mometasone
Trade name: elocon
Approved
Apr 30, 1987
Mometasone is a medium-potency synthetic corticosteroid with antiinflammatory, antipruritic, and vasoconstrictive properties. Studies in asthmatic patients have demonstrated that mometasone provides a favorable ratio of topical to systemic activity due to its primary local effect along with the extensive hepatic metabolism and the lack of active metabolites. Though effective for the treatment of asthma, glucocorticoids do not affect asthma symptoms immediately. Maximum improvement in symptoms following inhaled administration of mometasone furoate may not be achieved for 1 to 2 weeks or longer after starting treatment. When glucocorticoids are discontinued, asthma stability may persist for several days or longer. Mometasone has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor which is approximately 12 times that of dexamethasone, 7 times that of triamcinolone acetonide, 5 times that of budesonide, and 1.5 times that of fluticasone. Mometasone inhaler is indicated for the maintenance treatment of asthma as prophylactic therapy. The nasal spray is indicated for the treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis. ELOCON Lotion (Mometasone) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. — NCATS
Clinical trial activity
214 trials · 136 clinical orgs · 18 marketing orgs
Earliest trial started Aug 23, 1993 (NCT03855189)
Timeline
1980s
- Apr 30, 1987
Schering-Plough — Earliest FDA Approval
- Apr 30, 1987
Schering-Plough — NDA Organization
- Apr 30, 1987
Merck — NDA Secondary Org
1990s
2000s
- Mar 18, 2002
Padagis Us — Marketing Organization
- Jan 1, 2003
- Nov 14, 2003
ANDA Repository — Marketing Organization
- Nov 14, 2003
Encube Ethicals Pvt. Ltd. — Marketing Organization
- Dec 3, 2004
Taro Pharmaceuticals — Marketing Organization
- Mar 28, 2005
Fougera — Marketing Organization
- Apr 6, 2005
Perrigo — Marketing Organization
- Jan 1, 2006
Earliest Phase 1 Sponsor(trial)
- May 22, 2006
Cosette — Marketing Organization
- May 22, 2006
ACP Nimble — Marketing Organization
- May 22, 2006
G & W Laboratories Inc. — Marketing Organization
- May 28, 2008
Glenmark Pharmaceuticals — Marketing Organization
2010s
- Mar 22, 2016
Apotex — Marketing Organization
- Apr 3, 2017
Amneal Pharmaceuticals — Marketing Organization
- Dec 8, 2017
Intersect ENT — NDA Secondary Org
- Jul 13, 2018
Torrent Pharmaceuticals Limited — Marketing Organization
2020s
- Jan 13, 2022
Glenmark Pharmaceuticals — NDA Secondary Org
- Mar 17, 2022
Perrigo — NDA Secondary Org
- Mar 18, 2024
Aurobindo Pharma — Marketing Organization
Indications
Approved for
Studied for
- Adenoidectomy · Phase 4
- Adenoids · Phase 4
- Allergy and Immunology · Phase 3
- Alopecia Areata · Phase 4
- Anemia, Sickle Cell · Phase 2
- Anosmia · Phase 3
- Biological Therapy · Phase 4
- Biomarkers · Phase 4
- Breast Neoplasms · Phase 3
- Choanal Atresia · Phase 4
- Conjunctivitis · Phase 3
- COVID-19 · Phase 3
- Dermatitis, Atopic · Phase 4
- Dermatology · Phase 3
- Drug-Related Side Effects and Adverse Reactions · Phase 3
- Eczema · Phase 4
- Enuresis · Phase 4
- Eosinophilic Esophagitis · Phase 2
- Healthy Volunteers · Phase 1
- Hypersensitivity · Phase 3
- Inflammation · Phase 2
