Drugs / Mometasone
Mometasone
also known as
mometasone furoate · MFNS · LAS 41002 · Mometasone Furoate monohydrate · Mometasone Twisthaler
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Atectura Breezhaler | — | 2020-05-30 | europa.eu ↗ |
Trials 32
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT03979209 | Jan 2019 → Jun 2021 | chronic rhinosinusitis | Rush University Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT02154334 | Jun → Oct 2014 | allergic rhinitis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01061333 | Jun 2010 → Feb 2011 | asthma | Merck Sharp & Dohme LLC | Completed | Mixed |
| Phase 28 trials · 5 met primary | ||||||
| Phase 2 | NCT05756647 | Nov 2022 → Jul 2023 | — | Washington University School of Medicine | Completed | Met primary |
| Phase 2 | NCT03444506 | Jan → Feb 2014 | seasonal allergic rhinitis | Glenmark Pharmaceuticals Ltd. India | Completed | Met primary |
| Phase 2 | NCT01636076 | Nov 2012 → Sep 2013 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01258803 | Dec 2010 → Oct 2011 | asthma | Organon and Co | Completed | Met primary |
| Phase 2 | NCT01119313 | Feb → Mar 2010 | atopic eczema | Almirall, S.A. | Completed | No outcome recorded |
| Phase 2 | NCT00605306 | Jan → Apr 2008 | asthma | Novartis | Completed | No outcome recorded |
| Phase 2 | NCT00557440 | Nov 2007 → Apr 2008 | asthma | Novartis | Completed | Met primary |
| Phase 2 | NCT00556673 | Oct 2007 → Apr 2008 | asthma | Novartis | Completed | Met primary |
| Phase 312 trials · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT05562466 | May 2023 → Feb 2028 expected | asthma | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT05311475 | Apr 2022 → Jun 2023 | seasonal allergic rhinitis | Sandoz | Completed | No outcome recorded |
| Phase 3 | NCT04206761 | Dec 2021 → Jul 2022 | asthma | Dr. Grace Parraga | Withdrawn | No outcome recorded |
| Phase 3 | NCT02953379 | May → Dec 2019 | allergic rhinitis | EMS | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT02953366 | May → Dec 2019 | allergic rhinitis | EMS | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT03463031 | Mar → Nov 2018 | seasonal allergic rhinitis | Glenmark Specialty S.A. | Completed | Met primary |
| Phase 3 | NCT03449836 | Mar → Sep 2018 | allergic disease | Federico II University | Completed | No outcome recorded |
| Phase 3 | NCT03158311 | Feb 2018 → Jul 2019 | asthma | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02709538 | Apr 2016 → Jul 2017 | perennial allergic rhinitis | Glenmark Specialty S.A. | Completed | No outcome recorded |
| Phase 3 | NCT02066298 | Jul 2014 → May 2018 | asthma | Milton S. Hershey Medical Center | Completed | Missed primary |
| Phase 3 | NCT01287364 | Feb → Apr 2011 | perennial allergic rhinitis | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01229085 | Sep 2006 → Oct 2007 | psoriasis | Azidus Brasil | Completed | No outcome recorded |
| Phase 47 trials · 1 missed | ||||||
| Phase 4 | NCT03590912 | Sep 2018 → Feb 2020 | otitis media with effusion | Lumbini Medical College | Completed | No outcome recorded |
| Phase 4 | NCT03605537 | Jul 2018 → Oct 2019 | choanal atresia | Children's Hospital Medical Center, Cincinnati | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT03011632 | Jan 2017 → Aug 2019 | asthma, chronic rhinosinusitis | Medical University of Lodz | Completed | No outcome recorded |
| Phase 4 | NCT00461812 | Apr 2007 → Jan 2010 | asthma | Johns Hopkins University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00783237 | Dec 2003 → Feb 2004 | allergic rhinitis | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT00070707 | Apr → Nov 2003 | asthma, seasonal allergic rhinitis | Organon and Co | Completed | Missed primary |
| Phase 4 | NCT00763529 | Jan 2003 → Jan 2005 | psoriasis | Organon and Co | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT02415179 | May 2015 → Feb 2016 | asthma | Mahidol University | Completed | No outcome recorded |
| — | NCT01210170 | Oct 2010 → Feb 2013 | asthma | University of Miami | Completed | No outcome recorded |
| Comparator or background therapy23 trials | ||||||
| Phase 1 | NCT04615962 Comparator | Jan 2021 → Jan 2022 | atopic eczema | Seanergy Dermatology Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT01371786 Comparator | Jun → Aug 2011 | allergic rhinitis | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00721331 Comparator | Jul → Sep 2008 | atopic eczema | Zalicus | Completed | No outcome recorded |
