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Data updated: May 26, 2026

KENALOG-80 (triamcinolone acetonide)

Corticosteroid Hormone Receptor Agonists
Dermatology Approved 1965-02-01

KENALOG-80 is indicated for the treatment of Dermatoses.

Source: FDA Label • APOTHECON
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
61
Years on Market

Details

Status
Prescription
First Approved
1965-02-01
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

APOTHECON
Active Ingredient: TRIAMCINOLONE ACETONIDE

KENALOG-80 Approval History

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Original
New Indication
New Form
Label Update
30 FDA actions from 1965 to 2024
Aug 2024 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label
Jun 2024 SUPPL
Label · Labeling
FDA Letter Label
Apr 2019 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label

What KENALOG-80 Treats

1 indications

KENALOG-80 is approved for 1 conditions since its original approval in 1965. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Dermatoses
Source: FDA Label

KENALOG-80 Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

HALOBETASOL PROPIONATE AND TAZAROTENE
SUN PHARMA
2025 1 indic.
CLOCORTOLONE PIVALATE
TARO
2020 1 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to KENALOG-80

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ALA-SCALP
HYDROCORTISONE
1 shared
LEGACY PHARMA
Shared indications:
Dermatoses
ALCLOMETASONE DIPROPIONATE
ALCLOMETASONE DIPROPIONATE
1 shared
SUN PHARMA CANADA
Shared indications:
Dermatoses
AMCINONIDE
AMCINONIDE
1 shared
TARO PHARM INDS
Shared indications:
Dermatoses
View all 20 similar drugs Pro
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Clinical Trial Registry

