An Open Label Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam as a Mono or add-on Therapy in the Treatment of Hidradenitis Suppurativa With Correlative Analysis.

This is a phase 2a, open label study.
As psoriasis and Hidradenitis Suppurativa (HS) share multiple inflammatory pathways, the investigators hypothesize that the use of topical roflumilast 0.3% foam is a safe and efficacious option as a monotherapy for patients with mild disease and as add-on therapy for maintenance and flares in patients with moderate to severe disease. The study will include correlative analysis to study gene expression profiling before and after therapy.

Start Date01 Sep 2025

Sponsor / Collaborator

Arcutis Biotherapeutics, Inc.

NCT07233291

/ RecruitingPhase 2IIT

Evaluation of Efficacy and Safety of Oral Roflumilast in Treatment of Moderate to Severe Psoriasis: a Pilot Study

This is a 12-week, single-arm, open-label pilot study to assess the safety and preliminary efficacy of oral roflumilast in adults with moderate-to-severe plaque psoriasis. All participants, both male and female, will receive oral roflumilast starting at 250 mcg once daily for 10 days, followed by 500 mcg once daily for the remainder of the study. The primary outcome is the mean change in Psoriasis Area and Severity Index (PASI) score from baseline to Week 12. Secondary outcomes include change in body mass index (BMI) and safety assessments, including treatment-emergent adverse events, serious adverse events, and laboratory abnormalities. Male and female participants will be analyzed as subgroups.

Start Date20 Aug 2025

Sponsor / Collaborator

Mansoura University Hospital

[+1]

100 Clinical Results associated with Roflumilast

100 Translational Medicine associated with Roflumilast

100 Patents (Medical) associated with Roflumilast

1,122

Literatures (Medical) associated with Roflumilast

01 Jan 2026·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Identification of a novel PDE4 inhibitor inspired by leoligin-derived lignans

Article

Author: Mihovilovic, Marko D ; Dirsch, Verena M ; Chen, Ya ; Richter, Wito ; Perhal, Alexander F ; Kirchmair, Johannes ; Coffey, Christine ; Schwaiger, Stefan ; Linder, Thomas ; Schnürch, Michael

The phosphodiesterase 4 (PDE4) family comprises isoenzymes that selectively hydrolyse the second messenger cyclic adenosine monophosphate (cAMP). PDE4s are widely expressed and play key roles in various physiologic paradigms, including immune responses, memory, cognition, and metabolism. Marketed PDE4 inhibitors, such as roflumilast and apremilast, treat chronic obstructive pulmonary disease and psoriasis. Identification and characterisation of PDE4 inhibitors offer a promising strategy for targeting diverse pathological processes. In this study, leoligin, a natural lignan found in the roots of Edelweiss (Leontopodium nivale subsp. alpinum (Cass.) Greuter (Asteraceae)) and 165 analogues were screened for their PDE inhibitory activity using a cAMP accumulation assay employing an exchange protein activated by cAMP-based biosensor. Six compounds, including leoligin itself, were identified to cause a significant accumulation of cAMP, and structure-activity relationships were deduced. One analogue, designated LT-104A, showed a concentration-dependent activity with the highest determined potency (EC₅₀ = 1.9 μM) in the cAMP accumulation assay. LT-104A was further characterised using a CRE-Luciferase assay, showing comparable activity to known PDE4 inhibitors in inducing the anti-inflammatory cAMP-PKA-CREB pathway. The inhibitory activity of LT-104A was also confirmed against recombinant PDE4D3 in a cell-free cAMP hydrolysis assay (IC₅₀ = 9.3 μM). The potential binding mode of LT-104A with the catalytic domain of PDE4D was predicted using induced-fit docking. Lastly, a functional study was conducted in LPS-activated macrophages, where LT-104A reduced nitric oxide release and decreased mRNA expression of Il1b and Nos2. In conclusion, extensive in vitro screening of leoligin analogues led to the identification and characterisation of a novel PDE4 inhibitor, LT-104A, with potential in vitro anti-inflammatory properties.

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Oral roflumilast for psoriasis: a real-world 24-week prospective cohort study

Article

Author: Yilmaz, Orhan ; Torres, Tiago ; Lé, Ana Maria ; Luz, Martim

OBJECTIVE:

Psoriasis is a chronic inflammatory skin disease with significant physical and psychological burden, often associated with comorbidities such as obesity and cardiovascular disease. Current treatments include conventional systemic therapies and targeted biologic and non-biologic therapies, with several limitations related to safety, efficacy, and cost. Roflumilast, a selective PDE4 inhibitor, shows potential as an oral therapy for psoriasis due to its anti-inflammatory effects and favorable safety profile. This study aimed to evaluate the real-world effectiveness and safety of oral roflumilast in moderate-to-severe plaque psoriasis.

