Roflumilast

Phase 2/3Completed

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Interest: 38/100

Hype Score

Development Stage

✓

Pre-clinical

✓

Phase 1

Phase 2

Phase 3

Approved

Indication / Disease

Bronchial Asthma

Conditions

Bronchial Asthma

Trial Timeline

May 1, 2004 → Jun 1, 2007

NCT ID

NCT00242307

About Roflumilast

Roflumilast is a phase 2/3 stage product being developed by AstraZeneca for Bronchial Asthma. The current trial status is completed. This product is registered under clinical trial identifier NCT00242307. Target conditions include Bronchial Asthma.

What happened to similar drugs?

3 of 16 similar drugs in Bronchial Asthma were approved

Approved (3) Terminated (3) Active (10)

✅MontelukastMerckApproved

✅Formoterol fumerate + fenoterol/ipratropium bromideNovartisApproved

✅Montelukast chewable tablets + Budesonide inhaler + Placebo to montelukast chewable tablets + Placebo to budesonide inhalerOrganonApproved

🔄Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation) + Ventolin HFA 90Mcg/Actuation Inhalation Aerosol_#1 + Ventolin HFA, 90 Mcg/Inh Inhalation Aerosol_#2 + PlaceboCiplaPhase 3

🔄90 mcg Reference Product + 180 mcg Reference Product + 90 mcg Test Product + PlaceboCiplaPhase 3

🔄Fluticasone propionate/salmeterol 100/50 µg + Advair Diskus 100/50 Dry Powder Inhaler, 60 ACTUATCiplaPhase 3

🔄Test Product + Reference Product + PlaceboAurobindo PharmaPhase 3

Hype Score Breakdown

Clinical

Activity

Company

Novelty

Community

Clinical Trials (16)

NCT ID	Phase	Status	Start	Completion	Indication
NCT03381573	Pre-clinical	Completed	Dec 15, 2013	Sep 16, 2022	COPD
NCT02068456	Pre-clinical	Completed	Sep 18, 2012	Apr 26, 2017	Chronic Obstructive Pulmonary Disease
NCT01354782	Phase 1	Completed	May 1, 2011	Sep 1, 2011	Chronic Obstructive Pulmonary Disease
NCT01140542	Phase 2	Completed	Aug 1, 2006	Mar 1, 2008	Diabetes Mellitus Type 2
NCT00246935	Phase 3	Completed	May 1, 2005	Oct 1, 2007	Chronic Obstructive Pulmonary Disease (COPD)
NCT00246922	Phase 3	Completed	Dec 1, 2004	Oct 1, 2007	Bronchial Asthma
NCT00242294	Phase 2/3	Completed	Nov 1, 2004	Mar 1, 2007	Chronic Obstructive Pulmonary Disease (COPD)
NCT00108823	Phase 3	Completed	Oct 1, 2004	—	Chronic Obstructive Pulmonary Disease, COPD
NCT00242307	Phase 2/3	Completed	May 1, 2004	Jun 1, 2007	Bronchial Asthma
NCT00163475	Phase 3	Completed	May 1, 2004	Aug 1, 2005	Asthma
NCT00076076	Phase 3	Completed	Dec 1, 2003	Jun 1, 2005	Asthma
NCT00076089	Phase 3	Completed	Dec 1, 2003	Dec 1, 2005	Chronic Obstructive Pulmonary Disease
NCT00073177	Phase 3	Completed	Nov 1, 2003	—	Asthma
NCT00062582	Phase 3	Completed	Jun 1, 2003	—	Chronic Obstructive Pulmonary Disease
NCT00163527	Phase 3	Completed	Apr 1, 2003	Nov 1, 2005	Asthma
NCT00430729	Phase 3	Completed	Jan 1, 2003	—	Chronic Obstructive Pulmonary Disease

Competing Products

20 competing products in Bronchial Asthma

See all competitors

Product	Company	Stage	Hype Score
Tacrolimus	Astellas Pharma	Phase 2	35
tacrolimus	Astellas Pharma	Phase 2	35
Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation) + Ventolin HFA 90Mcg/Actuation Inhalation Aerosol_#1 + Ventolin HFA, 90 Mcg/Inh Inhalation Aerosol_#2 + Placebo	Cipla	Phase 3	40
90 mcg Reference Product + 180 mcg Reference Product + 90 mcg Test Product + Placebo	Cipla	Phase 3	40
Fluticasone propionate/salmeterol 100/50 µg + Advair Diskus 100/50 Dry Powder Inhaler, 60 ACTUAT	Cipla	Phase 3	40
Test Product + Reference Product + Placebo	Aurobindo Pharma	Phase 3	40
Albuterol Sulfate HFA 0.09 mg (Reference) + Albuterol Sulfate HFA 0.18 mg (Reference) + Albuterol Sulfate HFA 0.09 mg (Test) + Albuterol Sulfate HFA 0.18 mg (Test) + Placebo	Aurobindo Pharma	Phase 3	32
Fluticasone propionate Inhalation Aerosol 44 mcg + FLOVENT HFA 44 mcg + Matching Placebo inhaler	Glenmark Pharmaceuticals	Phase 3	36
Symbicort Turbuhaler + Symbicort pMDI + Pulmicort Turbuhaler	AstraZeneca	Phase 3	40
Roflumilast	AstraZeneca	Phase 3	40
Symbicort (budesonide/formoterol) Turbuhaler + Conventional treatment	AstraZeneca	Phase 3	32
Ciclesonide	AstraZeneca	Phase 3	40
Montelukast plus prednisolone + Prednisolone	Merck	Phase 2	35
Montelukast	Merck	Approved	43
Formoterol fumerate + fenoterol/ipratropium bromide	Novartis	Approved	43
inhaled corticosteroid therapy	Novartis	Phase 1/2	32
PF-00610355 + PF - 00610355 + PF - 00610355	Pfizer	Phase 2	27
Nivolumab	Bristol Myers Squibb	Phase 2	39
HSK31858 + Placebo	Haisco Pharmaceutical Group	Phase 2	42
HSK31858 + Placebo	Haisco Pharmaceutical Group	Phase 2	42