Daliresp

(Roflumilast)

ApprovedSmall molecule

Roflumilast is used to treat chronic obstructive pulmonary disease (COPD) by reducing inflammation in the airways and helping to prevent flare-ups and breathing problems.[2] Daliresp is currently approved and in use across 24 indications[4].[1]

Daliresp is one of 523 small molecule programs targeting Other Conditions of Brain. It is currently in Approved.

Indications

Total Trials

Active Trials

522

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Other Conditions of BrainActive, not recruiting

Airway ObstructionActive, not recruiting

Hidradenitis SuppurativaApproved

DermatitisApproved

Type 2 Diabetes MellitusApproved

Chronic BronchitisActive, not recruiting

Fragile X SyndromeApproved

Seborrheic DermatitisApproved

Brain DiseaseApproved

Adult Acute Respiratory Distress SyndromeApproved

Other Conditions of BrainPhase 1

Active, not recruiting

Airway ObstructionApproved

Active, not recruiting

Hidradenitis SuppurativaApproved

Approved

DermatitisApproved

Approved

Type 2 Diabetes MellitusApproved

Approved

Chronic BronchitisApproved

Active, not recruiting

Fragile X SyndromeApproved

Approved

Seborrheic DermatitisApproved

Approved

Brain DiseaseApproved

Approved

Adult Acute Respiratory Distress SyndromeApproved

Approved

Showing 10 of 24 indications

Competition

Competitive Landscape

401 competitors in Lymphoma

#DrugCompanyPhaseTrials

Daliresp

AstraZeneca

Approved

94 2

Zofran

Novartis

Preclinical

2 3

Cabenuva

GSK

Preclinical

1 4

Norvir

AbbVie

Preclinical

1 5

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 6

Kenalog

BBausch Health Americas, Inc.

Preclinical

1 7

Nuvigil

NNuvo Research GmbH

Preclinical

1 8

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

—9

Decadron

QQuince Therapeutics S.p.A.

Preclinical

—10

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

ApprovedNot yet recruiting

COPD

NCT07795086

Q2 2027

Phase 1Recruiting

Diffuse Large B-Cell Lymphoma

NCT06977711

Q4 2027

Phase 2Not yet recruiting

Moderate to Severe COPD

NCT07314242

Q4 2028

Phase 1Recruiting

Adjuvant

NCT06643221

Clinical

Trials by Indication[1]

Chronic Obstructive Pulmonary Disease21 trials

Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT01443845·2,354 enrolled

Effect of Roflumilast on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BY217/M2-110)

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00062582·1,000 enrolled

OPUS Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (BY217/M2-111)

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00076089·1,100 enrolled

Show 18 more trials

Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-08)

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00246935·150 enrolled

Effect of Roflumilast at Acute Exacerbations of Chronic Obstructive Pulmonary Disease

Terminated· AstraZeneca logo

AstraZeneca·Phase 2·NCT01473758·81 enrolled

Evaluation With CT Scan of Possible Changes in Airways After Treatment With Daxas® in Severe Chronic Obstructive Pulmonary Disease Patients

Completed·FFLUIDDA nv·Phase 4·NCT01480661·41 enrolled

A Placebo-controlled Trial of Daliresp on Chronic Obstructive Pulmonary Disease (COPD)

Completed·UUniversity of Alabama at Birmingham·N/A·NCT01572948·27 enrolled

Effect of Roflumilast on Lung Function in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Salmeterol: The EOS Study (BY217/M2-127)

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00313209·933 enrolled

Effect of Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Tiotropium: The HELIOS Study (BY217/M2-128)

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00424268·743 enrolled

Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. Ratio-Study. (BY217/M2-112)

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00430729·1,100 enrolled

The HERO-study: Effects of Roflumilast in Patients With COPD (Chronic Obstructive Pulmonary Disease) (BY217/M2-121)

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00108823·550 enrolled

Effects of Roflumilast in Hospitalized Chronic Obstructive Pulmonary Disease( COPD) on Mortality and Re-hospitalization

Completed·TTemple University·Phase 3·NCT01973998·68 enrolled

Efficacy and Safety of Oral Roflumilast Taken Once Daily in Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (BY217/M2-119)

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00242320·551 enrolled

Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Combinations of Long-acting β2-agonists (LABA) and Inhaled Glucocorticosteroid (ICS)

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT01329029·1,945 enrolled

Impact of Roflumilast on Visceral Adiposity and Metabolic Profile in Chronic Obstructive Pulmonary Disease

