CLINICAL TRIALS PROFILE FOR KENALOG

505(b)(2) Clinical Trials for KENALOG

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00071227 ↗	Eye Injections of Triamcinolone Acetonide for Retinal Blood Vessel Disorders	Completed	National Eye Institute (NEI)	Phase 1	2003-10-15	This study will evaluate the safety and effectiveness of a new formulation of triamcinolone acetonide for the treatment of retinal blood vessel disorders. Triamcinolone is a steroid drug that decreases inflammation and scarring and is routinely used to treat eye inflammation or swelling. The commercially available form of this drug is associated with potentially harmful side effects thought to be due to preservatives in the preparation. This study will use a formulation that does not contain these potentially harmful preservatives. Preliminary findings from other studies suggest that injection of steroids in the eye can reduce retinal thickening and improve vision. However, they may also cause mild discomfort and lead to vision-threatening conditions. The effects of the drug on the conditions under study in this protocol are not known. Patients with the following conditions involving disorders of retinal blood vessels may be eligible for this study: - Choroidal neovascularization associated with age-related macular degeneration (50 years of age and older) - Macular edema associated with retinal vein occlusion (18 years of age and older) - Diabetic macular edema ((18 years of age and older) Participants undergo the following tests and procedures: - Medical history and physical examination - Eye examination to assess visual acuity (eye chart test) and eye pressure, and to examine pupils, lens, retina and eye movements. The pupils will be dilated with drops for this examination. - Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina are taken using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible blood vessel abnormality. - Indocyanine green angiography to identify feeder vessels that may be supplying abnormal blood vessels. This procedure is similar to fluorescein angiography, but uses a green dye and flashes an invisible light. - Optical coherence tomography to measure retinal thickness. This test shines a light into the eye and produces cross-sectional pictures of the retina. These measurements are repeated during the study to determine if retinal thickening is getting better or worse, or staying the same. - Stereoscopic color fundus photography to examine the back of the eye. The pupils are dilated with eye drops to allow examination and photography of the back of the eye. - Triamcinolone acetonide injection to treat the eye. A numbing eye drop, an antibiotic eye drop, and an injected antibiotic are put in the eye before triamcinolone acetonide is injected into the eye's vitreous (jelly-like substance inside the eye). After the injection, the patient lies on his or her back for 30 minutes. An antibiotic eye ointment is used for 2 days following treatment. - Blood tests to measure liver and kidney function. Patients return to the clinic for follow-up visits 1, 4, and 7 days, and 1 month after the first treatment. Patients whose condition does not improve after 3 months do not receive any more injections, but return for eye examinations at least once a year for 3 years. Patients whose condition improves with treatment return for follow-up visits 6 and 9 months after the first injection and then every 6 months for 2 more years. At each visit, a determination is made whether another injection is needed. After each repeat injection, patients return for follow-up visits at 1, 4, and 7 days after the injection.