| Phase 2 | NCT03758950 Comparator | Nov 2018 → May 2023 | sickle cell disease | Jeffrey Glassberg | Completed | No outcome recorded |
| Phase 2 | NCT02318303 Comparator | Dec 2014 → Feb 2015 | seasonal allergic rhinitis | Glenmark Pharmaceuticals Ltd. India | Completed | No outcome recorded |
| Phase 2 | NCT00941798 Comparator | Jul 2009 → May 2011 | asthma | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 2 | NCT00666679 Comparator | May 2008 → Feb 2009 | asthma | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT05590598 Background | Feb → Jun 2023 | seasonal allergic rhinitis | Sandoz | Completed | No outcome recorded |
| Phase 3 | NCT04259164 Background | Sep 2020 → Dec 2022 | allergic asthma | University Medical Center Groningen | Completed | No outcome recorded |
| Phase 3 | NCT03323866 Comparator | May 2017 → May 2022 | chronic rhinosinusitis | University of Sherbrooke | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT02541760 Comparator | Apr 2014 → Mar 2015 | otitis media with effusion | Hormozgan University of Medical Sciences | Completed | No outcome recorded |
| Phase 3 | NCT01850823 Comparator | Feb → Dec 2013 | seasonal allergic rhinitis | Actavis Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01566149 Comparator | Mar → Sep 2012 | asthma | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT01401465 Comparator | Jul → Nov 2011 | perennial allergic rhinitis | Sumitomo Pharma America, Inc. | Completed | Met primary |
| Phase 3 | NCT00562159 Background | Nov 2007 → Sep 2009 | allergic disease, conjunctivitis, rhinitis | ALK-Abelló A/S | Completed | Met primary |
| Phase 4 | NCT07052942 Comparator | Aug 2025 → Nov 2029 expected | acute asthma | DARTNet Institute | Recruiting | No outcome recorded |
| Phase 4 | NCT06272370 Comparator | Feb → Sep 2024 | asthma, hypersensitivity reaction disease, obstructive lung disease, respiratory tract infectious disorder | DARTNet Institute | Completed | No outcome recorded |
| Phase 4 | NCT05626621 Comparator | Nov 2022 → Aug 2025 overdue | chronic rhinitis | Endeavor Health | Recruiting | No outcome recorded |
| Phase 4 | NCT01676415 Comparator | Aug 2012 → Jan 2016 | chronic rhinosinusitis | Northwestern University | Terminated | No outcome recorded |
| Phase 4 | NCT01118312 Comparator | Sep 2010 → Jun 2014 | asthma, chronic rhinitis, sinusitis | JHSPH Center for Clinical Trials | Completed | No outcome recorded |
| Phase 4 | NCT00361439 Comparator | Aug 2006 → Sep 2008 | seasonal allergic rhinitis | University of Chicago | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00783458 Comparator | Dec 2004 → Jan 2005 | allergic rhinitis | Organon and Co | Completed | No outcome recorded |
| — | NCT06436534 Background | May 2024 → Oct 2026 expected | allergic rhinitis | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2026-07-21 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Receives U.S. FDA Approval to Expand the Use of RYALTRIS® Nasal Spray for Children Aged 6 to Less Than 12 Years glenmarkpharma.com ↗
With this approval, RYALTRIS® is now approved in the United States for adults and pediatric patients aged 6 years and older, extending this treatment option to a younger pediatric population. |
| 2025-11-10 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Secures China Approval For RYALTRIS®, Reinforcing Respiratory Innovation Leadership glenmarkpharma.com ↗
Glenmark Specialty S.A., a wholly-owned subsidiary of Glenmark Pharmaceuticals Ltd., today announced that the National Medical Products Administration (NMPA) of China has approved RYALTRIS® Compound Nasal Spray (GSP 301 NS) for the treatment of Allergic Rhinitis (AR) in adults and children – specifically for treatment of moderate to severe seasonal AR in adults and pediatric patients 6 years of age and older, and moderate to severe perennial AR in adult s and pediatric patients 12 years of age and older. |
| 2022-09-23 | Glenmark Pharmaceuticals Ltd. India | Regulatory Bausch Health and Glenmark Announce the approval of RYALTRIS® in Canada glenmarkpharma.com ↗
RYALTRIS ® (olopatadine hydrochloride and mometasone furoate nasal sp ray) has been approved by Health Canada for the symptomatic treatment of moderate to severe seasonal allergic rhinitis (SAR) and associated ocular symptoms in adults, adolescents, and children aged 6 years and older. |
| 2021-09-30 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark receives marketing approval for Ryaltris®, an innovative combination nasal spray, in 13 countries across the EU and UK glenmarkpharma.com ↗ |
