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9 Diseases |  |
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2 Trials |  |
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- ||||||| Moizerto (difamilast) / Otsuka, Medimetriks
Trial completion: A Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - Aug 9, 2024
P3, N=542, Completed, Sponsor: Acrotech Biopharma Inc.
Active, not recruiting --> Completed
- || Opzelura (ruxolitinib cream) / Incyte
Clinical, Retrospective data, Review, Journal: Topical anti-inflammatory treatments for eczema: network meta-analysis. (Pubmed Central) - Aug 6, 2024
TCI and crisaborole 2% were ranked most likely to cause local application-site reactions and TCS least likely. We found no evidence for increased skin thinning with short-term TCS but an increase with longer-term TCS.
- | Moizerto (difamilast) / Otsuka, Medimetriks
Journal: Difamilast, a Topical Phosphodiesterase 4 Inhibitor, Produces Soluble ST2 via the AHR-NRF2 Axis in Human Keratinocytes. (Pubmed Central) - Jul 31, 2024
Additionally, the knockdown of AHR or NRF2 abolished the difamilast-induced sST2 production. These results indicate that difamilast treatment produces sST2 via the AHR-NRF2 axis, contributing to improving AD symptoms by inhibiting IL-33 activity.
- | Moizerto (difamilast) / Otsuka, Medimetriks
Journal: Topical application of a PDE4 inhibitor ameliorates atopic dermatitis through inhibition of basophil IL-4 production. (Pubmed Central) - Apr 23, 2024
Difamilast suppressed IL-4 production from basophils activated in vitro, at least in part, through inhibition of ERK phosphorylation. Taken together, difamilast appeared to ameliorate AD inflammation through the suppression of basophil IL-4 production in the skin lesion.
- ||||| Moizerto (difamilast) / Otsuka, Medimetriks
Enrollment closed, Trial completion date, Trial primary completion date: A Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - Apr 2, 2024
P3, N=500, Active, not recruiting, Sponsor: Acrotech Biopharma Inc.
Taken together, difamilast appeared to ameliorate AD inflammation through the suppression of basophil IL-4 production in the skin lesion. Recruiting --> Active, not recruiting | Trial completion date: Jun 2024 --> Oct 2024 | Trial primary completion date: Mar 2024 --> Jul 2024
- || Moizerto (difamilast) / Otsuka, Medimetriks
Trial completion: A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis (clinicaltrials.gov) - Feb 20, 2024
P3, N=41, Completed, Sponsor: Otsuka Pharmaceutical Co., Ltd.
Recruiting --> Active, not recruiting | Trial completion date: Jun 2024 --> Oct 2024 | Trial primary completion date: Mar 2024 --> Jul 2024 Active, not recruiting --> Completed
- || Review, Journal, Metastases: Treatment of atopic dermatitis: Recently approved drugs and advanced clinical development programs. (Pubmed Central) - Jan 8, 2024
in 2017), tralokinumab (anti-IL-13 in 2021), lebrikizumab (anti-IL-13 in 2023), and the oral janus kinase (JAK) inhibitors (JAKi) targeting JAK1/2 (baricitinib in 2020 in the EU) or JAK1 (upadacitinib in 2021 and abrocitinib in 2022)...Among the topical therapies, tapinarof (aryl hydrocarbon receptor), ruxolitinib (JAK1/2i), delgocitinib (pan-JAKi), asivatrep (anti-transient receptor potential vanilloid), and phosphodiesterase-4-inhibitors (roflumilast, difamilast) are discussed. Among systemic therapies, current data on cord-blood-derived mesenchymal stem cells, CM310 (anti IL-4R?), nemolizumab (anti-IL-31RA), anti-OX40/OX40L-antibodies, neurokinin-receptor-1-antagonists, and difelikefalin (?-opioid-R) are reported.
- || Opzelura (ruxolitinib cream) / Incyte, Maruho
Retrospective data, Review, Journal: Topical treatments for atopic dermatitis (eczema): systematic review and network meta-analysis of randomized trials. (Pubmed Central) - Dec 17, 2023
For individuals with AD, pimecrolimus, tacrolimus, and moderate-potency TCS are among the most effective in improving and maintaining multiple AD outcomes. Topical antibiotics may be among the least effective.
- || Moizerto (difamilast) / Otsuka, Medimetriks
Review, Journal: Difamilast for the treatment of atopic dermatitis. (Pubmed Central) - Jul 4, 2023
In 2021, difamilast was the first phosphodiesterase 4inhibitor to acquire manufacturing and marketing approval in Japan for the treatment of adult and pediatric patients (2 years of age and older) with AD. This article is a narrative review of the current literature on difamilast in the management of AD.
