Triamcinolone

Aristocort, Kenacort, Kenalog, Myco-triacet, Mycolog-ii, Mytrex, Nasacort, Triesence, Xipere, Zilretta (triamcinolone) is a small molecule pharmaceutical. Triamcinolone was first approved as Aristocort on 1982-01-01. It is used to treat adrenal insufficiency, allergic rhinitis perennial, ankylosing spondylitis, atopic dermatitis, and berylliosis amongst others in the USA. The pharmaceutical is active against glucocorticoid receptor.

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
infections	D007239
musculoskeletal diseases	D009140
digestive system diseases	D004066
respiratory tract diseases	D012140
otorhinolaryngologic diseases	D010038
nervous system diseases	D009422
eye diseases	D005128
urogenital diseases	D000091642
hemic and lymphatic diseases	D006425
hereditary congenital and neonatal diseases and abnormalities	D009358

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Trade Name

FDA

EMA

Kenalog, Nasacort, Triesence, Xipere, Zilretta (generic drugs available since 1982-01-01, discontinued: Allernaze, Aristocort, Aristocort a, Aristogel, Azmacort, Flutex, Kenacort, Oralone, Triacet, Triacort, Triatex, Trivaris, Trymex)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Triamcinolone

Tradename	Company	Number	Date	Products
ARISTOCORT	Astellas Pharma	N-011161 DISCN	1982-01-01	5 products
KENACORT	Delcor Asset	N-011283 DISCN	1982-01-01	4 products

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Triamcinolone acetonide

Tradename	Company	Number	Date	Products
KENALOG-10	Bristol Myers Squibb	N-012041 RX	1982-01-01	1 products, RLD
KENALOG-80	Bristol Myers Squibb	N-014901 RX	2019-04-12	1 products, RLD, RS
KENALOG-40	Bristol Myers Squibb	N-014901 RX	1982-01-01	1 products, RLD, RS
XIPERE	Bausch Health Companies	N-211950 RX	2021-10-22	1 products, RLD, RS
NASACORT ALLERGY 24 HOUR	Sanofi	N-020468 OTC	2013-10-11	1 products, RLD, RS
TRIESENCE	Novartis	N-022048 RX	2007-11-29	1 products, RLD, RS
ZILRETTA	Pacira BioSciences	N-208845 RX	2017-10-06	1 products, RLD, RS
KENALOG	Sun Pharmaceutical Industries	N-012104 RX	1982-01-01	1 products, RLD, RS

Show 10 discontinued

Triamcinolone diacetate

Tradename	Company	Number	Date	Products
ARISTOCORT	Astellas Pharma	N-011960 DISCN	1982-01-01	1 products
KENACORT	Delcor Asset	N-012515 DISCN	1982-01-01	1 products
ARISTOCORT	Fosun Pharmaceutical	N-011685 DISCN	1982-01-01	1 products
ARISTOCORT	Fosun Pharmaceutical	N-012802 DISCN	1982-01-01	1 products, RLD

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Labels

FDA

EMA

Brand Name	Status	Last Update
allernaze	New Drug Application	2010-11-23
lidolog kit	unapproved drug other	2023-05-15
nasacort allergy 24hr	New Drug Application	2022-04-20
oralone	ANDA	2019-01-14
triamcinolone acetonide	ANDA	2023-06-19
trianex 0.05%	ANDA	2021-05-12
triderm	ANDA	2023-02-13
triesence	New Drug Application	2020-10-02
xipere	New Drug Application	2021-10-25
xuriden	New Drug Application	2019-12-16

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Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
adrenal insufficiency	—	D000309	—
allergic rhinitis perennial	EFO_1001417	D012221	J30.89
ankylosing spondylitis	EFO_0003898	D013167	M45
atopic dermatitis	EFO_0000274	D003876	L20
berylliosis	EFO_0007168	D001607	J63.2
bronchial spasm	—	D001986	—
dermatitis herpetiformis	—	D003874	L13.0
erythema multiforme	—	D004892	L51
facial dermatoses	—	D005148	—
foot dermatoses	—	D005533	—

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Agency Specific

FDA

EMA

Expiration	Code
TRIAMCINOLONE ACETONIDE, XIPERE, BAUSCH AND LOMB INC
2024-10-22	NP