METHODS:

Prospective cohort study at a single center in Portugal including adults with moderate-to-severe psoriasis treated with oral roflumilast 500 mcg once daily.

RESULTS:

Among fifty-eight patients (baseline median PASI 13.7 ± 5.5), 63.0% achieved PASI < 5, 47.8% PASI < 3, and 21.7% PASI < 1 by week 24 (mNRI). Weight loss occurred in 53.4%, with a mean reduction of 6 kg ± 4.3. Mild gastrointestinal symptoms were common but rarely caused discontinuation. No serious adverse events were reported.

CONCLUSION:

Roflumilast demonstrated real-world effectiveness and a favorable safety profile in moderate-to-severe plaque psoriasis. Additional benefits, including weight loss and no need for laboratory monitoring, make it a promising treatment option, particularly for patients with comorbidities or limited access to biologic therapies.

01 Dec 2025·INFLAMMATION RESEARCH

Selective phosphodiesterase 4 inhibitor roflumilast reduces inflammation and lung injury in models of betacoronavirus infection in mice

Article

Author: Lacerda, Larisse de Souza Barbosa ; da Silva, Walison Nunes ; Martins, Débora Gonzaga ; Martins, Flávia Rayssa Braga ; Soriani, Frederico Marianetti ; Guimaraes, Pedro Pires Goulart ; Pinho, Vanessa ; Costa, Vivian Vasconcelos ; Félix, Franciel Batista ; Teixeira, Mauro Martins ; Costa, Victor Rodrigues de Melo ; Beltrami, Vinícius Amorim ; Queiroz-Junior, Celso Martins ; Santos, Felipe Rocha da Silva ; Resende, Letícia Cassiano ; Guimaraes, Goulart

OBJECTIVE:

We aimed to understand the potential therapeutic and anti-inflammatory effects of the phosphodiesterase-4 (PDE4) inhibitor roflumilast in models of pulmonary infection caused by betacoronaviruses.

METHODS:

Mice were infected intranasally with murine hepatitis virus (MHV-3) or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Roflumilast was given to MHV-3-infected mice therapeutically at doses of 1 mg/kg or 10 mg/kg, or prophylactically at 10 mg/kg. In SARS-CoV-2-infected mice, roflumilast was given therapeutically at a dose of 10 mg/kg. Lung histopathology, chemokines (CXCL-1 and CCL2), cytokines (IL-1β, IL-6, TNF, IFN-γ, IL-10 and TGFβ), neutrophil immunohistochemical staining (Ly6G⁺ cells), macrophage immunofluorescence staining (F4/80⁺ cells), viral titration plaque assay, real-time PCR virus detection, and blood cell counts were examined.

RESULTS:

Therapeutic treatment with roflumilast at 10 mg/kg reduced lung injury in SARS-CoV-2 or MHV-3-infected mice without compromising viral clearance. In MHV-3-infected mice, reduced lung injury was associated with decreased chemokines levels, prevention of neutrophil aggregates and reduced macrophage accumulation in the lung tissue. However, the prophylactic treatment strategy with roflumilast increased lung injury in MHV-3-infected mice.

CONCLUSION:

Our findings indicate that therapeutic treatment with roflumilast reduced lung injury in MHV-3 and SARS-CoV-2 lung infections. Given the protection induced by roflumilast in inflammation, PDE4 targeting could be a promising therapeutic avenue worth exploring following severe viral infections of the lung.