- | Moizerto (difamilast) / Otsuka, Medimetriks
Journal: Pharmacological Profile of Difamilast, a Novel Selective Phosphodiesterase 4 Inhibitor, for the Topical Treatment of Atopic Dermatitis. (Pubmed Central) - Jun 19, 2023
Significance Statement This is the first report on the nonclinical pharmacological profile of difamilast ointment, a novel topical PDE4 inhibitor that demonstrated utility in clinical trials in patients with atopic dermatitis. Difamilast, which has high PDE4 selectivity (especially for the PDE4B subtype), ameliorated chronic allergic contact dermatitis in mice after topical application, with a pharmacokinetic profile in animals that suggests few systemic side effects; thus, difamilast is a promising new therapeutic treatment for atopic dermatitis.
- | Moizerto (difamilast) / Otsuka, Medimetriks
Journal: PDE4 inhibition by difamilast regulates filaggrin and loricrin expression via keratinocyte proline-rich protein in human keratinocytes. (Pubmed Central) - Jun 5, 2023
Difamilast, which has high PDE4 selectivity (especially for the PDE4B subtype), ameliorated chronic allergic contact dermatitis in mice after topical application, with a pharmacokinetic profile in animals that suggests few systemic side effects; thus, difamilast is a promising new therapeutic treatment for atopic dermatitis. These findings may provide further guidance for therapeutic strategies in the treatment of AD using difamilast.
- | Review, Journal: New molecules for atopic dermatitis treatment beyond biological therapy. (Pubmed Central) - May 19, 2023
These findings may provide further guidance for therapeutic strategies in the treatment of AD using difamilast. These new drugs (systemic and topical) are needed to increase the success of AD treatment, particularly for patients who do not or no longer respond to treatment.
- difamilast (MM36) / Otsuka, Medimetriks
PDE4 inhibition by difamilast regulates filaggrin and loricrin expression via keratinocyte proline-rich protein in human keratinocytes (Room B (Eminence Hall) ) - Apr 13, 2023 - Abstract #ISID2023ISID_2081;
These new drugs (systemic and topical) are needed to increase the success of AD treatment, particularly for patients who do not or no longer respond to treatment. Sponsored by Otsuka Pharmaceutical
- |||||| difamilast (MM36) / Otsuka, Medimetriks
Enrollment open, Head-to-Head: To Demonstrate the Superiority of IMP (0.3% and 1% OPA-15406 Ointment) Versus the Vehicle in Pediatric Patients With AD (clinicaltrials.gov) - Feb 24, 2023
P3, N=240, Recruiting, Sponsor: Otsuka Beijing Research Institute
Sponsored by Otsuka Pharmaceutical Not yet recruiting --> Recruiting
- |||||| difamilast (MM36) / Otsuka, Medimetriks
Enrollment open, Head-to-Head: To Demonstrate the Superiority of IMP (1% OPA-15406 Ointment) to the Vehicle in Adult Patients With AD (clinicaltrials.gov) - Feb 15, 2023
P3, N=270, Recruiting, Sponsor: Otsuka Beijing Research Institute
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- || Moizerto (difamilast) / Otsuka, Medimetriks
Enrollment closed: A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis (clinicaltrials.gov) - Jan 5, 2023
P3, N=40, Active, not recruiting, Sponsor: Otsuka Pharmaceutical Co., Ltd.
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- |||||||||| difamilast (MM36) / Otsuka, Medimetriks
New P3 trial, Head-to-Head: To Demonstrate the Superiority of IMP (1% OPA-15406 Ointment) to the Vehicle in Adult Patients With AD (clinicaltrials.gov) - Dec 28, 2022
P3, N=270, Not yet recruiting, Sponsor: Otsuka Beijing Research Institute
- |||||||||| difamilast (MM36) / Otsuka, Medimetriks
New P3 trial, Head-to-Head: To Demonstrate the Superiority of IMP (0.3% and 1% OPA-15406 Ointment) Versus the Vehicle in Pediatric Patients With AD (clinicaltrials.gov) - Dec 14, 2022
P3, N=240, Not yet recruiting, Sponsor: Otsuka Beijing Research Institute
- |||||||||| difamilast (MM36) / Otsuka, Medimetriks
New P3 trial: This Study is to Assess the Efficacy of Difamilast Ointment in Mild to Moderate Atopic Dermatitis(AD) (clinicaltrials.gov) - Nov 8, 2022
P3, N=336, Recruiting, Sponsor: Acrotech Biopharma Inc.