Terminated·LLaval University·Phase 2·NCT01701934·14 enrolled

Trial to Assess the Anti-inflammatory Effects of Roflumilast in Chronic Obstructive Pulmonary Disease

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT01509677·158 enrolled

Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The HERMES Study (BY217/M2-125)

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00297115·1,568 enrolled

A Chronic Obstructive Pulmonary Disease (COPD) Trial Investigating Roflumilast on Safety and Effectiveness in China, Hong Kong and Singapore:

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT01313494·626 enrolled

Effects of ROFLUMILAST on Subclinical Atherosclerosis in Chronic Obstructive Pulmonary Disease (COPD)

Completed·LLudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology·Phase 4·NCT01630200·80 enrolled

Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00297102·1,523 enrolled

Efficacy and Safety of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-06)

Completed· AstraZeneca logo

AstraZeneca·Phase 2/3·NCT00242294·570 enrolled

Asthma9 trials

Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012)

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00073177·819 enrolled

Efficacy and Safety of Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Asthma (12 to 70 y) (BY217/M2-013)

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00163527·2,054 enrolled

Efficacy and Safety of Roflumilast Taken in the Morning or Evening in Patients With Stable Asthma (12 to 70 y) (BY217/M2-015)

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00163475·511 enrolled

Show 6 more trials

Phosphodiesterase 4 Inhibitor, Roflumilast, and the Effects of Inhibition in Severe Asthma

Terminated·UUniversity of California, Davis·Phase 1·NCT04108377·5 enrolled

Roflumilast Plus Montelukast in Adults With Severe Asthma

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT01765192·64 enrolled

Efficacy and Safety of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 70 y) (APTA-2217-05)

Completed· AstraZeneca logo

AstraZeneca·Phase 2/3·NCT00242307·450 enrolled

Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 71 y) (APTA-2217-07)

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00246922·150 enrolled

Trial of Roflumilast in Asthma Management (TRIM)

Completed·JJohns Hopkins University·Phase 2·NCT03532490·38 enrolled

The FLASH Study: A Study of Roflumilast Versus Placebo in Patients With Asthma (BY217/M2-023)

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00076076·822 enrolled

Psoriasis5 trials

Efficacy of Roflumilast in the Treatment of Psoriasis

Completed·—·Phase 2·NCT04549870·46 enrolled

Long-Term Safety of ARQ-151 Cream in Adult Subjects With Chronic Plaque Psoriasis

Completed·AArcutis Biotherapeutics, Inc.·Phase 2·NCT03764475·332 enrolled

A Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild to Moderate Plaque Psoriasis

Withdrawn· AstraZeneca logo

AstraZeneca·Phase 2·NCT00746434

Show 2 more trials

A Pilot Study to Assess How Safe and Effective Oral Roflumilast is for Treating Moderate to Severe Psoriasis in Adults

Recruiting·AAhmed Ibrahim·Phase 2·NCT07233291·36 enrolled

Roflumilast Versus Methotrexate in Psoriasis

Completed·—·Phase 2/3·NCT05684744·30 enrolled

Bronchiectasis4 trials

Phase2, Single Group, Open Clinical Trial to Evaluate the Efficacy and Safety of Roflumilast in Symptomatic Bronchiectasis Patients

Unknown status·SSeoul National University Bundang Hospital·Phase 2·NCT01580748·25 enrolled

Roflumilast in Non-CF Bronchiectasis Study (2019)

Completed·TThe University of Hong Kong·Phase 2·NCT04322929·42 enrolled

Roflumilast in Non-CF Bronchiectasis Study

Completed·TThe University of Hong Kong·Phase 2·NCT03428334·20 enrolled

Show 1 more trial

Effect of Roflumilast on Quality of Life, Lung Function and Mucus Properties in Patients With Bronchiectasis

Unknown status·UUniversity of Sao Paulo General Hospital·Phase 2·NCT03988816·30 enrolled

Atopic Dermatitis4 trials

A Placebo Controlled 4 Week Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild Atopic Dermatitis (RO-2351-001-EM)

Withdrawn· AstraZeneca logo

AstraZeneca·Phase 2·NCT00746382

Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II)

Completed·AArcutis Biotherapeutics, Inc.·Phase 3·NCT04773600·683 enrolled

Evaluation of Efficacy and Safety of Oral Roflumilast for Treatment of Moderate to Severe Atopic Dermatitis in Patients Aged 12 Years and Older: A Pilot Study

Recruiting·NNora Mohamed Abdelrazik·Phase 2·NCT07297602·36 enrolled

Show 1 more trial

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

Not yet recruiting·UUniversity of California, San Francisco·Phase 4·NCT07352566·10 enrolled

