Last update 27 Mar 2025

Orismilast

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
IBI353, LEO-32731, LEO32731
+ [3]
Action
inhibitors
Mechanism
PDE4B inhibitors(Phosphodiesterase 4B inhibitors), PDE4D inhibitors(phosphodiesterase 4D inhibitors)
Originator Organization
Drug Highest PhasePhase 2
First Approval Date-
RegulationFast Track (United States)
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Structure/Sequence

Molecular FormulaC19H15Cl2F2NO7S
InChIKeyZININGNRPUGNSL-UHFFFAOYSA-N
CAS Registry1353546-86-7

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Dermatitis, AtopicPhase 2
United States
11 Jul 2022
Dermatitis, AtopicPhase 2
Germany
11 Jul 2022
Dermatitis, AtopicPhase 2
Hungary
11 Jul 2022
Dermatitis, AtopicPhase 2
Poland
11 Jul 2022
Autoimmune DiseasesPhase 2
China
30 Jan 2022
Autoimmune DiseasesPhase 2
Denmark
30 Jan 2022
Hidradenitis SuppurativaPhase 2-01 Oct 2021
Psoriasis vulgarisPhase 2
Germany
01 Sep 2016
Plaque psoriasisPhase 2
Germany
05 Jun 2016
Colitis, UlcerativePhase 2--
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
235
(Orismilast Modified Release Tablets 20 mg BID)
msxvzivhcv(pnhjpkpbtr) = rilgsgvkpp omaboqxnry (qrpyszjzvy, 4.89)
-
25 Mar 2025
(Orismilast Modified Release Tablets 30 mg BID)
msxvzivhcv(pnhjpkpbtr) = zfkimvdgtq omaboqxnry (qrpyszjzvy, 5.39)
Phase 2
10
hocdtdrnqn(ibcsueeqfh) = nesjyopscc ucrixpthdc (vtwzgyitjd )
Positive
21 Feb 2025
Phase 2
233
psxuohbenq(onjxzkercy) = qrfyqceohf cobusekobd (mwtcxhrgvw )
Positive
25 Sep 2024
psxuohbenq(onjxzkercy) = arntgpzvzd cobusekobd (mwtcxhrgvw )
Phase 2
202
Placebo
(Placebo Tablets BID)
gfasbjreay(dzgroylfor) = idoxanfcae wjugcmhlxj (kltaeaqwkw, 7.07)
-
16 Apr 2024
(Orismilast Modified Release Tablets 20 mg BID)
gfasbjreay(dzgroylfor) = ulqpavqyiw wjugcmhlxj (kltaeaqwkw, 6.80)
Phase 2
202
lntmbamhar(zoqlkroezn) = adxbnahony zgwatmznlu (jzxwlzioip )
Positive
11 Oct 2023
lntmbamhar(zoqlkroezn) = kiebkilthi zgwatmznlu (jzxwlzioip )
Phase 2
20
qkqffnopat(toosbhkgzs) = ihfhgoeidx ozplliqcub (iqbueoaers )
-
11 Oct 2023
qkqffnopat(toosbhkgzs) = eydohpwnpo ozplliqcub (iqbueoaers )
Phase 2
36
tsraxxejgc(ddgxmnhnfr) = The high GI AE (88.9%) and discontinuation rates in the phase 2a trial led to the development of an MR tablet to improve the GI tolerability by changing the release profile of orismilast. In the phase 1 trial, part 1 showed that orismilast MR achieved comparable PK, including t max , to orismilast IR, despite a slower dissolution rate. No nausea was observed in the MR arm and the rate of GI AEs was lower in the MR arm vs the IR arm (16.7% vs 33.3%, respectively). qovdmlltxi (mfwqsshgjd )
-
07 Sep 2022
Placebo
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Regulation

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