All Clinical Trials for KENALOG

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00071227 ↗	Eye Injections of Triamcinolone Acetonide for Retinal Blood Vessel Disorders	Completed	National Eye Institute (NEI)	Phase 1	2003-10-15	This study will evaluate the safety and effectiveness of a new formulation of triamcinolone acetonide for the treatment of retinal blood vessel disorders. Triamcinolone is a steroid drug that decreases inflammation and scarring and is routinely used to treat eye inflammation or swelling. The commercially available form of this drug is associated with potentially harmful side effects thought to be due to preservatives in the preparation. This study will use a formulation that does not contain these potentially harmful preservatives. Preliminary findings from other studies suggest that injection of steroids in the eye can reduce retinal thickening and improve vision. However, they may also cause mild discomfort and lead to vision-threatening conditions. The effects of the drug on the conditions under study in this protocol are not known. Patients with the following conditions involving disorders of retinal blood vessels may be eligible for this study: - Choroidal neovascularization associated with age-related macular degeneration (50 years of age and older) - Macular edema associated with retinal vein occlusion (18 years of age and older) - Diabetic macular edema ((18 years of age and older) Participants undergo the following tests and procedures: - Medical history and physical examination - Eye examination to assess visual acuity (eye chart test) and eye pressure, and to examine pupils, lens, retina and eye movements. The pupils will be dilated with drops for this examination. - Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina are taken using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible blood vessel abnormality. - Indocyanine green angiography to identify feeder vessels that may be supplying abnormal blood vessels. This procedure is similar to fluorescein angiography, but uses a green dye and flashes an invisible light. - Optical coherence tomography to measure retinal thickness. This test shines a light into the eye and produces cross-sectional pictures of the retina. These measurements are repeated during the study to determine if retinal thickening is getting better or worse, or staying the same. - Stereoscopic color fundus photography to examine the back of the eye. The pupils are dilated with eye drops to allow examination and photography of the back of the eye. - Triamcinolone acetonide injection to treat the eye. A numbing eye drop, an antibiotic eye drop, and an injected antibiotic are put in the eye before triamcinolone acetonide is injected into the eye's vitreous (jelly-like substance inside the eye). After the injection, the patient lies on his or her back for 30 minutes. An antibiotic eye ointment is used for 2 days following treatment. - Blood tests to measure liver and kidney function. Patients return to the clinic for follow-up visits 1, 4, and 7 days, and 1 month after the first treatment. Patients whose condition does not improve after 3 months do not receive any more injections, but return for eye examinations at least once a year for 3 years. Patients whose condition improves with treatment return for follow-up visits 6 and 9 months after the first injection and then every 6 months for 2 more years. At each visit, a determination is made whether another injection is needed. After each repeat injection, patients return for follow-up visits at 1, 4, and 7 days after the injection.
NCT00101764 ↗	Intravitreal v. Sub-tenon Injections of Triamcinolone Acetonide for Macular Edema in Retinal Disorders	Completed	National Eye Institute (NEI)	Phase 1	2005-01-05	The use of intravitreal injections of corticosteroid (triamcinolone acetonide) appears to be a promising treatment for a variety of ocular diseases associated with inflammation. To date, the only drug available, "Kenalog-40 Injection" produced by Bristol Myers Squibb, has not been formulated for intraocular use. The purpose of this study is to evaluate the long-term safety and potential efficacy of novel intravitreal injections of a preservative-free formulation of triamcinolone acetonide (TAC-PF) at two dosage levels (4 mg and 8 mg) compared to anterior sub-tenon injections of TAC-PF at 20 mg. The study will be a masked, randomized Phase I study that will enroll 120 participants with one of the following diseases: age-related macular degeneration (AMD), diabetic macular edema (DME), central retinal vein occlusion (CRVO), branch retinal vein occlusion (BRVO), or any other retinal disease with associated macular edema. At least 21 participants will be enrolled in the four designated disease strata: AMD, DME, CRVO, and BRVO. The remaining 36 participants may have one of these diseases or may be enrolled with another retinal disease. Within each disease strata, at least seven participants will be randomized to each dosing group. The participants will be randomly assigned to one of the three treatment groups. The primary outcome will be an assessment of post-injection intraocular toxicity-related events during the 3-year follow-up, including cataract formation, development of glaucoma, and any adverse event preventing retreatment. The secondary outcomes will be an improvement in best-corrected visual acuity (BCVA, EVA) and decreases in retinal thickening and area of leakage, from baseline to year 1.
NCT00105027 ↗	The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study	Completed	Allergan	Phase 3	2004-10-01	The SCORE Study will compare the effectiveness and safety of standard care to intravitreal injection(s) of triamcinolone for treating macular edema (swelling of the central part of the retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO).
NCT00105027 ↗	The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study	Completed	National Eye Institute (NEI)	Phase 3	2004-10-01	The SCORE Study will compare the effectiveness and safety of standard care to intravitreal injection(s) of triamcinolone for treating macular edema (swelling of the central part of the retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO).
NCT00105027 ↗	The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study	Completed	The Emmes Company, LLC	Phase 3	2004-10-01	The SCORE Study will compare the effectiveness and safety of standard care to intravitreal injection(s) of triamcinolone for treating macular edema (swelling of the central part of the retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO).
NCT00105027 ↗	The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study	Completed	The EMMES Corporation	Phase 3	2004-10-01	The SCORE Study will compare the effectiveness and safety of standard care to intravitreal injection(s) of triamcinolone for treating macular edema (swelling of the central part of the retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO).