45 more indications

Efficacy2 trials

Enhancement of Corticosteroid Efficacy in COPD

Completed·UUConn Health·Phase 3·NCT02340520·13 enrolled

Safety, Tolerability and Efficacy of 28-day Inhaled CHF 6001 DPI in COPD Patients

Completed· Chiesi Farmaceutici S.p.A. logo

Chiesi Farmaceutici S.p.A.·Phase 2·NCT01730404·55 enrolled

Cystic Fibrosis2 trials

Assessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis Bronchiectasis

Unknown status·—·Phase 1·NCT04090294·35 enrolled

Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis

Completed·PPrince of Songkla University·Phase 3·NCT04122547·40 enrolled

Chronic Bronchitis2 trials

A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PILLAR)

Terminated· Chiesi Farmaceutici S.p.A. logo

Chiesi Farmaceutici S.p.A.·Phase 3·NCT04636814·3,973 enrolled

The Effectiveness of Roflumilast in Improving Mucociliary Clearance in Patients With COPD and Chronic Bronchitis

Completed·JJohns Hopkins University·Phase 4·NCT03073798·12 enrolled

Diffuse Large B-Cell Lymphoma2 trials

Study of Roflumilast in Combination With Standard Chemotherapy for High-risk Diffuse Large B-cell Lymphoma

Completed·TThe University of Texas Health Science Center at San Antonio·Phase 1·NCT03458546·14 enrolled

Phase Ib Clinical Trial of Loncastuximab and Roflumilast Added to R-CHOP (Lo-RR-CHOP) for Treatment Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL)

Recruiting·TThe University of Texas Health Science Center at San Antonio·Phase 1·NCT06977711·10 enrolled

COPD2 trials

Comparative Effectiveness of Roflumilast and Azithromycin in Reducing Exacerbations in Severe Chronic Obstructive Pulmonary Disease ( COPD ) Patients With Chronic Bronchitis Phenotype

Not yet recruiting·SSidra Aziz·Approved·NCT07795086·70 enrolled

Roflumilast or Azithromycin to Prevent COPD Exacerbations Trial

Completed·JJohns Hopkins University·Phase 3·NCT04069312·1,032 enrolled

Rosacea1 trial

Evaluation of the Safety and Efficacy of Topical Roflumilast Cream in the Treatment of Facial Papulopustular Rosacea

Completed·DDermatology Consulting Services, PLLC·Phase 2·NCT05278624·40 enrolled

Cognitive Deficit1 trial

Roflumilast and Donepezil to Reverse Scopolamine Induced Cognitive Deficits in Healthy Adults

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02051335·27 enrolled

Efficacy and Safety1 trial

Evaluating the Efficacy and Safety of Roflumilast in Patients with NASH

Completed·TTanta University·Phase 2·NCT06677788·55 enrolled

Moderate to Severe COPD1 trial

A Study to Investigate the Biomarkers of Hemay005 in Adult Participants With Moderate to Severe COPD

Not yet recruiting·GGanzhou Hemay Pharmaceutical Co., Ltd·Phase 2·NCT07314242·120 enrolled

Diabetic Neuropathy1 trial

Clinical Study Evaluating the Safety and Efficacy of Roflumilast in Type 2 Diabetic Patients With Diabetic Neuropathy

Completed·TTanta University·Phase 3·NCT05369793·60 enrolled

Hepatitis1 trial

Safety and Efficacy of Roflumilast and Pioglitazone in Treating Adults With Nonalcoholic SteatoHepatitis

Terminated· AstraZeneca logo

AstraZeneca·Phase 2·NCT01703260·20 enrolled

Single Dose1 trial

Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge

Active, not recruiting·—·Phase 2·NCT05418049·45 enrolled

EEG1 trial

Roflumilast TMS-EEG Plasticity

Withdrawn·UUniversity of Calgary·Phase 1·NCT04369547

Treatment1 trial

Evaluation of Tolerability and Pharmacokinetics of Roflumilast, 250μg and 500μg, as add-on to Standard COPD Treatment to Treat Severe COPD

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT02165826·1,323 enrolled

Allergic Asthma1 trial

A Study to Evaluate the Effect of Roflumilast on Airway Inflammation and Function Following Allergen Challenge in Subjects With Allergic Asthma