208

News (Medical) associated with Roflumilast

08 Dec 2025

·investors.arcutis.com

Arcutis Strengthens Board of Directors with New Appointment of Amit Munshi and Honors Retirement of Bhaskar Chaudhuri

WESTLAKE VILLAGE, Calif., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that Amit Munshi has been appointed to the Arcutis Board of Directors effective December 4, 2025, and announced the retirement of founder and long-serving Board member Bhaskar Chaudhuri, PhD. Dr. Chaudhuri will continue as a consultant for the Company. “As Arcutis looks to continue to grow in this next chapter, we are delighted to welcome Amit, an exceptional and visionary biopharmaceutical leader, to the Arcutis Board,” said Frank Watanabe, president and chief executive officer of Arcutis. “Amit’s deep expertise in financing, portfolio optimization, and strategic corporate transactions—combined with his experience advising diverse biotech companies and leading investment firms—will be invaluable for Arcutis as we broaden commercialization of ZORYVE® (roflumilast), advance our expanding pipeline, and reinforce our leadership in medical dermatology.” “As one of the founders of Arcutis, our former chairman, and member of the board for nine years, Bhaskar has been instrumental in the successful development of ZORYVE—now the number one prescribed branded topical across three indications—and the growth of Arcutis from the first Series A financing to a now multibillion-dollar market cap company,” said Keith R. Leonard, chairman of the Board of Arcutis. “We are deeply grateful and thank him for his vision, dedication, and significant contributions in shaping what Arcutis is today.” “Arcutis is entering a significant phase of growth, evolving its commercial presence and progress, and building an innovative pipeline that addresses real unmet needs,” said Amit Munshi. “I’m honored to join the Board and contribute my experience to support the Company as it strengthens its foundation, extends its impact, and brings forward meaningful solutions for people with chronic skin conditions.” Amit Munshi is a proven biopharmaceutical leader with a track record of transforming companies and driving multibillion-dollar outcomes. Most recently, as president and CEO of Orna Therapeutics LLC, he spearheaded the merger of Orna and ReNAgade Therapeutics LLC, as well as its Series A financing and operational build-out. Previously, as CEO of Arena Pharmaceuticals, Inc., he led a dramatic turnaround, which included revamping the Company’s strategy and raising over $900M in equity and $800M in partnerships, and culminated in Pfizer’s $6.7B acquisition, in addition to progressing four therapeutics in 11 indications with 37 trials at 600+ clinical sites around the world. Munshi serves on multiple boards, advises leading investment firms and has also held leadership roles at EPIRUS Biopharmaceuticals, Inc., Percivia LLC, Kythera Biopharmaceuticals, Inc. and Amgen Inc., where he drove global launches, optimized product portfolios, and led strategic transactions. He holds an MBA from Claremont Graduate University and dual degrees from The University of California, Riverside. About ArcutisArcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases. Arcutis’ unique dermatology development platform, coupled with our dermatology expertise, allows us to develop differentiated therapies against biologically validated targets, and has produced a robust pipeline for a range of inflammatory dermatological conditions. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram, and X. INDICATIONSZORYVE cream, 0.05%, is indicated for topical treatment of mild to moderate atopic dermatitis in pediatric patients 2 to 5 years of age. ZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. ZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older. ZORYVE topical foam, 0.3%, is indicated for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older. ZORYVE topical foam, 0.3%, is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older. IMPORTANT SAFETY INFORMATION ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C). Flammability: The propellants in ZORYVE foam are flammable. Avoid fire, flame, and smoking during and immediately following application. The most common adverse reactions reported (≥1%) for ZORYVE cream 0.05% for pediatric patients with atopic dermatitis 2 to 5 years of age were upper respiratory tract infection (4.1%), diarrhea (2.5%), vomiting (2.1%), rhinitis (1.6%), conjunctivitis (1.4%), and headache (1.1%). The most common adverse reactions reported (≥1%) for ZORYVE cream 0.15% for patients with atopic dermatitis 6 years of age or older were headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%). The most common adverse reactions reported (≥1%) for ZORYVE cream 0.3% for plaque psoriasis were diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%). The most common adverse reactions reported (≥1%) for ZORYVE foam 0.3% for plaque psoriasis were headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%). The most common adverse reactions reported (≥1%) for ZORYVE foam 0.3% for seborrheic dermatitis were nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%). Please see full Prescribing Information for ZORYVE cream and full Prescribing Information for ZORYVE foam. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the Company’s financial position and potential growth. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 25, 2025, as well as any subsequent filings with the SEC. Any forward-looking statements that the Company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Contacts:MediaAmanda Sheldon, Head of Corporate Communicationsmedia@arcutis.com InvestorsBrian Schoelkopf, Head of Investor Relationsir@arcutis.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/9ecc2657-94a4-424c-9221-6ec36bbd15ca

Executive ChangeAcquisitionDrug Approval

17 Nov 2025

·investors.arcutis.com

FDA Accepts Supplemental New Drug Application for Arcutis’ ZORYVE® (roflumilast) Cream 0.3% for the Treatment of Plaque Psoriasis in Children Ages 2 to 5