Clinical Trial Conditions for KENALOG

Condition Name

Condition Name for KENALOG
Intervention	Trials
Shoulder Pain	4
Retinal Vein Occlusion	4
DIABETIC MACULAR EDEMA	4
Knee Osteoarthritis	3

Condition MeSH

Condition MeSH for KENALOG
Intervention	Trials
Osteoarthritis	10
Macular Edema	10
Osteoarthritis, Knee	9
Edema	8

Clinical Trial Locations for KENALOG

Trials by Country

Trials by Country for KENALOG
Location	Trials
United States	130
Canada	9
Mexico	2
Egypt	2
China	2

Trials by US State

Trials by US State for KENALOG
Location	Trials
California	11
Pennsylvania	10
Texas	7
Florida	7
Utah	6

Clinical Trial Progress for KENALOG

Clinical Trial Phase

Clinical Trial Phase for KENALOG
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	1
PHASE1	1

Clinical Trial Status

Clinical Trial Status for KENALOG
Clinical Trial Phase	Trials
Completed	33
Recruiting	13
Terminated	9

Clinical Trial Sponsors for KENALOG

Sponsor Name

Sponsor Name for KENALOG
Sponsor	Trials
National Eye Institute (NEI)	6
Flexion Therapeutics, Inc.	3
Milton S. Hershey Medical Center	3

Sponsor Type

Sponsor Type for KENALOG
Sponsor	Trials
Other	93
Industry	18
NIH	8

Last updated: April 28, 2026

Kenalog (triamcinolone acetonide): Clinical Trials Update and Market Projection

Kenalog is a branded corticosteroid product containing triamcinolone acetonide (various formulations, including injectable and topical). Public trial activity for “Kenalog” specifically is limited because most development is tied to the active ingredient across multiple brands and product forms rather than the Kenalog brand name in registries. The practical market outlook therefore depends on (1) ongoing demand for intra-articular and peri-articular steroid injections, (2) risk and uptake dynamics of competing depot and non-depot steroids, and (3) payer and guideline preferences for steroid selection.

What is the current clinical-trials footprint for Kenalog?

Public registries do not show a dense set of new, Kenalog-branded interventional trials in recent years. Trial activity is more commonly labeled under triamcinolone acetonide rather than the brand. The most actionable way to interpret “clinical-trials update” for Kenalog is to map evidence to the active ingredient and to the specific route of administration.

Kenalog-relevant trial categories in the public domain

• Intra-articular triamcinolone acetonide studies for osteoarthritis pain and inflammation endpoints (pain scales, responder rates, duration of effect).
• Ophthalmic and other specialty uses where triamcinolone formulations are evaluated for inflammation and macular edema (often using different triamcinolone formats than Kenalog injections).
• Topical triamcinolone acetonide comparative or safety studies (often generic) rather than Kenalog-labeled.

Operational implication for a “Kenalog” brand update

• Near-term, brand-specific clinical development is unlikely to be a primary value driver.
• Most incremental evidence and switching risk come from comparative studies of competing corticosteroid options and from safety updates affecting steroid use in specific indications.

Where does Kenalog face competition in care pathways?

Kenalog competes in steroid-driven pathways where clinicians choose a corticosteroid based on:

• Route and formulation (intra-articular vs peri-articular vs topical)
• Duration of effect and injection schedule frequency
• Local safety profile (for example, infection risk mitigation, glycemic effects, ocular risk where relevant)
• Relative efficacy and tolerability versus alternatives

Core competitor set (in the same therapeutic class and similar use patterns)

• Other intra-articular depot corticosteroids and non-depot options (active ingredients often include triamcinolone variants and alternatives used in injections).
• Hyaluronic acid for osteoarthritis in some pathways, where payers steer after steroid trials or when injection intervals and patient risk profile drive selection.
• Non-steroidal anti-inflammatory drug regimens and physical therapy as upstream substitutes.

How is the market size and growth outlook shaped for Kenalog?

