TheraRadar
Data updated: May 26, 2026

ROFLUMILAST

Phosphodiesterase 4 Inhibitors
Respiratory Approved 2018-07-13

Roflumilast helps patients with severe COPD who also have chronic bronchitis and a history of frequent flare-ups. It is used to lower the risk of these COPD exacerbations over time. It is important to note that this medication does not work as a bronchodilator and should not be used to provide immediate relief for sudden breathing problems. Patients typically begin with a lower starting dose for the first four weeks before moving to a therapeutic dose.

Source: FDA Label • PRINSTON INC • Phosphodiesterase 4 Inhibitor
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How ROFLUMILAST Works

This medication works by selectively blocking phosphodiesterase 4 (PDE4), an enzyme in lung tissue that breaks down cyclic AMP. By inhibiting this enzyme, the drug and its active metabolite cause cyclic AMP to build up inside lung cells. This increase in intracellular cyclic AMP is believed to be the primary way the drug helps manage COPD symptoms.

Source: FDA Label
11
Indications
--
Phase 3 Trials
7
Years on Market

Details

Status
Prescription
First Approved
2018-07-13
PDUFA Date
2026-06-29 (34d)
Routes
ORAL
Dosage Forms
TABLET

Companies

PRINSTON INC ZYDUS PHARMS MICRO LABS MSN SENORES PHARMS STRIDES PHARMA HETERO LABS LTD III PHARMOBEDIENT TORRENT ALKEM LABS LTD Aurobindo Pharma
Active Ingredient: ROFLUMILAST

ROFLUMILAST Approval History

2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
31 FDA actions from 2018 to 2025
Jan 2025 SUPPL
Mfg · Manufacturing (CMC)
Jun 2023 SUPPL
Label · Labeling
Apr 2023 ORIGINAL
Update

What ROFLUMILAST Treats

2 indications

ROFLUMILAST is approved for 2 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Chronic Obstructive Pulmonary Disease
  • Chronic Bronchitis
Source: FDA Label

ROFLUMILAST Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

MoA expansion candidates

2

Same target(s), different indications — where else is this mechanism being explored?

OTEZLA XR
Amgen
2025 3 indic.
OTEZLA
Amgen
2014 4 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER
B BRAUN
2025 7 indic.
ZEVTERA
ISTX
2024 5 indic.
Unlock 8 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to ROFLUMILAST

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ARFORMOTEROL TARTRATE
ARFORMOTEROL TARTRATE
2 shared
AIPING PHARM INC
Shared indications:
Chronic Obstructive Pulmonary DiseaseChronic Bronchitis
ATROVENT HFA
IPRATROPIUM BROMIDE
2 shared
Boehringer Ingelheim
Shared indications:
Chronic Obstructive Pulmonary DiseaseChronic Bronchitis
BREYNA
BUDESONIDE
2 shared
Viatris
Shared indications:
Chronic Obstructive Pulmonary DiseaseChronic Bronchitis
View all 20 similar drugs Pro
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Clinical Trial Registry