- || difamilast (MM36) / Otsuka, Medimetriks
Retrospective data, Review, Journal: Clinical efficacy and safety of topical difamilast in the treatment of patients with atopic dermatitis: a systematic review and meta-analysis of randomized controlled trials. (Pubmed Central) - Oct 11, 2022
No difference in treatment-related adverse events was identified. This meta-analysis suggests that topical difamilast is an effective and safe treatment for mild-to-moderate AD.
- | Moizerto (difamilast) / Otsuka, Medimetriks
New P3 trial: A Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - Oct 7, 2022
P3, N=500, Recruiting, Sponsor: Acrotech Biopharma Inc.
- | Opzelura (ruxolitinib cream) / Incyte, Maruho
Journal: What's New in Topicals for Atopic Dermatitis? (Pubmed Central) - Sep 14, 2022
We also review novel targeted therapies that are in early phase clinical trials, including AMTX-100, BEN-2293, and PRN473. Preliminary findings on efficacy and tolerability of most of these agents are promising, but further studies are warranted to evaluate the long-term safety and efficacy of these novel agents against the current standard of care.
- || Opzelura (ruxolitinib cream) / Incyte, Maruho
Review, Journal: New and Upcoming Topical Treatments for Atopic Dermatitis: A Review of the Literature. (Pubmed Central) - Sep 13, 2022
Larger, long-term studies are still required to evaluate the efficacy and safety of these novel compounds in the long run and weigh their advantages over present treatments. In this review, we aim to provide an overview of the latest knowledge about AD topical treatments, echoing upcoming research trends.
- || Opzelura (ruxolitinib cream) / Incyte, Maruho
Review, Journal: New Topical Therapies in Development for Atopic Dermatitis. (Pubmed Central) - Jun 23, 2022
The available data seems promising, with some drugs already approved (ruxolitinib being the most recent), and several are in an advanced stage of development and will soon be available for treatment of mild to moderate disease, namely tapinarof, difamilast, and roflumilast. However, longer and larger prospective studies are needed to assess the long-term efficacy and safety of these new compounds and evaluate their benefits over current treatments.
- ||| difamilast (MM36) / Otsuka, Medimetriks
P3 data, Journal: Difamilast Ointment in Japanese Adult and Pediatric Patients with Atopic Dermatitis: A Phase III, Long-Term, Open-Label Study. (Pubmed Central) - Jun 22, 2022
P3
However, longer and larger prospective studies are needed to assess the long-term efficacy and safety of these new compounds and evaluate their benefits over current treatments. This study demonstrates that difamilast ointments are well tolerated and effective in Japanese adult and pediatric patients with AD when applied twice daily for 52 weeks, and are expected to be used for a long-term treatment for AD.
- |||| Moizerto (difamilast) / Otsuka, Medimetriks
New P3 trial: A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis (clinicaltrials.gov) - May 12, 2022
P3, N=40, Recruiting, Sponsor: Otsuka Pharmaceutical Co., Ltd.
- ||| difamilast (MM36) / Otsuka, Medimetriks
Clinical, P3 data, Journal: Difamilast ointment in adult patients with atopic dermatitis: A phase 3 randomized double-blind vehicle-controlled trial. (Pubmed Central) - Apr 15, 2022
This study demonstrates that difamilast ointments are well tolerated and effective in Japanese adult and pediatric patients with AD when applied twice daily for 52 weeks, and are expected to be used for a long-term treatment for AD. Difamilast 1% ointment demonstrates superiority to vehicle and favorable safety in Japanese adult AD patients.
- ||| difamilast (MM36) / Otsuka, Medimetriks
Clinical, P3 data, Journal: Difamilast ointment, a selective phosphodiesterase 4 inhibitor, in paediatric patients with atopic dermatitis: A phase 3 randomised double-blind, vehicle-controlled trial. (Pubmed Central) - Mar 4, 2022
Difamilast 1% ointment demonstrates superiority to vehicle and favorable safety in Japanese adult AD patients. Difamilast 0·3% and 1% ointments are superior to vehicle and well tolerated in Japanese paediatric patients with AD.
- ||||||| difamilast (MM36) / Otsuka, Medimetriks
Trial completion: Long-term Trial of OPA-15406 Ointment in Adult and Pediatric Patients With Atopic Dermatitis (clinicaltrials.gov) - May 19, 2021
P3, N=366, Completed, Sponsor: Otsuka Pharmaceutical Co., Ltd.