Prescription Drug User Fee Act (PDUFA) target action date set for June 29, 2026 If approved, ZORYVE cream 0.3% would be the first and only topical PDE4 inhibitor indicated for plaque psoriasis in children as young as 2 WESTLAKE VILLAGE, Calif., Nov. 17, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the FDA acceptance of a supplemental New Drug Application (sNDA) for ZORYVE® (roflumilast) cream 0.3%, a once-daily, advanced targeted topical phosphodiesterase-4 (PDE4) inhibitor, to expand the indication for the topical treatment of plaque psoriasis to include children 2 to 5 years old. The FDA has set a PDUFA target action date of June 29, 2026, for this application. “Plaque psoriasis in young children can be particularly challenging to manage, as it often affects sensitive areas such as the face and intertriginous skin,” said Amy Paller, MS, MD, attending physician, dermatology, Walter J. Hamlin Professor and chair of dermatology, professor of pediatrics, Northwestern University Feinberg School of Medicine. “Effective and well-tolerated treatment options that are gentle enough for these areas are critical to support long-term disease control and improve quality of life for children and their families.” “This milestone brings us closer to helping families and clinicians caring for young children with plaque psoriasis,” said Frank Watanabe, president and CEO of Arcutis. “If approved, ZORYVE cream 0.3% would be the first and only topical PDE4 inhibitor indicated for children as young as two, offering a steroid-free option that delivers both efficacy and tolerability for this particularly vulnerable group. We remain deeply committed to advancing care for people of all ages living with immune-mediated skin diseases, offering innovative, advanced targeted topicals to elevate the standard of care—including children as young as age two.” ZORYVE cream 0.3% is currently approved for plaque psoriasis in adults and children down to age 6. This sNDA is supported by data from a 4-week Maximal Usage Systemic Exposure (MUSE) study in children aged 2 to 5 years with plaque psoriasis, as well as data from a long-term open-label study that included children in that age range. Results from this long-term study demonstrate consistent favorable long-term safety and tolerability as well as persistence of efficacy across all age ranges studied. About Plaque Psoriasis Psoriasis is a common, chronic, inflammatory skin disease that affects nearly 9 million people in the United States. Symptoms include itch, scaling, redness, flaking, and pain. On darker skin tones, plaques may appear more grayish, purplish, or brown. Psoriasis can appear anywhere on the body, including the knees, elbows, torso and thin-skinned areas like the face, genitals and intertriginous areas, which are areas where skin touches skin, such as the armpits, under the breasts, stomach folds, between the buttocks, and in the groin. In children, psoriasis more commonly affects these sensitive areas and intertriginous regions, posing treatment challenges and quality-of-life burdens for patients and families. About ZORYVE® (roflumilast) ZORYVE is the number one prescribed branded topical therapy across three major inflammatory dermatoses combined—atopic dermatitis, seborrheic dermatitis, and plaque psoriasis. ZORYVE cream is a topical formulation of roflumilast, an advanced targeted topical phosphodiesterase type 4 (PDE4) inhibitor. Inhibiting PDE4, an intracellular enzyme that is an established target in dermatology, decreases the production of pro-inflammatory mediators. This decreases inflammation in the skin and balances the skin’s immune system. Demonstrating both clinical impact and broad industry recognition, ZORYVE has been honored with multiple prestigious awards and recommendations. ZORYVE was recently awarded by Allure with the "2025 Best of Beauty Breakthrough Award," making it the first FDA-approved medication for atopic dermatitis, plaque psoriasis, and seborrheic dermatitis to win this prominent award. ZORYVE cream 0.3% and ZORYVE foam 0.3% were also awarded the National Psoriasis Foundation’s Seal of Recognition—the first FDA-approved prescription brand to receive the honor. Additionally, the American Academy of Dermatology (AAD) issued a strong recommendation for the use of ZORYVE cream 0.15% in adult patients with mild to moderate atopic dermatitis, according to updated guidelines released in June 2025. In 2024, ZORYVE cream 0.15% was awarded Glamour’s Beauty and Wellness Award for “Best Eczema Product.” About ArcutisArcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases. Arcutis’ unique dermatology development platform coupled with our dermatology expertise allows us to develop differentiated therapies against biologically validated targets, and has produced a robust pipeline for a range of inflammatory dermatological conditions. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram, and X. INDICATIONSZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older. IMPORTANT SAFETY INFORMATION ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C). The most common adverse reactions reported (≥1%) for ZORYVE cream 0.3% for plaque psoriasis were diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%). Please see full Prescribing Information for ZORYVE cream. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential FDA approval of ZORYVE cream 0.3% for plaque psoriasis for children ages 2 to 5 years, and the potential of ZORYVE cream to advance the standard of care for plaque psoriasis and other inflammatory dermatological conditions. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 25, 2025, as well as any subsequent filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Contacts:MediaAmanda Sheldon, Head of Corporate Communicationsmedia@arcutis.com InvestorsBrian Schoelkopf, Head of Investor Relationsir@arcutis.com