- Nasal Obstruction · Phase 4
- Nasal Polyps · Phase 4
- Olfaction Disorders · Phase 3
- Otitis Media with Effusion · Phase 3
- Pemphigoid, Bullous · Phase 2
- Phimosis · Phase 4
- Pruritus · Phase 3
- Psoriasis · Phase 4
- Pulmonary Disease, Chronic Obstructive · Phase 3
- Radiodermatitis · Phase 4
- Rhinitis · Phase 4
- Rhinitis, Allergic · Phase 4
- Rhinitis, Allergic, Perennial · Phase 4
- Sinusitis · Phase 4
- Sleep Apnea, Obstructive · Phase 4
- Sleep Apnea Syndromes · Phase 4
- Sleep Disorders, Intrinsic · Phase 4
- Sleep Wake Disorders · Phase 4
- Sneezing · Phase 3
- Snoring · Phase 4
- Spinal Cord Injuries · Phase 1
- Tonsillitis · Phase 4
- Vitiligo · Phase 4
Mechanism of action
- Glucocorticoid receptorAGONIST
NR3C1 agonist
Combination products
dulera
with formoterol
ryaltris
with olopatadine
Approval history
- approvedApr 30, 1987
Chemistry & pharmacology
SMILES
C[C@@H]1C[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@]4(C)[C@@]3(Cl)[C@@H](O)C[C@]2(C)[C@@]1(O)C(=O)CCl- Mol. weight
- 427.361 g/mol
- Lipinski Ro5
- 1 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral, Topical
- Availability
- Over the Counter
Oral
No
Parenteral
Yes
Topical
Yes
Sources
- WikipediaMometasone/formoterol ↗
- NCATS8HR4QJ6DW8 ↗
- ChEMBLCHEMBL1201404 ↗
- ChEMBLCHEMBL1161 ↗
- WikipediaMometasone ↗
Also known as
- asmanex
- asmanex
- asmanex
- asmanex twisthaler
- asmanex twisthaler
- crx-191
- dulera
- dulera
- ecural
- elocon
- elocon
- elocon
- elomet
- mk-0887
- mometason
- mometason
- mometasona
- mometasona
- mometasone
- mometasone
- mometasone
- mometasone
- mometasone
- mometasone
- (+)-mometasone
- (+)-mometasone
- mométasone
- mométasone
- mometasone furoate
- mometasone furoate
- mometasone furoate
- mometasone furoate
- mometasone furoate
- mometasone furoate
- mometasone furoate hydrate
- mometasone furoate hydrate
- mometasone furoate hydrate
- mometasone furoate hydrate
- mometasone furoate hydrate
- mometasone furoate hydrate
- mometasone furoate monohydrate
- mometasone furoate monohydrate
- mometasone furoate monohydrate
- mometasonum
- mometasonum
- nasonex
- nasonex
- nasonex
- nasonex
- qvm149
- sch-32088
- sch-32088
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07114107 | N/A | Aug 31, 2025 | First People's Hospital of Hangzhou, Huzhou University, Zhejiang University |
| NCT07016113 | Phase 2 | Jul 1, 2025 | Government of Indonesia, Padjadjaran University |
| NCT06914908 | Phase 2 | May 12, 2025 | Sanofi |
| NCT06834347 | Phase 3 | Feb 12, 2025 | Regeneron, Sanofi |
| NCT06834360 | Phase 3 | Feb 6, 2025 | Regeneron, Sanofi |
| NCT06801353 | Phase 4 | Feb 1, 2025 | Capital Medical University |
| NCT06691113 | Phase 2 | Nov 18, 2024 | Regeneron, Sanofi |
| NCT06399783 | Phase 4 | Oct 1, 2024 | Assiut University |
| NCT07016763 | Early Phase 1 (Phase 1) | Sep 1, 2024 | Isola Tiberina - Gemelli Isola Hospital, Rome, Italy |
| NCT07311759 | Phase 3 | Aug 17, 2024 | Cairo University |
| NCT06436534 | N/A | May 24, 2024 | Huazhong University of Science and Technology |
| NCT06147921 | Phase 1 | Dec 15, 2023 | Diceros Therapeutics |
| NCT06013241 | Phase 2 | Oct 30, 2023 | Insmed, Inc. |
| NCT06126952 | Phase 2 | Oct 30, 2023 | Cliantha Research Limited, Meda Pharmaceuticals |