Difamilast 0·3% and 1% ointments are superior to vehicle and well tolerated in Japanese paediatric patients with AD. Recruiting --> Completed
- ||||| difamilast (MM36) / Otsuka, Medimetriks
Clinical, P3 data, Adverse events: 3/ Difamilast, a topical PDE4 inhibitor for atopic #eczema - phase 3 trials in adult Japanese patients 38.5% IGA0/1; 58.2% EASI50; 42.9% EASI75 at week 4 Higher numbers in paediatric patients; few adverse effects Not bad, probably < effective than topical JAKs ? h2h v Protopic (Twitter) - Apr 25, 2021
- difamilast (MM36) / Otsuka, Medimetriks
[VIRTUAL] Difamilast a topical PDE4 inhibitor: Phase 3 trials in Japanese Adult and pediatric patients with Atopic dermatitis. () - Apr 10, 2021 - Abstract #AADVMX2021AAD_VMX_310;
P3
The incidence of treatment-emergent adverse events in the difamilast were not higher than in the vehicle. Conclusion Difamilast ointment significantly improved signs and symptoms of AD, and showed favorable safety profiles.
- || difamilast (MM36) / Otsuka, Medimetriks
Clinical, P2 data, Journal: Phase 2, randomized, double-blind, placebo-controlled, 4-week study to evaluate the safety and efficacy of OPA- 15406 (difamilast), a new topical selective phosphodiesterase type-4 inhibitor, in Japanese pediatric patients aged 2-14 years with atopic dermatitis. (Pubmed Central) - Sep 27, 2020
The OPA-15406 groups also showed greater improvements from baseline compared with the vehicle group in the Investigator Global Assessment score, Eczema Area and Severity Index overall score and subscale (erythema, induration/papulation, excoriation and lichenification) scores, Visual Analog Scale pruritus score, Patient-Oriented Eczema Measure score, and percentage of affected body surface area over the 4-week study. Topical OPA-15406 twice daily for 4 weeks was considered a safe and effective treatment option in this phase 2 study in pediatric patients with atopic dermatitis, and phase 3 development is currently ongoing.
- [VIRTUAL] Advances and future developments in the treatment of atopic dermatitis (p.609) - Aug 2, 2020 - Abstract #WAC2020WAC_224;
Or we are applying. In the future, it is expected that new therapeutic drugs will be covered by insurance and the range of AD treatment will expand.
- ||||||| difamilast (MM36) / Otsuka, Medimetriks
Trial completion, Head-to-Head: Comparison Trial of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis (clinicaltrials.gov) - May 14, 2020
P3, N=251, Completed, Sponsor: Otsuka Pharmaceutical Co., Ltd.
In the future, it is expected that new therapeutic drugs will be covered by insurance and the range of AD treatment will expand. Recruiting --> Completed
- ||||||| difamilast (MM36) / Otsuka, Medimetriks
Trial completion, Head-to-Head: Comparison Trial of OPA-15406 Ointment in Adult Patients With Atopic DermatitisSyndrome (clinicaltrials.gov) - Feb 28, 2020
P3, N=364, Completed, Sponsor: Otsuka Pharmaceutical Co., Ltd.
Recruiting --> Completed Recruiting --> Completed
- |||||||||| difamilast (MM36) / Otsuka, Medimetriks
New P3 trial: Long-term Trial of OPA-15406 Ointment in Adult and Pediatric Patients With Atopic Dermatitis (clinicaltrials.gov) - May 23, 2019
P3, N=330, Recruiting, Sponsor: Otsuka Pharmaceutical Co., Ltd.
- |||||||||| difamilast (MM36) / Otsuka, Medimetriks
New P3 trial, Head-to-Head: Comparison Trial of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis (clinicaltrials.gov) - Apr 11, 2019
P3, N=240, Recruiting, Sponsor: Otsuka Pharmaceutical Co., Ltd.
- |||||||||| difamilast (MM36) / Otsuka, Medimetriks
New P3 trial, Head-to-Head: Comparison Trial of OPA-15406 Ointment in Adult Patients With Atopic DermatitisSyndrome (clinicaltrials.gov) - Apr 9, 2019
P3, N=340, Recruiting, Sponsor: Otsuka Pharmaceutical Co., Ltd.
