fluticasone

Trade name: cutivate

Small moleculeapproved

Approved

Dec 14, 1990

Fluticasone furoate, sold under the brand name Flonase Sensimist among others, is a corticosteroid for the treatment of non-allergic and allergic rhinitis administered by a nasal spray. It is also available as an inhaled corticosteroid to help prevent and control symptoms of asthma. It is derived from cortisol. Unlike fluticasone propionate, which is only approved for children four years and older, fluticasone furoate is approved in children as young as two years of age when used for allergies. — Wikipedia

Clinical trial activity

729 trials · 361 clinical orgs · 21 marketing orgs

Phase 1

107

Phase 2

351

Phase 3

243

Phase 4

206

Earliest trial started Aug 11, 1994 (NCT03882047)

Timeline

1990s

Dec 14, 1990
Earliest FDA Approval
Dec 14, 1990
Fougera — NDA Secondary Org
Jan 1, 1994
Earliest Phase 3 Sponsor(trial)

2000s

Aug 24, 2000
GlaxoSmithKline — NDA Secondary Org
Jan 1, 2002
Earliest Phase 2 Sponsor(trial)
May 14, 2004
ANDA Repository — Marketing Organization
May 14, 2004
Padagis Us — Marketing Organization
May 14, 2004
Encube Ethicals Pvt. Ltd. — Marketing Organization
May 14, 2004
Fougera — Marketing Organization
Sep 10, 2004
Nesher Pharms — Marketing Organization
Jan 1, 2005
Earliest Phase 1 Sponsor(trial)
Jun 14, 2005
Taro Pharmaceuticals — Marketing Organization
Feb 22, 2006
West-Ward Pharmaceutical — Marketing Organization
Feb 22, 2006
Hikma — Marketing Organization
Mar 3, 2006
G & W Laboratories Inc. — Marketing Organization
Mar 3, 2006
Cosette — Marketing Organization
Mar 3, 2006
ACP Nimble — Marketing Organization
Apr 27, 2007
GlaxoSmithKline — First NDA Organization
Apr 27, 2007
GlaxoSmithKline — NDA Organization
Sep 12, 2007
Apotex — Marketing Organization
Jan 16, 2008
Akorn, Inc. — Marketing Organization

2010s

May 2, 2011
Glenmark Pharmaceuticals — Marketing Organization
Jan 9, 2012
Wockhardt — Marketing Organization
May 1, 2012
Mylan — NDA Secondary Org
May 10, 2013
GlaxoSmithKline — Marketing Organization
Jul 30, 2013
Perrigo — Marketing Organization
Jan 27, 2017
Teva — NDA Secondary Org
Sep 18, 2017
OptiNose AS — NDA Secondary Org
Jan 30, 2019
Mylan — Marketing Organization
Apr 17, 2019
Hi Tech Pharmaceuticals — Marketing Organization

2020s

Dec 13, 2021
Teva — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Glucocorticoid receptorAGONIST
NR3C1 agonist
- Glucocorticoid receptor (NR3C1) ↗

Combination products

advair diskus
with salmeterol
Also known as advair hfa, airduo digihaler, airduo respiclick, fluticasone propionate/salmeterol (fs), wixela inhub
breo ellipta
with vilanterol
Also known as fluticasone furoate / vilanterol trifenatate 100/25 mcg
dymista
with azelastine
Also known as fluticasone nasal 50 mcg/inh nasal spray, azelastine nasal 140 mcg/inh nasal spray
trelegy ellipta
with umeclidinium, vilanterol
Also known as trelegy

Approval history

approvedDec 14, 1990

Chemistry & pharmacology

Loading structure…

SMILES

C[C@@H]1C[C@H]2[C@@H]3C[C@H](F)C4=CC(=O)C=C[C@]4(C)[C@@]3(F)[C@@H](O)C[C@]2(C)[C@@]1(O)C(=O)SCF

Mol. weight: 444.52 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Availability: Over the Counter