46 trials
Trial Sponsor ID Phase Status Title
NCT07566351 MDP.26.03.216 Ph 2 recruiting Effect of Roflumilast and Desloratadine as Add-On Therapy in Patients With Rheumatoid Arthritis
NCT06860958 98421 Ph 3 recruiting Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients
NCT04069312 RELIANCE IRB00179281 Ph 4 completed Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE)
NCT04636814 PILLAR CLI-06001AA1-05 2020-003648-97, 2023-510174-13-00 Ph 3 terminated 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)
NCT07352566 25-43621 Ph 4 not yet recruiting Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
NCT05418049 2022-0202 U54HD104461 Ph 2 active not recruiting Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge
NCT07174011 AA MS-79-2025 Ph 4 completed Evaluation of the Efficacy and Safety of Oral Roflumilast Versus Intralesional Corticosteroids Injection (ILCs) in the Treatment of Alopecia Areata
NCT06977711 CTMS# 24-0122 STUDY00001006 Ph 1 recruiting Loncastuximab and Roflumilast Added to R-CHOP (Lo-(Rituximab and Roflumilast) RR-CHOP) for Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL)
NCT06457191 REB23-1506 Ph 1 active not recruiting Roflumilast and TMS Motor Plasticity
NCT06440473 Pro00078950 Ph 4 recruiting Visualization of Topical Zoryve vs. Vehicle Using Line Field Optical Coherence Tomography in Healthy Skin
NCT03458546 CTMS# 17-0087 18-073H Ph 1 completed Study of Roflumilast in Combination With Standard Chemotherapy for High-risk Diffuse Large B-cell Lymphoma
NCT05369793 35420/4/22 Ph 3 completed Clinical Study Evaluating the Safety and Efficacy of Roflumilast in Type 2 Diabetic Patients With Diabetic Neuropathy
NCT04108377 1406843 Ph 1 terminated Phosphodiesterase 4 Inhibitor, Roflumilast, and the Effects of Inhibition in Severe Asthma
NCT04549870 PSORRO H-20013697 Ph 2 completed Efficacy of Roflumilast in the Treatment of Psoriasis
NCT05684744 Kapu27 Ph 2, Ph 3 completed Roflumilast Versus Methotrexate in Psoriasis
NCT03764475 results posted ARQ-151-202 Ph 2 completed Long-Term Safety of ARQ-151 Cream in Adult Subjects With Chronic Plaque Psoriasis
NCT04800172 34538/3/21 Ph 3 completed The Possible Effects of Roflumilast on Obesity Related Disorders
NCT04744090 MS-292-2020 Ph 2 completed Roflumilast as add-on Therapy in Early Cases of ARDS
NCT04369547 REB20-0196 Ph 1 withdrawn Roflumilast TMS-EEG Plasticity
NCT01973998 results posted 21474 Ph 3 completed Effects of Roflumilast in Hospitalized Chronic Obstructive Pulmonary Disease( COPD) on Mortality and Re-hospitalization
NCT01433666 EEGrofl METC11-3-035 ZonMw (the Netherlands), 2011-002070-23 Ph 2 completed Roflumilast and Cognition
NCT01509677 results posted RO-2455-402-RD 2011-000582-13, U1111-1155-8767 Ph 3 completed Trial to Assess the Anti-inflammatory Effects of Roflumilast in Chronic Obstructive Pulmonary Disease
NCT04122547 25132558 Ph 3 completed Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis
NCT02671942 CTTQ-01459-IIA Ph 2 terminated A Multicenter Randomized Double-blind Clinical Study Evaluated the Safety, Pharmacokinetic and Pharmacodynamic Characteristics of Roflumilast in COPD Patients
NCT01630200 ELASTIC results posted ELASTIC2011 Ph 4 completed Effects of ROFLUMILAST on Subclinical Atherosclerosis in Chronic Obstructive Pulmonary Disease (COPD)
NCT01862029 results posted 130123 13-H-0123 Ph 1, Ph 2 completed Effects of Roflumilast on Insulin and Blood Sugar Levels in Prediabetic Overweight and Obese Individuals
NCT02340520 results posted 14-032-3 Ph 3 completed Enhancement of Corticosteroid Efficacy in COPD
NCT02451540 FLUI-2014-134 Ph 2 terminated Evaluation of the Effect of Roflumilast in Hyperinflated COPD Patients Using Functional Respiratory Imaging
NCT02097992 results posted 20120591 DAL-IT-06 Ph 1, Ph 2 completed Effect of Roflumilast on Airway Blood Flow as an Expression of Airway Inflammation in COPD
NCT01745848 results posted PRO12060615 Ph 4 completed Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD
NCT03073798 results posted NA_00078710 Ph 4 completed The Effectiveness of Roflumilast in Improving Mucociliary Clearance in Patients With COPD and Chronic Bronchitis
NCT02165826 OPTIMIZE results posted RO-2455-302-RD U1111-1150-2477, 2013-001788-21 Ph 3 completed Evaluation of Tolerability and Pharmacokinetics of Roflumilast, 250μg and 500μg, as add-on to Standard COPD Treatment to Treat Severe COPD
NCT01443845 results posted ROF-MD-07 Ph 4 completed Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)
NCT01730404 CCD-1201-PR-0079 Ph 2 completed Safety, Tolerability and Efficacy of 28-day Inhaled CHF 6001 DPI in COPD Patients
NCT01473758 TREAT results posted RO-2455-405-RD 2011-002905-31, U1111-1137-4023 Ph 2 terminated Effect of Roflumilast at Acute Exacerbations of Chronic Obstructive Pulmonary Disease
NCT01703260 results posted ROF-NASH_205 U1111-1129-5051 Ph 2 terminated Safety and Efficacy of Roflumilast and Pioglitazone in Treating Adults With Nonalcoholic SteatoHepatitis
NCT01313494 ACROSS results posted RO-2455-301-RD U1111-1133-6304 Ph 3 completed A Chronic Obstructive Pulmonary Disease (COPD) Trial Investigating Roflumilast on Safety and Effectiveness in China, Hong Kong and Singapore:
NCT01765192 results posted ROF-ASTHMA_202 U1111-1132-3160, 2012-002064-27 Ph 2 completed Roflumilast Plus Montelukast in Adults With Severe Asthma
NCT02051335 results posted ROF-ALZ_102 2012-002089-11, U1111-1151-7178 Ph 1 completed Roflumilast and Donepezil to Reverse Scopolamine Induced Cognitive Deficits in Healthy Adults
NCT01664624 results posted ROF-T2D_107 U1111-1128-6945 Ph 1 completed Roflumilast Plus Alogliptin Proof-of-Mechanism Study in Type2 Diabetes
NCT01329029 REACT results posted RO-2455-404-RD 2010-019685-87, U1111-1141-7422 Ph 4 completed Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Combinations of Long-acting β2-agonists (LABA) and Inhaled Glucocorticosteroid (ICS)
NCT01354782 RO-2455-101-EC Ph 1 completed Pharmacokinetic Study of Single and Repeated Dose of Roflumilast 500 µg , in Healthy Chinese Subjects
NCT02079844 results posted ROF-SCHZ_106 2012-002091-13, U1111-1152-3899 Ph 1 completed Roflumilast Plus Antipsychotics Proof of Mechanism Study in Schizophrenia
NCT01701934 RAMBO RAMBO Ph 2 terminated Impact of Roflumilast on Visceral Adiposity and Metabolic Profile in Chronic Obstructive Pulmonary Disease
NCT02187250 DAXAS 2 Ph 4 completed PDE-4 Inhibitor Roflumilast and GLP-1 Agonist Liraglutide in Polycystic Ovary Syndrome
NCT01480661 FLUI-2011-77 2011-004271-36 Ph 4 completed Evaluation With CT Scan of Possible Changes in Airways After Treatment With Daxas® in Severe Chronic Obstructive Pulmonary Disease Patients
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ROFLUMILAST FDA Label Details

Indications & Usage

ROFLUMILAST is indicated for the treatment of Chronic Obstructive Pulmonary Disease; Chronic Bronchitis.

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Data Sources

FDA Approval: ANDA208299 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.