| NCT06067100 | N/A | Oct 5, 2023 | University of Copenhagen |
| NCT06077019 | N/A | Oct 5, 2023 | University of Copenhagen |
| NCT06200766 | Phase 3 | Aug 25, 2023 | Huazhong University of Science and Technology |
| NCT05919316 | N/A | Jul 4, 2023 | National University of Malaysia |
| NCT05887843 | Phase 1 | Jun 8, 2023 | Sandoz |
| NCT05562466 | Phase 3 | Apr 7, 2023 | Novartis |
Organizations
Research & Development (136)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Merck | For profit | 65 | 60 | 5 | 1993 |
| Novartis | For profit | 24 | 18 | 3 | 2006 |
| Sanofi | For profit | 9 | 9 | 2 | 2013 |
| Schering-Plough | For profit | 9 | 2 | 4 | 2003 |
| Regeneron | For profit | 8 | 0 | 2 | 2013 |
| Glenmark Pharmaceuticals | For profit | 6 | 6 | 2 | 2014 |
| Lyra Therapeutics | For profit | 4 | 4 | 2 | 2019 |
| National Heart, Lung, and Blood Institute (NHLBI) | Government | 4 | 0 | 3 | 2010 |
| Sandoz | For profit | 4 | 4 | 2 | 2009 |
| Capital Medical University | Academic/Hospital | 3 | 2 | 2 | 2021 |
| EMS S/A | For profit | 3 | 3 | 1 | 2017 |
| Ghent University | Academic/Hospital | 3 | 2 | 2 | 2010 |
| GlaxoSmithKline | For profit | 3 | 3 | 2 | 2005 |
| Intersect ENT | For profit | 3 | 3 | 2 | 2013 |
| Northwestern University | Academic/Hospital | 3 | 2 | 3 | 2012 |
| Sunovion | For profit | 3 | 3 | 2 | 2011 |
| University of Chicago | Academic/Hospital | 3 | 3 | 2 | 2006 |
| University of Copenhagen | Academic/Hospital | 3 | 3 | 2 | 2022 |
| Zalicus | For profit | 3 | 3 | 2 | 2007 |
| ALK-Abello, S.A. | For profit | 2 | 2 | 1 | 2007 |
Marketing (29)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ACP Nimble | For profit | MKTG | May 22, 2006 |
| ANDA Repository | For profit | MKTG | Nov 14, 2003 |
| Amneal Pharmaceuticals | For profit | MKTG | Apr 3, 2017 |
| Amneal Pharmaceuticals | For profit | SYN | Jun 14, 2023 |
| Apotex | For profit | MKTG | Mar 22, 2016 |
| Apotex | For profit | SYN | Mar 22, 2016 |
| Aurobindo Pharma | For profit | MKTG | Mar 18, 2024 |
| Cosette | For profit | MKTG | May 22, 2006 |
| Encube Ethicals Pvt. Ltd. | For profit | MKTG | Nov 14, 2003 |
| Fougera | For profit | MKTG | Mar 28, 2005 |
| G & W Laboratories Inc. | For profit | MKTG | May 22, 2006 |
| Glenmark Pharmaceuticals | For profit | SYN | May 28, 2008 |
| Glenmark Pharmaceuticals | For profit | SYN | Aug 9, 2010 |
| Glenmark Pharmaceuticals | For profit | SYN | Jan 13, 2022 |
| Glenmark Pharmaceuticals | For profit | MKTG | May 28, 2008 |
| Glenmark Pharmaceuticals | For profit | NDA2 | Jan 13, 2022 |
| Intersect ENT | For profit | NDA2 | Dec 8, 2017 |
| Merck | For profit | NDA2 | Apr 30, 1987 |
| Organon | For profit | MKTG | Oct 1, 1997 |
| Organon | For profit | NDA2 | Oct 1, 1997 |
| Padagis Us | For profit | MKTG | Apr 6, 2005 |
| Padagis Us | For profit | MKTG | Mar 18, 2002 |
| Perrigo | For profit | MKTG | Apr 6, 2005 |
| Perrigo | For profit | SYN | Mar 18, 2002 |
| Perrigo | For profit | SYN | Mar 17, 2022 |
| Perrigo | For profit | NDA2 | Mar 17, 2022 |
| Schering-Plough | For profit | NDA | Apr 30, 1987 |
| Taro Pharmaceuticals | For profit | MKTG | Dec 3, 2004 |
| Torrent Pharmaceuticals Limited | For profit | MKTG | Jul 13, 2018 |