Oral

Parenteral

Topical

Sources

Also known as

adoair250
advair diskus
aerivio spiromax
airflusal forspiro
avamys
avamys
avamys
cci18781
cci18781
cci-18781
cci-18781
cultivate
cultivate
cutivate
cutivate
flixonase
flixonase
flixonase
flixotide
flixotide
flixotide
flixotide
flonase
flonase
flonase
flovent
flovent
flovent
flovent diskus 100
flovent diskus 100
flovent diskus 250
flovent diskus 250
flovent diskus 50
flovent diskus 50
flovent hfa
flovent hfa
fluticasone
fluticasone
fluticasone
fluticasone
fluticasone 17-propionate
fluticasone-formoterol
fluticasone fuorate
fluticasone fuorate
fluticasone furoate
fluticasone furoate
fluticasone furoate
fluticasone furoate
fluticasone furoate
fluticasone furoate
fluticasone furoate
fluticasone furoate
fluticasone furoate
fluticasone furoate
fluticasone furoate
fluticasone furoate / umeclidinium bromide / vilanterol trifenatate
fluticasone furoate, umeclidinium bromide, vilanterol trifenatate
fluticasone furoate / vilanterol
fluticasone furoate / vilanterol
fluticasone furoate / vilanterol trifenatate
fluticasone propionate
fluticasone propionate
fluticasone propionate
fluticasone propionate
fluticasone propionate
fluticasone propionate
fluticasone propionate
fluticasone propionate
fluticasone propionate
fluticasone proprionate
fluticasone proprionate
fluticasone proprionate
fluticasone proprionate
fluticasone proprionate
fluticasone proprionate
fluticasonum furoas
fluticasonum furoas
flutiform
flutiform
flutiform
furoate de fluticasone
furoate de fluticasone
furoato de fluticasona
furoato de fluticasona
gw685698
gw685698
gw685698x
gw685698x
gw685698x
msrd-100
nasofan
pf-04764793
pirinase
pirinase
salmeterol / fluticasone propionate
salmeterol xinafoate / fluticasone propionate
sereflo
seretide
seretide
seretide 100
seretide 125
seretide 250
seretide 50
seretide 500
sirdupla
tv48108
veramyst
veramyst
veramyst
vr506

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT06234345	Phase 3	Feb 28, 2026	Eurofarma Laboratorios S.A.
NCT06983665	N/A	May 25, 2025	Government of China, Jinan University
NCT06850805	Phase 3	Apr 18, 2025	OptiNose AS
NCT06705387	Phase 2	Dec 31, 2024	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Colorado, Denver
NCT05776927	Phase 3	Dec 23, 2024	Novartis
NCT06676319	Phase 2	Nov 11, 2024	Sanofi
NCT06664619	Phase 3	Nov 7, 2024	Teva
NCT06636240	N/A	Nov 1, 2024	Taipei Medical University
NCT07110740	Phase 1	Oct 24, 2024	Korea United Pharm. Inc.
NCT06474039	Phase 3	Jun 30, 2024	Mahidol University
NCT06482294	Phase 2	Jun 18, 2024	University of Ferrara
NCT06290102	Phase 1	May 7, 2024	Teva
NCT05922761	Phase 2	Dec 31, 2023	Harvard University, National Heart, Lung, and Blood Institute (NHLBI), Sanofi
NCT06040268	Phase 1/Phase 2 (Phase 2)	Dec 12, 2023	Department of Defense, University of Colorado, Denver
NCT06066606	N/A	Oct 5, 2023	University of Copenhagen
NCT06077019	N/A	Oct 5, 2023	University of Copenhagen
NCT05684380	Phase 3	Sep 30, 2023	EMS S/A
NCT06052267	Phase 3	Aug 30, 2023	Teva
NCT06025214	Phase 1	Aug 22, 2023	BECRO Ltd., Respirent Pharmaceuticals Co Ltd.
NCT06858423	Phase 4	Aug 15, 2023	Benha University

