PDE4 subtypes involved in the inflammatory signaling cascades associated with chronic inflammatory diseases. |
| 2022-09-08 | UNION therapeutics | Results UNION therapeutics presents new data on orismilast at the 31st EADV Congress supporting orismilast’s potential as a first-in-class or best-in-class treatment for certain immunological diseases uniontherapeutics.com ↗
The preclinical results demonstrated that orismilast is a potent inhibitor of PDE4 subtypes involved in inflammatory signaling cascades associated with chronic inflammatory diseases. |
| 2022-09-01 | UNION therapeutics | Regulatory UNION therapeutics announces regulatory approval of Treatment Extension for the ongoing OSIRIS Phase 2a open label study with orismilast MR tablet for patients with Hidradenitis Suppurativa (HS) uniontherapeutics.com ↗
With the Treatment Extension, patients who have completed the OSIRIS study may continue treatment with orismilast MR tablets for a period of 52 weeks. |
| 2021-11-04 | UNION therapeutics | Regulatory UNION therapeutics receives FDA Fast Track designation for oral orismilast for the treatment of moderate to severe atopic dermatitis uniontherapeutics.com ↗
UNION therapeutics A/S, a privately-held, multi-asset, clinical stage, pharmaceutical company focused on immunology and infectious diseases, today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to oral orismilast for the treatment of moderate to severe AD. |
| 2021-01-07 | UNION therapeutics | Regulatory UNION therapeutics A/S receives FDA approval for IND of oral next generation PDE4-inhibitor (orismilast) for investigation in plaque psoriasis uniontherapeutics.com ↗
UNION therapeutics A/S (UNION) today announces that the US Food and Drug Administration (FDA) has approved an Investigational New Drug program (IND) for oral orismilast; a next generation PDE4-inhibitor for the treatment of plaque psoriasis in adults. |
All press releases naming this drug 28 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | LEO 32731 | “LEO 32731 ("Study Drug") is an investigational drug which is being developed by LEO Pharma A/S ("the Sponsor") for treatment of psoriasis.” NCT02514694 ↗10“LEO 32731 ("Study Drug") is an investigational drug” NCT02126371 ↗ |
| Known as | Orismilast | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05190419 ↗ |
| Action | Inhibit | “PD4 inhibitor” NCT04982432 ↗ |
| Route | Oral | “Part 1 and 2: Oral single dose of oral solution or capsule” NCT01310049 ↗ |
| Target | PDE4B | “Orismilast, a Potent and Selective PDE4B/D Inhibitor” PMID 40970551 ↗ Sep 2025 |