| 2021-09-03 | Novartis Pharmaceuticals | Results Novartis presents new findings at ERS reinforcing the efficacy of Enerzair® Breezhaler®, highlighting its digital companion, as well as showcasing commitment to low carbon footprint asthma solutions novartis.com ↗ |
| 2021-04-26 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark’s Ryaltris ® nasal spray now approved in Europe for the first line treatment of allergic rhinitis in patients over 12 years of age glenmarkpharma.com ↗
Glenmark’s Ryaltris ® nasal spray now approved in Europe for the first line treatment of allergic rhinitis in patients over 12 years of age |
| 2021-02-22 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark’s Ryaltris®- innovative single nasal spray, ready to market in Russia glenmarkpharma.com ↗
Marketing approval received from the Ministry of Health of the Russian Federation |
| 2020-07-10 | Novartis Pharmaceuticals | Results Novartis Phase III IRIDIUM data in Lancet Respiratory Medicine show benefit of Enerzair® Breezhaler® (QVM149), the first-in-class inhaled LABA/LAMA/ICS combination in uncontrolled asthma novartis.com ↗
Once-daily Enerzair® Breezhaler® (QVM149; IND/GLY/MF) was superior to once-daily IND/MF (QMF149) in improving the lung function of patients whose asthma is uncontrolled with LABA/ICS standard-of-care treatment 1 |
| 2020-07-07 | Novartis Pharmaceuticals | Regulatory Novartis receives EC approval for Enerzair® Breezhaler®, including the first digital companion (sensor and app) that can be prescribed alongside a treatment for uncontrolled asthma in the EU novartis.com ↗
European Commission approves once-daily Enerzair ® Breezhaler ® (QVM149; IND/GLY/MF) in the EU, the first-in-class LABA/LAMA/ICS fixed-dose combination for patients whose asthma is uncontrolled with LABA/ICS |
| 2020-06-29 | Novartis Pharmaceuticals | Regulatory Novartis receives simultaneous approval for five new products from Japanese Ministry of Health, Labour and Welfare, offering Japanese patients a broad range of novel treatment options novartis.com ↗ |
| 2020-06-05 | Novartis Pharmaceuticals | Results Novartis Phase IIIb ARGON study meets primary endpoint in a comparison of Enerzair® Breezhaler® (QVM149) versus a free combination of two existing inhaled treatments in uncontrolled asthma novartis.com ↗
Once-daily Enerzair ® Breezhaler ® (QVM149; IND/GLY/MF) met primary endpoint, demonstrating non-inferiority to a free combination of twice-daily Sal/Flu plus once-daily tiotropium (Tio), in improving quality of life in people with uncontrolled asthma 1 . |
| 2020-05-01 | Novartis Pharmaceuticals | Regulatory Novartis receives CHMP positive opinion for Enerzair® Breezhaler® (QVM149), a potential first-in-class inhaled LABA/LAMA/ICS combination for uncontrolled asthma novartis.com ↗
CHMP positive opinion advances efforts to provide first-in-class LABA/LAMA/ICS combination for patients whose asthma is uncontrolled with LABA/ICS standard-of-care treatment in the EU. |
| 2019-12-06 | Novartis Pharmaceuticals | Results Novartis Phase III data on new inhaled dual combination QMF149 show significant improvement across key asthma outcomes versus monotherapy novartis.com ↗
Once-daily QMF149 met primary endpoint of lung function improvement and key secondary endpoint of asthma control improvement versus mometasone furoate |
| 2019-09-30 | Novartis Pharmaceuticals | Results Novartis announces positive results from Phase III PALLADIUM study of inhaled combination QMF149 in patients with uncontrolled asthma novartis.com ↗
Novartis today announced that investigational, once-daily, fixed-dose inhaled QMF149 (indacaterol acetate and mometasone furoate or IND/MF) was superior to mometasone furoate (MF) in improving trough forced expiratory volume in one second (FEV 1 ) after 26 weeks |
| 2019-05-09 | Glenmark Pharmaceuticals Ltd. India | Results Glenmark Pharmaceuticals Announces Results from a Phase 3 Study of Ryaltris™, an Investigational Product for the Treatment of Seasonal Allergic Rhinitis, in Patients Aged 6 to Under 12 Years glenmarkpharma.com ↗ |
| 2017-05-22 | Merck Sharp & Dohme LLC | Results Merck Announces Top-Line Results from the Long Term LABA Safety Study of DULERA (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol merck.com ↗
We are pleased this study met both its primary safety and key secondary efficacy endpoints, |
| 2011-10-24 | Merck Sharp & Dohme LLC | Results Merck Announces Presentation of Phase III Investigational Studies Evaluating DULERA® (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol in Chronic Obstructive Pulmonary Disease (COPD) merck.com ↗