Showing 20 of 729 trials

Page 1 / 37

Organizations

Research & Development (361)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
GlaxoSmithKline	For profit	278	233	5	1998
Novartis	For profit	26	25	4	2004
Teva	For profit	26	20	5	2004
Merck	For profit	19	16	4	1994
AstraZeneca	For profit	17	12	4	2003
Mundipharma	For profit	17	17	4	2007
Respirent Pharmaceuticals Co Ltd.	For profit	16	16	2	2018
BECRO Ltd.	For profit	15	0	2	2018
Boehringer Ingelheim	For profit	15	14	4	2003
University of Dundee	Academic/Hospital	15	14	1	2004
National Heart, Lung, and Blood Institute (NHLBI)	Government	13	1	4	2000
Meda	For profit	10	9	4	2007
OptiNose AS	For profit	10	10	2	2013
Pfizer	For profit	10	10	2	2009
University of Chicago	Academic/Hospital	10	9	2	2005
University of Colorado, Denver	Academic/Hospital	10	4	4	2003
Chiesi	For profit	9	9	3	2004
Sanofi	For profit	9	6	4	2006
SkyePharma AG	For profit	9	9	3	2004
Parexel	For profit	8	0	4	2010

361 organizations

Page 1 / 19

Marketing (36)

Organization	Org type	Relationship	Date
ACP Nimble	For profit	MKTG	Mar 3, 2006
ANDA Repository	For profit	MKTG	May 14, 2004
Akorn, Inc.	For profit	MKTG	Jan 16, 2008
Apotex	For profit	MKTG	Sep 12, 2007
Apotex	For profit	SYN	Feb 29, 2016
Cosette	For profit	MKTG	Mar 3, 2006
Encube Ethicals Pvt. Ltd.	For profit	MKTG	May 14, 2004
Fougera	For profit	NDA2	Dec 14, 1990
Fougera	For profit	SYN	Dec 14, 1990
Fougera	For profit	MKTG	May 14, 2004
G & W Laboratories Inc.	For profit	MKTG	Mar 3, 2006
GlaxoSmithKline	For profit	NDA2	Aug 24, 2000
GlaxoSmithKline	For profit	SYN	Oct 19, 1994
GlaxoSmithKline	For profit	SYN	Jul 23, 2014
GlaxoSmithKline	For profit	MKTG	May 10, 2013
GlaxoSmithKline	For profit	NDA	Apr 27, 2007
Glenmark Pharmaceuticals	For profit	MKTG	May 2, 2011
Hi Tech Pharmaceuticals	For profit	MKTG	Apr 17, 2019
Hi Tech Pharmaceuticals	For profit	SYN	Jan 16, 2008
Hikma	For profit	MKTG	Feb 22, 2006
Hikma	For profit	MKTG	Feb 22, 2006
Mylan	For profit	MKTG	Jan 30, 2019
Mylan	For profit	SYN	May 1, 2012
Mylan	For profit	SYN	Jan 30, 2019
Mylan	For profit	NDA2	May 1, 2012
Nesher Pharms	For profit	MKTG	Sep 10, 2004
OptiNose AS	For profit	NDA2	Sep 18, 2017
Padagis Us	For profit	MKTG	May 14, 2004
Perrigo	For profit	MKTG	Jul 30, 2013
Perrigo	For profit	SYN	May 14, 2004
Perrigo	For profit	SYN	Feb 18, 2021
Taro Pharmaceuticals	For profit	MKTG	Jun 14, 2005
Teva	For profit	NDA2	Jan 27, 2017
Teva	For profit	MKTG	Dec 13, 2021
West-Ward Pharmaceutical	For profit	MKTG	Feb 22, 2006
Wockhardt	For profit	MKTG	Jan 9, 2012