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT01365533·48 enrolled

Type 2 Diabetes1 trial

Roflumilast Plus Alogliptin Proof-of-Mechanism Study in Type2 Diabetes

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01664624·40 enrolled

ARDS1 trial

Roflumilast as add-on Therapy in Early Cases of ARDS

Completed·—·Phase 2·NCT04744090·76 enrolled

Hematologic Malignancies1 trial

Phase 0/1 Biomarker and Pharmacodynamic Study of Roflumilast in Patients With Advanced B-Cell Hematologic Malignancies (CTRC# 13-0013)

Completed·—·Phase 1·NCT01888952·10 enrolled

Inflammation1 trial

Effect of Roflumilast on Airway Blood Flow as an Expression of Airway Inflammation in COPD

Completed·UUniversity of Miami·Phase 1/2·NCT02097992·11 enrolled

Diabetes Mellitus1 trial

Efficacy of 500µg Roflumilast Once Daily Versus Placebo Over 12 Weeks in Patients With Diabetes Mellitus Type 2. A Double Blind, Parallel Group, Proof of Concept Clinical Study

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT01140542·487 enrolled

Endothelial Function1 trial

Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD

Completed·UUniversity of Pittsburgh·Phase 4·NCT01745848·26 enrolled

Optical Coherence Tomography1 trial

Visualization of Topical Zoryve vs. Vehicle Using Line Field Optical Coherence Tomography in Healthy Skin

Recruiting·RRao Dermatology·Phase 4·NCT06440473·3 enrolled

Stroke1 trial

Roflumilast to Treat Cognitive Sequela After Stroke

Completed·MMaastricht University·Phase 2·NCT04854811·100 enrolled

Ulcerative Colitis1 trial

Role of Roflumilast in Ulcerative Colitis

Completed·TTanta University·Phase 4·NCT05684484·52 enrolled

Adjuvant1 trial

Exercise as an Immune Adjuvant for Allogeneic Cell Therapies

Recruiting·UUniversity of Arizona·Phase 1·NCT06643221·100 enrolled

Polycystic Ovary Syndrome1 trial

PDE-4 Inhibitor Roflumilast and GLP-1 Agonist Liraglutide in Polycystic Ovary Syndrome

Completed·UUniversity Medical Centre Ljubljana·Phase 4·NCT02187250·45 enrolled

Cognition1 trial

Roflumilast and Cognition

Completed·MMaastricht University Medical Center·Phase 2·NCT01433666·22 enrolled

Major Depressive Disorder1 trial

Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients

Recruiting·TTanta University·Phase 3·NCT06860958·60 enrolled

Sarcoidosis1 trial

Use of Roflumilast to Prevent Exacerbations in Fibrotic Sarcoidosis Patients (REFS)

Unknown status·UUniversity of Cincinnati·Phase 4·NCT01830959·50 enrolled

TED1 trial

Pharmacokinetic Study of Single and Repeated Dose of Roflumilast 500 µg , in Healthy Chinese Subjects

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01354782·32 enrolled

Dementia1 trial

Cognitive Effects of Roflumilast in (a)MCI and Mild Dementia Patients

Unknown status·MMaastricht University Medical Center·Phase 2·NCT04658654·81 enrolled

Obesity1 trial

The Possible Effects of Roflumilast on Obesity Related Disorders

Completed·TTanta University·Phase 3·NCT04800172·66 enrolled

Diabetic Nephropathy1 trial

Possible Role of Roflumilast in Diabetic Nephropathy

Unknown status·TTanta University·Phase 3·NCT04755946·48 enrolled

Alopecia Areata1 trial

Evaluation of the Efficacy and Safety of Oral Roflumilast Versus Intralesional Corticosteroids Injection (ILCs) in the Treatment of Alopecia Areata

Completed·—·Phase 4·NCT07174011·50 enrolled

Double-blind1 trial

A Multicenter Randomized Double-blind Clinical Study Evaluated the Safety, Pharmacokinetic and Pharmacodynamic Characteristics of Roflumilast in COPD Patients

Terminated· Chia Tai Tianqing Pharmaceutical Group Co., Ltd. logo

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Phase 2·NCT02671942·55 enrolled

Diagnosis1 trial

Pre-Clinical (Alzheimers) Diagnosis PCD = Optimum Outcomes OO

Unknown status· Takeda logo

Takeda··NCT02835716·150 enrolled

Peripheral Neuropathy1 trial

Efficacy of Roflumilast in Prevention of Peripheral Neuropathy

Unknown status·MMansoura University·Phase 1/2·NCT05884281·60 enrolled

Schizophrenia1 trial

Roflumilast Plus Antipsychotics Proof of Mechanism Study in Schizophrenia

Completed· Takeda logo

Takeda·Phase 1·NCT02079844·20 enrolled

Observational Study1 trial

Long-term Observational Study of the Safety of Roflumilast

Completed· AstraZeneca logo

AstraZeneca··NCT03381573·135,856 enrolled

Overweight1 trial

Effects of Roflumilast on Insulin and Blood Sugar Levels in Prediabetic Overweight and Obese Individuals