Patent Expiration

Patent	Expires	Flag	FDA Information
Triamcinolone Acetonide, Xipere, Bausch And Lomb Inc
9937075	2034-05-02	DP
9636332	2033-11-08		U-3234
8636713	2027-05-02		U-3234
Triamcinolone Acetonide, Zilretta, Pacira Pharms Inc
8828440	2031-08-04	DP
9555048	2031-08-04		U-2151
Triamcinolone Acetonide, Triesence, Novartis
8128960	2029-12-17	DP
8211880	2029-03-10		U-1257, U-1258

ATC Codes

A: Alimentary tract and metabolism drugs

— A01: Stomatological preparations

— A01A: Stomatological preparations

— A01AC: Corticosteroids for local oral treatment

— A01AC01: Triamcinolone

C: Cardiovascular system drugs

— C05: Vasoprotectives

— C05A: Agents for treatment of hemorrhoids and anal fissures for topical use

— C05AA: Corticosteroids, topical for treatment of hemorrhoids and anal fissures

— C05AA12: Triamcinolone

D: Dermatologicals

— D07: Corticosteroids, dermatological preparations

— D07A: Corticosteroid dermatological preparations, plain

— D07AB: Corticosteroids, moderately potent (group ii)

— D07AB09: Triamcinolone

— D07B: Corticosteroids, combinations with antiseptics

— D07BB: Corticosteroids, moderately potent, combinations with antiseptics

— D07BB03: Triamcinolone and antiseptics

— D07C: Corticosteroids, combinations with antibiotics

— D07CB: Corticosteroids, moderately potent, combinations with antibiotics

— D07CB01: Triamcinolone and antibiotics

— D07X: Corticosteroids, other combinations

— D07XB: Corticosteroids, moderately potent, other combinations

— D07XB02: Triamcinolone

H: Systemic hormonal preparations, excl. sex hormones and insulins

— H02: Corticosteroids for systemic use

— H02A: Corticosteroids for systemic use, plain

— H02AB: Glucocorticoids, systemic

— H02AB08: Triamcinolone

R: Respiratory system drugs

— R01: Nasal preparations

— R01A: Decongestants and other nasal preparations for topical use

— R01AD: Corticosteroid nasal preparations for topical use

— R01AD11: Triamcinolone

— R03: Drugs for obstructive airway diseases

— R03B: Other drugs for obstructive airway diseases, inhalants in atc

— R03BA: Glucocorticoid inhalants for obstructive airway disease

— R03BA06: Triamcinolone

S: Sensory organ drugs

— S01: Ophthalmologicals

— S01B: Antiinflammatory agents, ophthalmologic

— S01BA: Corticosteroid ophthalmologic antiinflammatory agents, plain

— S01BA05: Triamcinolone

— S02: Otologicals

— S02C: Corticosteroids and antiinfectives in combination, otologic

— S02CA: Corticosteroids and antiinfectives in combination

— S02CA04: Triamcinolone and antiinfectives

HCPCS

Code	Description
J3300	Injection, triamcinolone acetonide, preservative free, 1 mg
J3301	Injection, triamcinolone acetonide, not otherwise specified, 10 mg
J3302	Injection, triamcinolone diacetate, per 5 mg
J3303	Injection, triamcinolone hexacetonide, per 5 mg
J3304	Injection, triamcinolone acetonide, preservative-free, extended-release, microsphere formulation, 1 mg
J7683	Triamcinolone, inhalation solution, compounded product, administered through dme, concentrated form, per milligram
J7684	Triamcinolone, inhalation solution, compounded product, administered through dme, unit dose form, per milligram

Clinical

Clinical Trials

52 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Sleep initiation and maintenance disorders	D007319		F51.01	—	—	3	2	3	8
Major depressive disorder	D003865	EFO_0003761	F22	—	1	2	1	1	5
Obstructive sleep apnea	D020181	EFO_0003918	G47.33	2	1	—	1	1	4
Delirium	D003693		R41.0	—	—	—	2	1	3
Sleep apnea syndromes	D012891	EFO_0003877	G47.3	—	1	—	2	—	3
Sleep wake disorders	D012893		G47	—	—	2	1	—	3
Schizophrenia	D012559	EFO_0000692	F20	—	—	1	1	—	2
Substance-related disorders	D019966	EFO_0003890	F13	—	—	—	1	1	2
Cognitive dysfunction	D060825		G31.84	—	—	—	1	1	2
Spinal cord injuries	D013119	EFO_1001919		—	1	—	1	—	2