In Study 2, DULERA 200 mcg/10 mcg and DULERA 400 mcg/10 mcg significantly improved AM predose FEV1 at Week 13 compared to treatment with placebo, but neither dose of DULERA reached statistical significance compared to treatment with formoterol 10 mcg. |
All press releases naming this drug 20 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 59 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Mometasone | “participants will use either a combination of budesonide/formoterol or mometasone/formoterol as both controller and rescue therapy or a stand alone inhaled steroid...” NCT06272370 ↗53“Group 1 (n=236) will receive test product Azelastine + Mometasone, nasal spray, 140 mcg + 50 mcg/dose (Sandoz d.d., Slovenia), one actuation in each nostril twice daily,...” NCT05590598 ↗ “Background: Safety and efficacy of GSP301 nasal spray, an investigational fixed-dose combination of olopatadine hydrochloride and mometasone furoate, was established in three...” PMID 31248471 ↗ Jun 2019 “Mometasone furoate monohydrate nasal spray 50 mcg was admininstered intranasally at a dose of 2 sprays in each nostril once daily as rescue medication for rhinoconjunctivitis,...” NCT00562159 ↗ “combination of mometasone furoate 0.1% and Salicylic Acid 5% in patients of both sexes who presented clinical symptoms of psoriasis of mild to moderate.” NCT01229085 ↗ “GSP301 nasal spray is a fixed-dose combination of the antihistamine olopatadine hydrochloride and the corticosteroid mometasone furoate.” PMID 35926824 ↗ Aug 2022 “QVM149 is an investigational drug consisting of 150μg indacaterol acetate, 50μg glycopyrronium bromide and 160μg mometasone furoate.” NCT04206761 ↗ “a combination of budesonide/formoterol or mometasone/formoterol as both controller and rescue therapy” NCT07052942 ↗ “QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device” NCT01636076 ↗ “665 μg of olopatadine and 25 μg of mometasone (twice-daily GSP301)” PMID 30321655 ↗ Oct 2018 “Indacaterol acetate / glycopyrronium bromide / mometasone furoate” NCT03158311 ↗ |
| Known as | LAS 41002 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01119313 ↗ |
| Known as | MFNS | “This study evaluates patient preference and satisfaction with ciclesonide hydrofluoroalkane nasal aerosol (CIC-HFA) compared with mometasone furoate aqueous nasal spray (MFNS).” PMID 24169063 ↗ Nov 20131“To evaluate the effectiveness of mometasone furoate nasal spray (MFNS) in subjects with seasonal allergic rhinitis (SAR).” PMID 16278257 ↗ Nov 2005 |
| Known as | mometasone furoate | “Background: Safety and efficacy of GSP301 nasal spray, an investigational fixed-dose combination of olopatadine hydrochloride and mometasone furoate, was established in three...” PMID 31248471 ↗ Jun 201910“GSP301 nasal spray is a fixed-dose combination of the antihistamine olopatadine hydrochloride and the corticosteroid mometasone furoate intended for seasonal allergic rhinitis...” PMID 30321655 ↗ Oct 2018 “This study evaluates patient preference and satisfaction with ciclesonide hydrofluoroalkane nasal aerosol (CIC-HFA) compared with mometasone furoate aqueous nasal spray (MFNS).” PMID 24169063 ↗ Nov 2013 “GSP301 nasal spray is a fixed-dose combination of the antihistamine olopatadine hydrochloride and the corticosteroid mometasone furoate.” PMID 35926824 ↗ Aug 2022 “fixed-dose combination of the long-acting β2-agonist (LABA) indacaterol maleate and inhaled corticosteroid (ICS) mometasone furoate (MF)” PMID 25649209 ↗ Feb 2015 “Mometasone furoate 220mcg dry powder inhalation is a low-moderate ICS dose that can be given once daily.” NCT03758950 ↗ “QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device” NCT01636076 ↗ “Mometasone furoate 400 mcg by twisthaler, administered 2 hours prior to allergen challenge” NCT01061333 ↗ “One dose (2 sprays in each nostril) of Mometasone Furoate Nasal Spray” NCT00783458 ↗ “Mometasone Furoate/Formoterol Fumarate (MF/F) 100/5 mcg MDI” NCT01566149 ↗ “mometasone furoate (corticosteroid)” PMID 31734334 ↗ Nov 2019 |
| Known as | Mometasone Furoate monohydrate | “Drug: Mometasone Furoate monohydrate” NCT01118312 ↗ |
| Known as | Mometasone Twisthaler | “Mometasone Twisthaler®, 400 µg QD” NCT00941798 ↗ |
| Modality | Other / unclassified | “Topical steroid medication” NCT01676415 ↗ |
| Route | Intranasal | “Mometasone nasal spray 200 mcg/day administered as 2 sprays (50 mcg/spray) in each nostril.” NCT00070707 ↗ |