Drug Approval

14 Nov 2025

·firstwordpharma.com

CHMP roundup: Merck & Co.'s newly acquired Verona pulls EU filing for COPD drug mid-review

Barely a month after joining Merck & Co. through a $10-billion merger, Verona Pharma has withdrawn its EU marketing application for Ohtuvayre (ensifentrine), the inhaled PDE3/4 inhibitor touted as a key addition to Merck's cardio-pulmonary portfolio. The filing was pulled on Oct. 30 as the European Medicines Agency (EMA) was still evaluating initial information from the company, leaving the review process unfinished and without any recommendations from the regulator. Ohtuvayre was approved in the US last year for maintenance treatment of chronic obstructive pulmonary disease (COPD), supported by two Phase III trials demonstrating significant lung function improvements in patients with moderate-to-severe illness. Review of priorities However, the studies did not enroll COPD patients exacerbating on triple therapy, a group where some pulmonologists think it is likely to be used most often. In a recent FirstWord interview, one key opinion leader (KOL) described Ohtuvayre as effective and meaningfully safer than roflumilast, but suggested that this data gap in triple-therapy patients was likely to impact how often it will be used. For more, see – KOL Views Q&A: Leading expert impressed by Ohtuvayre but sees one feature weighing on use in COPD. According to the EMA, Verona stated that it withdrew the Ohtuvayre application "following a review of its priorities." Positive recommendations While Ohtuvayre's EU prospects appear to be on pause, the EMA's Committee for Medicinal Products for Human Use (CHMP) issued a number of positive opinions for other therapies on Friday. Nearly three months after getting the all-clear in the US, Ionis and Otsuka's Dawnzera (donidalorsen) received a CHMP recommendation for routine prevention of recurrent hereditary angioedema attacks in adults and adolescents aged 12 and older. The RNA-targeting prophylactic, administered subcutaneously once a month, is backed by Phase III data from the OASIS-HAE study showing it led to a mean 81% reduction in HAE attacks versus placebo. Otsuka holds exclusive rights to market Dawnzera across Europe and the Asia-Pacific region. CHMP also issued a positive opinion for Eli Lilly's Inluriyo (imlunestrant), an oral selective oestrogen receptor degrader (SERD) aimed at adult patients with locally advanced or metastatic breast cancer and an activating ESR1-mutation. The drug was approved by US regulators in September based on data from the Phase III EMBER-3 trial showing it lowered the risk of progression or death by 38% over standard endocrine therapy in ESR1-mutant patients. The risk-reduction rate ticked up to 43% when Inluriyo was given alongside Lilly's CDK4/6 inhibitor Verzenio (abemaciclib), compared to SERD alone (see – KOL Views Q&A: Battle for oral SERD supremacy in HR+ breast cancer boils down to efficacy). Sanofi's Teizeild (teplizumab) secured a favourable recommendation as a therapy intended to preserve beta-cell function and delay progression to stage 3 type 1 diabetes (T1D) in adults and children 8 years and older with stage 2 disease. In clinical testing, median time to onset of stage 3 T1D was 49.5 months with Teizeild versus 24.9 months for placebo. Sanofi gained the drug — marketed in the US as Tzield and approved there three years ago — through its nearly $3 billion takeout of Provention Bio in 2023. Meanwhile, Waskyra (etuvetidigene autotemcel) became the first gene therapy to receive a positive CHMP opinion for Wiskott-Aldrich syndrome, a rare immunodeficiency that almost exclusively affects males and can lead to bleeding problems and eczema as well as susceptibility to infections. Data from a clinical development programme involving 27 patients showed that Waskyra reduced both severe infections (from 2.0 to 0.12 annual events by years 2-3) and moderate-to-severe bleeding episodes (from 2.0 to 0.16 annual events by years 2-3) compared to pre-treatment rates. If authorised, Waskyra would offer an alternative for patients who are candidates for stem-cell transplantation, but lack suitable donors. The applicant is Fondazione Telethon ETS, which also submitted a filing to the FDA earlier this year. Anavex craters The news was less upbeat for Anavex Life Sciences, however, after EU regulators delivered a negative trend vote on its marketing application for blarcamesine in early Alzheimer's disease, signaling that the agency is likely to issue an unfavourable opinion when it meets in December. According to Anavex, the orally available drug candidate is designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors. The regulatory setback triggered a sharp investor reaction, with Anavex shares falling roughly 38% on Friday. The company says it plans to seek a formal re-examination once the opinion is formally adopted, a process that would shift review to a separate CHMP panel and allow Anavex to submit additional biomarker analyses. The EU filing included data from the Phase IIb/III ANAVEX2-73-AD-004 trial showing that once-daily oral blarcamesine slowed clinical progression by 36.3% at 48 weeks — and by nearly 50% in patients with the prespecified SIGMAR1 wild-type genotype — on the primary ADAS-Cog13 cognitive measure. Separately, Anavex said Friday that the FDA has advised the company to schedule a meeting to discuss clinical results from its Alzheimer's trials.