58 trials
Trial Sponsor ID Phase Status Title
NCT04207931 CCCA IRB00043796 Ph 4 recruiting Treatment Results for Patients With Central Centrifugal Cicatricial Alopecia (CCCA): a Multicenter Prospective Study
NCT07453238 CALISTA-AA AA-RCT-2026-01 Ph 4 not yet recruiting Comparison of Topical Calcipotriol and Intralesional Steroids in Alopecia Areata
NCT05436535 LEADS DAIT ADRN-12 Ph 4 completed Longitudinal Endotyping Of Atopic Dermatitis Through Transcriptomic Skin Analysis
NCT04002362 results posted IRB00111087 R01NR018666 Ph 2 completed Symptom Clusters in Children With Exacerbation-prone Asthma
NCT06401317 CASITOA CASITOA Ph 2 recruiting Corticosteroid Against Saline Injections for Thumb Osteoarthritis (CASITOA)
NCT06977568 006-C-202 Ph 2 terminated A Study to Evaluate an Intra-Articular Injection of ZILRETTA Versus Triamcinolone Acetonide, Immediate Release in Subjects With Osteoarthritis of the Hip
NCT05190770 results posted 21-091 Ph 2 completed A Study of Oleogel-S10 Gel for the Treatment of Radiation Dermatitis in People With Breast Cancer
NCT05535738 STUDY00000321 Ph 2, Ph 3 active not recruiting Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation
NCT07189572 UHCT250873 Ph 3 not yet recruiting Intranasal Corticosteroid Spray for Preventing Otitis Media With Effusion After Radiotherapy in Nasopharyngeal Carcinoma
NCT07141446 GDCH/IEC/I-2024(04) Ph 1, Ph 2 completed Evaluation of Efficacy of Neem (Azadirachta Indica) Versus Triamcinolone Acetonide in the Treatment of Oral Lichen Planus.
NCT07114016 FDASU-REC0787 Ph 4 completed Efficacy of Topical Glucosamine Versus Corticosteroid in Oral Lichen Planus
NCT04469075 19-342 Ph 2 active not recruiting Clindamycin and Triamcinolone in People With Glioblastoma to Prevent Skin-Related Side Effects of Tumor Treating Fields
NCT07100145 FDASU-Rec IM012414 Ph 4 not yet recruiting Efficacy of Coconut Gel Compared to Corticosteroid Gel in the Management of Oral Lichen Planus
NCT07014280 BevaVSsteroid:keloids Ph 4 active not recruiting Bevacizumab Versus Triamcinolone Acetonide for the Treatment of Keloids.
NCT04731233 results posted IRB202000689-A OCR40106 Ph 4 terminated Efficacy of PRGF Supplementation After TMJ Arthrocentesis in Patients With TMJ Osteoarthritis
NCT06814288 DV-202501.01 Ph 2 active not recruiting The Effectiveness of Intralesional Botulinum Toxin A and Triamcinolone Acetonide Injections in Keloid Treatment
NCT06810752 24-092 Ph 1, Ph 2 enrolling by invitation Thyme Honey for Management of Oral Lichen Planus
NCT05806021 21.411 Ph 4 recruiting The Efficacy of Intra-articular Triamcinolone Acetonide 5mg vs. 10 mg vs. 40 mg in Patients With Knee Osteoarthritis
NCT05512962 CAPE results posted OXUCT-103 - CAPE 2022-001533-37 Ph 2 completed Oxulumis® Suprachoroidal Microcatherization of Triesence® in Diabetic Macular Edema
NCT05158699 EPICAT NL72427.068.19 2019-004890-21 Ph 3 terminated Effectiveness of Periocular Drug Injection in CATaract Surgery
NCT06524323 2024-0042 Ph 3 not yet recruiting A Randomized, Double-blinded, Self-controlled Clinical Study of Intralesional Injection of 5-fluorouracil Plus Triamcinolone for the Treatment of Refractory Nodular Prurigo
NCT03166761 results posted SCHNEIBJ03152017153735 Ph 4 terminated Particulate Corticosteroid Versus Non-particulate Corticosteroid for Sacroiliac Joint Injection
NCT04075136 IRB00058375 Ph 4 withdrawn Optical Coherence Tomography Angiography (OCTA) - Directed PDT Triple Therapy
NCT03636373 results posted Pro2018000562 Ph 4 terminated Pilot Study Evaluating The Efficacy Of Etanercept In Acute Gout
NCT05413330 UDMS-Opthal-01-2022 Ph 2, Ph 3 completed Corticosteroid Injection Combined With Cataract Surgery in Diabetic Eyes.
NCT03293368 PRP-olp Ph 2 completed Efficacy of Intralesional Injection of Platelet Rich Plasma in the Treatment of Patients With Erosive Oral Lichen Planus
NCT03382925 results posted 106288 Ph 4 terminated Does Low-does Cervical Epidural Lidocaine Cause Transient Weakness?
NCT05429450 TOMATO MD-139-2020 Ph 2 completed Thyroid Associated Orbitopathy Treatment by Methotrexate Against Triamcinolone Periocular Injections
NCT03627741 17-008766 Ph 1 completed A Pilot Study of Intralesional Injection of Triamcinolone Acetonide for Desmoid Tumors
NCT03248856 1456/2017 2017-002377-19 Ph 1 completed Triamcinolone Levels in Cochlear Perilymph
NCT02873026 ASCOT CHAD1031 Ph 3 completed Adjunctive Steroid Combination in Ocular Trauma (ASCOT) Study
NCT04976673 kb256/2020 Ph 2 completed Comparison of Clinical Efficiency of Photodynamic Therapy and Topical Corticosteroid in Treatment of Oral Lichen Planus
NCT01572350 ALBA ALBA09 Ph 3 completed Safety and Efficacy of Triamcinolone Acetonide Combined With Laser, Bevacizumab Combined With Laser Versus Laser Alone for the Treatment of Diffuse Non-tractional Diabetic Macular Edema
NCT02877485 results posted IRB-36535 Ph 4 completed The Effectiveness of Nasal Corticosteroids Versus Placebo in Nasal Obstruction in Patients With Nasal Septal Deviation
NCT02025023 CTS STUDY00003748 Ph 3 recruiting Local 5-Fluorouracil Injection for the Treatment of Chalazia: A Prospective, Comparative Study
NCT02221453 PersDMEcytokineTA Ph 2 completed Cytokine Levels in Patients With Persistent Diabetic Macular Edema Treated With Triamcinolone Acetonide
NCT02120261 USAMPS results posted HSC-MS-14-0072 Ph 4 terminated Using Saline for Myofascial Pain Syndromes (USAMPS)
NCT03319784 STUDY00008014 Ph 4 withdrawn Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients
NCT02598869 00011584 Ph 4 withdrawn Posterior Subtenon Versus Intravitreal Injection of Triamcinolone Acetonide for Treatment of Uveitic Cystoid Macular Edema
NCT02294656 ML27905 Ph 1 completed Acute Pseudophakic Cystoid Macular Edema Treatment Trial: Intravitreal Ranibizumab Versus Triamcinolone Acetonide
NCT03535233 AA22 Ph 4 completed Topical 5% Minoxidil and Potent Topical Corticosteroid Versus Intralesional Corticosteroid in the Treatment of Alopecia Areata
NCT03120923 HE551338 Ph 4 completed Combined Corticosteroid With Low Volume Compared to High Volume in Impingement Syndrome
NCT01230424 results posted NIH NIAMS R01-AR057802 Tufts MC IRB Protocol # 9417 Ph 4 completed Effect of Steroid Injections in a Knee With Osteoarthritis
NCT01362608 results posted CACZ885H2358 2010-024172-26 Ph 3 terminated Safety & Efficacy of Canakinumab (ACZ885) in Patients With Frequent Flares for Whom Nonsterodial Anti-Inflammatory Drug (NSAIDs) and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective
NCT01978301 117287 Ph 1 terminated Study to Evaluate Fractional Collagen Synthesis Within Keloid Scars and Identify Biomarkers of Keloid Scars
NCT01774474 PREMED NL42463.068.12 Ph 3 completed PRevention of Macular EDema After Cataract Surgery
NCT02828163 PRP # steroids in pemphigus Ph 3 completed Comparison Between Injections of Steroids and Autologous Platelet Rich Plasma in the Oral Erosions of Pemphigus Vulgaris
NCT02329600 results posted polyphenol_TOC_OLP Ph 3 completed Evaluation of Green Tea as Antioxidant Agent in Management of Oral Lichen Planus
NCT02022930 COR1.1 Ph 3 completed Hydros and Hydros-TA Joint Therapy for Pain Associated With Knee Osteoarthritis
NCT02858297 FDASU-RECD 1214403 Ph 4 completed Glucosamine as a Novel Adjunctive Therapy in Oral Lichen Planus

Showing 50 of 58 trials

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Key Completed Trials

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Trial Timeline

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Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

KENALOG-80 FDA Label Details

Indications & Usage

FDA Label (PDF)

KENALOG-80 is indicated for the treatment of Dermatoses.

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Data Sources

FDA Approval: NDA014901 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.