Mometasone - PharmaKB

Mometasone furoate

Asmanex, Breezhaler, Dulera, Mometasone Furoate, Nasonex, Ryaltris, Sinuva (mometasone furoate) is a small molecule pharmaceutical. Mometasone furoate was first approved as Elocon on 1987-04-30. It is used to treat allergic rhinitis perennial, facial dermatoses, foot dermatoses, hand dermatoses, and inflammation amongst others in the USA. It has been approved in Europe to treat asthma.

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Variants

Financial

Trends

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
respiratory tract diseases	D012140
otorhinolaryngologic diseases	D010038
skin and connective tissue diseases	D017437
immune system diseases	D007154
signs and symptoms pathological conditions	D013568

Trade Name

FDA

EMA

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Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

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Labels

FDA

EMA

Brand Name	Status	Last Update
allergy	New Drug Application	2024-08-29
allergy nasal	New Drug Application	2024-08-28
asmanex	New Drug Application	2025-02-11
asmanex hfa	New Drug Application	2024-11-20
basic care allergy	New Drug Application	2024-08-28
childrens nasonex	New Drug Application	2024-08-28
dulera	New Drug Application	2025-02-10
elocon	New Drug Application	2010-08-31
hyaluronic acid sodium salt 2% / mometasone furoate 0.1% / niacinamide 4%	unapproved drug other	2019-05-21
leader allergy nasal	New Drug Application	2024-12-02

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Indications

FDA

EMA

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Agency Specific

FDA

EMA

Expiration	Code
MOMETASONE FUROATE / OLOPATADINE HYDROCHLORIDE, RYALTRIS, GLENMARK SPECIALTY
2025-01-13	NP
FORMOTEROL FUMARATE / MOMETASONE FUROATE, DULERA, ORGANON LLC
2023-02-12	PED
MOMETASONE FUROATE, ASMANEX HFA, ORGANON LLC
2023-02-12	PED

Patent Expiration

Patent	Expires	Flag	FDA Information
Mometasone Furoate, Sinuva, Intersect Ent Inc
10232152	2034-11-24	DP	U-2272
10406332	2034-03-13	DP
8763222	2032-02-08	DP
10357640	2031-10-03		U-2272
8025635	2027-06-12	DP	U-2272
7544192	2026-11-29		U-2272
9585681	2026-04-04		U-2272
7662141	2024-03-12		U-2272
7713255	2024-03-12		U-2272
7951130	2024-03-12		U-2272
7951131	2024-03-12		U-2272
7951133	2024-03-12		U-2272
8109918	2024-03-12		U-2272
Mometasone Furoate / Olopatadine Hydrochloride, Ryaltris, Glenmark Specialty
9078923	2034-09-04	DP	U-3297
9370483	2034-09-04	DP
9750754	2034-09-04	DP	U-3297
9937189	2034-09-04	DP
10016443	2034-09-04		U-3297
10376526	2034-09-04	DP
10517880	2034-09-04	DP	U-3297
10548907	2034-09-04		U-3297
10561672	2034-09-04	DP
10646500	2034-09-04		U-3297
10758550	2034-09-04		U-3296
10765686	2034-09-04		U-3295
11400101	2034-09-04		U-3297

ATC Codes

No data

HCPCS

Code	Description
J7402	Mometasone furoate sinus implant, (sinuva), 10 micrograms

Clinical

Clinical Trials

327 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Rhinitis	D012220	EFO_0008521	J31	5	8	42	19	12	84
Allergic rhinitis	D065631	—	J30.9	5	8	40	16	11	78
Asthma	D001249	EFO_0000270	J45	1	16	23	17	13	70
Sinusitis	D012852	EFO_0007486	J32	2	14	13	8	8	44
Rhinosinusitis	D000096825	—	—	2	10	13	6	7	37
Allergic rhinitis seasonal	D006255	EFO_0003956	J30	3	6	21	5	2	36
Nasal polyps	D009298	—	J33	—	12	16	6	1	33
Polyps	D011127	EFO_0000662	—	—	6	10	2	1	18
Allergic rhinitis perennial	D012221	EFO_1001417	J30.89	—	1	13	3	1	18
Dermatitis	D003872	—	L30.9	2	3	1	4	2	12