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 1/2·NCT01862029·24 enrolled

Function1 trial

Evaluation of the Effect of Roflumilast in Hyperinflated COPD Patients Using Functional Respiratory Imaging

Terminated·FFLUIDDA nv·Phase 2·NCT02451540·13 enrolled

Interaction1 trial

Pharmacodynamic/Pharmacokinetic Interactions Between Oral Roflumilast and Inhaled Formoterol

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT00940329·27 enrolled

Chronic Plaque Psoriasis1 trial

A Phase 3, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.3% in Subjects With Chronic Plaque Psoriasis

Completed·AArcutis Biotherapeutics, Inc.·Phase 3·NCT04286607·337 enrolled

Chronic Hand Eczema1 trial

Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO) - a Randomized Controlled Trial

Completed·JJacob Pontoppidan Thyssen·Approved·NCT05682859·41 enrolled

Unspecified2 trials

Roflumilast and TMS Motor Plasticity

Active, not recruiting·UUniversity of Calgary·Phase 1·NCT06457191·20 enrolled

Post Marketing Surveillance of Roflumilast in Korea

Completed· AstraZeneca logo

AstraZeneca··NCT02068456·1,837 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 23, 2018

DALIRESP

NDA NDA022522

Dec 15, 2023

ZORYVE

NDA NDA217242

Jul 9, 2024

ZORYVE

NDA NDA215985

Sources

References

[1]
ClinicalTrials.gov — 94 trial records for Roflumilast. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Daliresp drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Roflumilast compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Roflumilast. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA215985). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Daliresp. U.S. Food & Drug Administration.
[7]
SEC EDGAR — AstraZeneca company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Phosphodiesterase 4 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AstraZeneca

Patent Landscape[6]

Patent Cliff

Jun 7, 2037

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12390453Jun 7, 2037

9907788Jun 7, 2037

12310956Jun 7, 2037

12005051Jun 7, 2037

11992480Jun 7, 2037

15 more patents

11819496Jun 7, 2037

12005052Jun 7, 2037

9884050Jun 7, 2037

12336983Jun 7, 2037

11793796Jun 7, 2037

10940142Jun 7, 2037

12257242Jun 7, 2037

12220409Jun 7, 2037

12011437Jun 7, 2037

12042487Jun 7, 2037

12016848Jun 7, 2037

11129818Aug 25, 2037

12329751Dec 3, 2041

11707454Dec 3, 2041

12453721Aug 19, 2042

Daliresp

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q4 2027

Q4 2028

Trials by Indication[1]

Chronic Obstructive Pulmonary Disease21 trials

Asthma9 trials

Psoriasis5 trials

Bronchiectasis4 trials

Atopic Dermatitis4 trials

Efficacy2 trials

Cystic Fibrosis2 trials

Chronic Bronchitis2 trials

Diffuse Large B-Cell Lymphoma2 trials

COPD2 trials

Rosacea1 trial

Cognitive Deficit1 trial

Efficacy and Safety1 trial

Moderate to Severe COPD1 trial

Diabetic Neuropathy1 trial

Hepatitis1 trial

Single Dose1 trial

EEG1 trial

Treatment1 trial

Allergic Asthma1 trial

Type 2 Diabetes1 trial

ARDS1 trial

Hematologic Malignancies1 trial

Inflammation1 trial

Diabetes Mellitus1 trial

Endothelial Function1 trial

Optical Coherence Tomography1 trial

Stroke1 trial

Ulcerative Colitis1 trial

Adjuvant1 trial

Polycystic Ovary Syndrome1 trial

Cognition1 trial

Major Depressive Disorder1 trial

Sarcoidosis1 trial

TED1 trial

Dementia1 trial

Obesity1 trial

Diabetic Nephropathy1 trial

Alopecia Areata1 trial

Double-blind1 trial

Diagnosis1 trial

Peripheral Neuropathy1 trial

Schizophrenia1 trial

Observational Study1 trial

Overweight1 trial

Function1 trial

Interaction1 trial

Chronic Plaque Psoriasis1 trial

Chronic Hand Eczema1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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