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Depression	D003863		F33.9	2	1	2	—	1	5
Treatment-resistant depressive disorder	D061218			—	—	1	—	1	2
Alzheimer disease	D000544	EFO_0000249	F03	—	—	2	—	—	2
Dementia	D003704		F03	—	—	1	—	—	1
Psychophysiologic disorders	D011602		F45.9	—	—	1	—	—	1
Anxiety disorders	D001008	EFO_0006788	F41.1	—	—	1	—	—	1
Amyotrophic lateral sclerosis	D000690	EFO_0000253	G12.21	—	1	1	—	—	1
Opioid-related disorders	D009293	EFO_0005611	F11	—	—	1	—	—	1
Chronic kidney failure	D007676	EFO_0003884	N18.6	—	—	1	—	—	1
Sleep	D012890	GO_0030431		—	—	1	—	—	1

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Diabetic neuropathies	D003929	EFO_1000783		—	2	—	—	—	2
Alcoholism	D000437	EFO_0003829	F10.1	—	1	—	—	—	1
Amnesia	D000647	EFO_1001454	F44.0	—	1	—	—	—	1

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—			7	—	—	—	—	7
Central sleep apnea	D020182		G47.31	1	—	—	—	—	1
Pharmacokinetics	D010599			1	—	—	—	—	1
Biological availability	D001682			1	—	—	—	—	1
Postpartum depression	D019052	EFO_0007453	F53.0	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Wounds and injuries	D014947		T14.8	—	—	—	—	1	1
Pain	D010146	EFO_0003843	R52	—	—	—	—	1	1
Chronic disease	D002908			—	—	—	—	1	1
Brain injuries	D001930		S06.9	—	—	—	—	1	1
Alcohol-related disorders	D019973		F10	—	—	—	—	1	1
Post-traumatic stress disorders	D013313	EFO_0001358	F43.1	—	—	—	—	1	1
Suicidal ideation	D059020	EFO_0004320	R45.851	—	—	—	—	1	1
Sepsis-associated encephalopathy	D065166		G93.41	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	TRIAMCINOLONE
INN	triamcinolone
Description	Triamcinolone is a C21-steroid hormone that is 1,4-pregnadiene-3,20-dione carrying four hydroxy substituents at positions 11beta, 16alpha, 17alpha and 21 as well as a fluoro substituent at position 9. Used in the form of its 16,17-acetonide to treat various skin infections. It has a role as an anti-allergic agent and an anti-inflammatory drug. It is a fluorinated steroid, an 11beta-hydroxy steroid, a 20-oxo steroid, a 21-hydroxy steroid, a 3-oxo-Delta(4) steroid, a glucocorticoid, a 17alpha-hydroxy steroid, a 16alpha-hydroxy steroid, a C21-steroid hormone, a primary alpha-hydroxy ketone and a tertiary alpha-hydroxy ketone. It derives from a hydride of a pregnane.
Classification	Small molecule
Drug class	steroids (not prednisolone derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	C[C@]12C[C@H](O)[C@@]3(F)[C@@H](CCC4=CC(=O)C=C[C@@]43C)[C@@H]1C[C@@H](O)[C@]2(O)C(=O)CO

Identifiers

PDB	—
CAS-ID	124-94-7
RxCUI	10759
ChEMBL ID	CHEMBL1451
ChEBI ID	9667
PubChem CID	31307
DrugBank	DB00620
UNII ID	1ZK20VI6TY (ChemIDplus, GSRS)

Target

Agency Approved

NR3C1

Organism

Homo sapiens

Gene name

NR3C1

Gene synonyms

GRL

NCBI Gene ID

2908

Protein name

glucocorticoid receptor

Protein synonyms

Nuclear receptor subfamily 3 group C member 1, nuclear receptor subfamily 3 group C member 1 variant hGR-B(54), nuclear receptor subfamily 3 group C member 1 variant hGR-B(77), nuclear receptor subfamily 3 group C member 1 variant hGR-B(93), nuclear receptor subfamily 3, group C, member 1 (glucocorticoid receptor)

Uniprot ID

Q6N0A4

Mouse ortholog

Nr3c1 (14815)

glucocorticoid receptor (Q61629)

Alternate

No data

Variants

Clinical Variant

No data

Financial

Zilretta - Flexion Therapeutics

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Zilretta - Pacira BioSciences

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Safety

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Adverse Events

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18,098 adverse events reported

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