- | difamilast (MM36) / Otsuka, Medimetriks
Trial completion: Pharmacokinetics and Safety of MM36 Topical Ointment in Pediatric Subjects With Atopic Dermatitis (clinicaltrials.gov) - Aug 30, 2017
P2, N=32, Completed, Sponsor: Medimetriks Pharmaceuticals, Inc
Recruiting --> Completed Active, not recruiting --> Completed
- |||| difamilast (MM36) / Otsuka, Medimetriks
Trial completion, Enrollment change: Phase 2 Study of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis (clinicaltrials.gov) - Jul 17, 2017
P2, N=73, Completed, Sponsor: Otsuka Pharmaceutical Co., Ltd.
Active, not recruiting --> Completed Active, not recruiting --> Completed | N=60 --> 73
- |||| difamilast (MM36) / Otsuka, Medimetriks
Trial completion: Study of OPA-15406 Ointment in Patients With Atopic Dermatitis (clinicaltrials.gov) - Jul 17, 2017
P2, N=200, Completed, Sponsor: Otsuka Pharmaceutical Co., Ltd.
Active, not recruiting --> Completed | N=60 --> 73 Recruiting --> Completed
- || difamilast (MM36) / Otsuka, Medimetriks
Trial primary completion date: Phase 2 Study of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis (clinicaltrials.gov) - Jul 6, 2017
P2, N=60, Active, not recruiting, Sponsor: Otsuka Pharmaceutical Co., Ltd.
Recruiting --> Completed Trial primary completion date: Dec 2017 --> Aug 2017
- ||| difamilast (MM36) / Otsuka, Medimetriks
Enrollment closed, Trial primary completion date: Phase 2 Study of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis (clinicaltrials.gov) - Jun 27, 2017
P2, N=60, Active, not recruiting, Sponsor: Otsuka Pharmaceutical Co., Ltd.
Trial primary completion date: Dec 2017 --> Aug 2017 Recruiting --> Active, not recruiting | Trial primary completion date: Aug 2017 --> Dec 2017
- | difamilast (MM36) / Otsuka, Medimetriks
Enrollment closed: Pharmacokinetics and Safety of MM36 Topical Ointment in Pediatric Subjects With Atopic Dermatitis (clinicaltrials.gov) - Jun 21, 2017
P2, N=32, Active, not recruiting, Sponsor: Medimetriks Pharmaceuticals, Inc
Recruiting --> Active, not recruiting | Trial primary completion date: Aug 2017 --> Dec 2017 Recruiting --> Active, not recruiting
- | difamilast (MM36) / Otsuka, Medimetriks
Journal: OPA-15406, a novel, topical, nonsteroidal, selective phosphodiesterase-4 (PDE4) inhibitor, in the treatment of adult and adolescent patients with mild to moderate atopic dermatitis (AD): A phase-II randomized, double-blind, placebo-controlled study. (Pubmed Central) - Apr 13, 2017
Recruiting --> Active, not recruiting OPA-15406 ointment may provide an effective therapeutic modality for patients with mild to moderate AD.
- ||||| difamilast (MM36) / Otsuka, Medimetriks
New P2 trial: Phase 2 Study of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis (clinicaltrials.gov) - Jan 12, 2017
P2, N=60, Recruiting, Sponsor: Otsuka Pharmaceutical Co., Ltd.
- | difamilast (MM36) / Otsuka, Medimetriks
Enrollment open: Pharmacokinetics and Safety of MM36 Topical Ointment in Pediatric Subjects With Atopic Dermatitis (clinicaltrials.gov) - Nov 25, 2016
P2, N=32, Recruiting, Sponsor: Medimetriks Pharmaceuticals, Inc
OPA-15406 ointment may provide an effective therapeutic modality for patients with mild to moderate AD. Not yet recruiting --> Recruiting
- | difamilast (MM36) / Otsuka, Medimetriks
New P2 trial: Pharmacokinetics and Safety of MM36 Topical Ointment in Pediatric Subjects With Atopic Dermatitis (clinicaltrials.gov) - Oct 26, 2016
P2, N=32, Not yet recruiting, Sponsor: Medimetriks Pharmaceuticals, Inc
- ||||| difamilast (MM36) / Otsuka, Medimetriks
New P2 trial: Study of OPA-15406 Ointment in Patients With Atopic Dermatitis (clinicaltrials.gov) - Sep 26, 2016
P2, N=180, Recruiting, Sponsor: Otsuka Pharmaceutical Co., Ltd.
- | difamilast (MM36) / Otsuka, Medimetriks
Trial completion: A Phase 1 Trial of OPA-15406 Ointment in Healthy Adult Male Subjects (clinicaltrials.gov) - Aug 13, 2015
P1, N=32, Completed, Sponsor: Otsuka Pharmaceutical Co., Ltd.
Not yet recruiting --> Recruiting Recruiting --> Completed