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Paranasal sinus diseases	D010254	—	—	2	5	7	—	4	17
Chronic obstructive pulmonary disease	D029424	EFO_0000341	J44.9	—	1	3	—	2	6
Colorectal neoplasms	D015179	—	—	—	2	2	—	1	5
Nasopharyngeal neoplasms	D009303	—	—	—	2	2	—	—	4
Achondroplasia	D000130	—	Q77.4	—	2	1	—	1	4
Chronic disease	D002908	—	—	—	1	3	—	—	4
Breast neoplasms	D001943	EFO_0003869	C50	—	—	2	—	1	3
Conjunctivitis	D003231	—	H10	—	—	2	—	—	2
Prostatic neoplasms	D011471	—	C61	—	—	2	—	—	2
Castration-resistant prostatic neoplasms	D064129	—	—	—	—	2	—	—	2

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Eosinophilic esophagitis	D057765	EFO_0004232	K20.0	—	2	—	—	—	2
Esophagitis	D004941	HP_0100633	K20	—	2	—	—	—	2
Sickle cell anemia	D000755	EFO_0000697	D57	—	2	—	—	—	2
Parkinson disease	D010300	EFO_0002508	G20	1	1	—	—	—	1
Ulcerative colitis	D003093	EFO_0000729	K51	—	1	—	—	—	1
Colitis	D003092	EFO_0003872	K52.9	—	1	—	—	—	1
Ulcer	D014456	MPATH_579	—	—	1	—	—	—	1
Bullous pemphigoid	D010391	EFO_0007187	L12	—	1	—	—	—	1
Critical illness	D016638	—	—	—	1	—	—	—	1
Malnutrition	D044342	EFO_0008572	E40-E46	—	1	—	—	—	1

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	3	—	—	—	2	5
Spinal cord injuries	D013119	EFO_1001919	—	1	—	—	—	4	5
Wounds and injuries	D014947	—	T14.8	1	—	—	—	3	4

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Malocclusion	D008310	—	M26.4	—	—	—	—	4	4
Stroke	D020521	EFO_0000712	I63.9	—	—	—	—	3	3
Obesity	D009765	EFO_0001073	E66.9	—	—	—	—	3	3
Overweight	D050177	—	E66.3	—	—	—	—	2	2
Syndrome	D013577	—	—	—	—	—	—	2	2
Head and neck neoplasms	D006258	—	—	—	—	—	—	1	1
Hemorrhage	D006470	MP_0001914	R58	—	—	—	—	1	1
Pharyngitis	D010612	—	R07.0	—	—	—	—	1	1
Intratracheal intubation	D007442	—	—	—	—	—	—	1	1
Multiple sclerosis	D009103	EFO_0003885	G35	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Mometasone furoate
INN	—
Description	Mometasone furoate is a 2-furoate ester, a steroid ester, an 11beta-hydroxy steroid, a 20-oxo steroid, an organochlorine compound and a 3-oxo-Delta(1),Delta(4)-steroid. It has a role as an anti-inflammatory drug and an anti-allergic agent. It is functionally related to a mometasone.
Classification	Small molecule
Drug class	Corticosteroid; Glucocorticoid
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	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(OC(=O)c1ccco1)C(=O)CCl

Identifiers

PDB	—
CAS-ID	83919-23-7
RxCUI	—
ChEMBL ID	CHEMBL1161
ChEBI ID	47564
PubChem CID	441336
DrugBank	DB00764
UNII ID	—

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Variants

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Financial

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Asmanex – Organon

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Nasonex – Organon

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Nasonex – Merck & Co

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Dulera – Organon

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Dulera – Merck & Co

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Estimated US medical usage

Mometasone furoate

Formoterol

Mometasone

Total medical expenditures per year (USD, in millions)

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Mometasone furoate

Mometasone

Total medical expenditures per year (USD, in millions)

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Safety

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Adverse Events

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21,433 adverse events reported

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