Clinical ResultPhase 3Drug Approval

100 Deals associated with Roflumilast

External Link

KEGG	Wiki	ATC	Drug Bank
D05744	Roflumilast	R03DX07	DB01656

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Dermatitis, Atopic	United States	Arcutis Biotherapeutics, Inc.	10 Jul 2024
Dermatitis, Seborrheic	United States	Arcutis Biotherapeutics, Inc.	15 Dec 2023
Plaque psoriasis	Canada	Arcutis Biotherapeutics, Inc.	20 Dec 2019
Pulmonary Disease, Chronic Obstructive	European Union	AstraZeneca AB	05 Jul 2010
Pulmonary Disease, Chronic Obstructive	Iceland	AstraZeneca AB	05 Jul 2010
Pulmonary Disease, Chronic Obstructive	Liechtenstein	AstraZeneca AB	05 Jul 2010
Pulmonary Disease, Chronic Obstructive	Norway	AstraZeneca AB	05 Jul 2010

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Mild Atopic Dermatitis	Phase 3	China	Arcutis Biotherapeutics, Inc.	21 Nov 2024
Mild Atopic Dermatitis	Phase 3	China	Hangzhou Zhongmeihuadong Pharmaceutical Co., Ltd.	21 Nov 2024
Moderate Atopic Dermatitis	Phase 3	China	Hangzhou Zhongmeihuadong Pharmaceutical Co., Ltd.	21 Nov 2024
Moderate Atopic Dermatitis	Phase 3	China	Arcutis Biotherapeutics, Inc.	21 Nov 2024
Psoriasis of scalp	Phase 3	United States	Arcutis Biotherapeutics, Inc.	24 Aug 2021
Psoriasis of scalp	Phase 3	Canada	Arcutis Biotherapeutics, Inc.	24 Aug 2021
Chronic large plaque psoriasis	Phase 3	United States	Arcutis Biotherapeutics, Inc.	12 Feb 2020
Chronic large plaque psoriasis	Phase 3	Canada	Arcutis Biotherapeutics, Inc.	12 Feb 2020
Chronic large plaque psoriasis	Phase 3	Dominican Republic	Arcutis Biotherapeutics, Inc.	12 Feb 2020
Asthma	Phase 3	United States	AstraZeneca PLC	01 Nov 2003

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04211363 \| NCT04211389 (DERMIS-1, Pubmed \| Dermatol Ther (Heidelb))	Phase 3	Plaque psoriasis	398	Roflumilast cream 0.3%	gfylflwjcj(lsvavktauv) = lsvxgzrzak lhtlhsfjuq (kyvebmivrb ) View more	Positive	24 Oct 2025
				Vehicle	gfylflwjcj(lsvavktauv) = ghfdadbhur lhtlhsfjuq (kyvebmivrb ) View more
NCT04211363 \| NCT04211389 \| NCT05028582 (ARRECTOR, Company_Website) Manual	Phase 3	Plaque psoriasis	-	ZORYVE cream 0.3%	luiptyzlnh(mltoeoayfg) = Data from the Phase 3 DERMIS-1/2 and ARRECTOR trials demonstrated that, at Week 8, ZORYVE cream 0.3% and ZORYVE foam 0.3% both improved signs and symptoms of plaque psoriasis in individuals with facial and/or genital involvement. Improvements in subgroups with facial and/or genital involvement were comparable with those in the overall population and consistent between the cream and foam formulations. bohhgzxijl (lhzxjdkiok ) View more	Positive	17 Sep 2025
				ZORYVE foam 0.3%
NCT04845620 (INTEGUMENT-PED, Company_Website) Manual	Phase 3	Dermatitis, Atopic	-	ZORYVE cream 0.05%	hamshrethk(woheqlkknv) = Children who received a once-daily application of ZORYVE cream 0.05% had greater improvements versus vehicle across various PROs assessing signs and symptoms of atopic dermatitis after 4 weeks. Improvements were observed in SCORing Atopic Dermatitis (SCORAD) total and component scores (i.e., itch, sleep loss, and dryness intensity). svtxliyriz (rstixusspv ) View more	Positive	17 Sep 2025
				Vehicle
NCT04973228 (STRATUM, Company_Website) Manual	Phase 3	Dermatitis, Seborrheic	-	ZORYVE foam 0.3%	buxtcutndf(xngsbhirit) = dgbvghamwv kbueciyshv (qneyuryuza ) View more	Positive	17 Sep 2025
				Vehicle	buxtcutndf(xngsbhirit) = byggdigyim kbueciyshv (qneyuryuza ) View more
NCT06631170 (NEWS) Manual	Phase 3	Moderate Atopic Dermatitis \| Dermatitis, Atopic	354	0.15%罗氟司特	vxfxflbfsj(nuhtuctidh) = kspoukcfwd fgiibkafsx (jdnbgluyos ) Met View more	Positive	30 Jul 2025
				赋形剂	vxfxflbfsj(nuhtuctidh) = jleqavnbxs fgiibkafsx (jdnbgluyos ) Met View more
NCT05028582 (ARRECTOR, CTgov)	Phase 3	Psoriasis of scalp	432	Roflumilast Foam 0.3% (Roflumilast Foam 0.3%)	abzsrqeuja = yeqhhtjtdq ohsddghzlx (kuotezfkff, irmggawujg - mvtcuzgxqm) View more	-	17 Jul 2025
				Vehicle Foam (Vehicle Foam)	abzsrqeuja = ozuqbuiaqn ohsddghzlx (kuotezfkff, ecagyndbby - knwtofrksn) View more
NCT05028582 (ARRECTOR, AAD2025) Manual	Phase 3	Psoriasis	432	roflumilast foam 0.3%roflumilast foam 0.3%	bujfegqgdt(qbklpeveda) = uarxglqxbi zjzokmgwmx (ukljcnhjmx ) View more	Positive	07 Mar 2025
				vehicle	bujfegqgdt(qbklpeveda) = piygbelsnf zjzokmgwmx (ukljcnhjmx ) View more
NCT04773587 \| NCT04773600 (INTEGUMENT-2, AAD2025 \| Company_Website) Manual	Phase 3	Dermatitis, Atopic	1,337	Roflumilast creamRoflumilast cream 0.15%	czqdnuagyt(mersnvniby) = hvfyaiswgl moxyayhrme (unnbmkjgys ) View more	Positive	07 Mar 2025
				Vehicle cream	czqdnuagyt(mersnvniby) = swuigxftie moxyayhrme (unnbmkjgys ) View more
NCT04845620 (INTEGUMENT-PED, Company_Website) Manual	Phase 3	Moderate Atopic Dermatitis \| Dermatitis, Atopic	652	0.05% ZORYVEZORYVE	dardkzwafp(wjdctxxlfk) = vudodloqbw kkectzbjau (dskdqadlst ) View more	Positive	24 Feb 2025
				vehicle-controlled	dardkzwafp(wjdctxxlfk) = ehsgxogade kkectzbjau (dskdqadlst ) View more
NCT04773587 \| NCT04773600 (INTEGUMENT-1 \| INTEGUMENT-2, Pubmed \| JAMA Dermatol)	Phase 3	Skin injury	1,337	Roflumilast cream, 0.15%	bnzqtlmemx(drpxbcropr) = hlvjoejijn ekukldrvto (hpdogotioh )	Positive	01 Nov 2024
				Vehicle cream	bnzqtlmemx(drpxbcropr) = bwcaumckxc ekukldrvto (hpdogotioh )

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