Kenalog is a mature product with broad clinical use. Market growth is driven less by brand-new indications and more by:

• Aging populations and osteoarthritis prevalence
• Physician injection volumes
• Payer reimbursement conditions and formulary placement
• Substitution among corticosteroids and competition from other injectable depots

Because Kenalog is widely available and often substituted with generics (same active ingredient), the brand’s revenue trajectory tends to track:

• Total corticosteroid injection volumes in target specialties
• Share shifts caused by payers and channel strategies
• Wholesale pricing and contract dynamics

Market projection framework (what to model for a Kenalog business case)

A robust projection model for Kenalog should separate revenue into:

1. Unit volumes by route/formulation (injection vs topical)
2. Net price after rebates and discounts (brand vs generic competition)
3. Share displacement from competing depots and alternatives
4. Indication-level demand (osteoarthritis, inflammatory dermatoses, other specialty uses)

Demand anchors

• Osteoarthritis and chronic inflammatory conditions are the primary steady-state volume sources for injectable and topical corticosteroids.
• Injection cadence and guideline adherence determine how “stickiness” plays out against competing products.

Base-case projection logic (directional, decision-ready)

• Volumes: expected to be stable to mildly growing in most markets as chronic disease prevalence increases and as procedure-based management remains standard.
• Net price and brand share: expected to face ongoing downward pressure from generics and formulary competition, making growth dependent on maintaining channel share and limiting displacement.
• Revenue: likely tracks modest growth in units but with flattish-to-downward net price versus historical periods, leading to a conservative net revenue outlook.

What regulatory and safety dynamics affect Kenalog uptake?

Corticosteroid injections and topical corticosteroids face recurring compliance and safety considerations:

• Infection risk around injection sites and strict aseptic technique requirements
• Steroid systemic effects (for example, glycemic impact in susceptible patients)
• Contraindications and warnings for use in specific populations and conditions
• Risk management expectations in product labeling and clinician guidance

These dynamics typically affect:

• Switching behavior between steroid options
• Payer coverage decisions in higher-risk populations
• Monitoring requirements in care pathways

What is the most likely near-term value driver: new trials or market share?

For Kenalog, near-term value is more likely driven by market execution than by new brand-defining clinical trial outcomes:

• Generic pressure limits price upside from new evidence unless it changes formularies or clinical guidelines.
• Competitive landscapes in injection and topical steroid classes usually reward consistent supply, payer coverage, and contracting discipline.

Comparable product evidence: what the broader triamcinolone data implies

While “Kenalog” is a brand, the clinical utility evidence for triamcinolone acetonide informs:

• Expected duration of symptom relief in osteoarthritis and inflammatory joint disease
• Injection response rates and typical follow-up intervals
• Safety profiling used by clinicians in steroid selection

For business planning, the actionable interpretation is:

• Kenalog should be modeled as a mature corticosteroid offering where clinical evidence supports consistent use, but competitive substitution determines revenue.

Market projection: revenue scenario structure for planning

Below is a scenario structure that aligns with how mature branded corticosteroids typically perform in formulary and procurement systems. Use it to drive investment-grade planning around unit volumes, net pricing, and share.

Three-scenario model structure (for Kenalog brand revenue)

Scenario	Unit volume growth	Brand net price trend	Share movement vs generics/competitors	Implied revenue direction
Downside	Flat to -2% CAGR	-2% to -5% CAGR	Share loss	Revenue decline
Base case	0% to 2% CAGR	-1% to -3% CAGR	Stable to slight erosion	Revenue flat to modest decline
Upside	2% to 4% CAGR	-0% to -2% CAGR	Share stabilization/partial gains	Revenue flat to modest growth

This scenario structure should be applied at minimum by route (injectable vs topical) since substitution dynamics differ.

What do investors and R&D leaders watch next for Kenalog?

Key watch items that can move Kenalog market share without needing a brand-new trial portfolio:

• Formulary changes in major payer and PBM channels
• Contracting outcomes in hospital systems for injection kits and buy-and-bill dynamics
• Safety communications impacting steroid injection practice patterns
• Pipeline competition from depot steroids and alternative non-steroid regimens in osteoarthritis and inflammatory conditions

Clinical trial signals that would matter if they appear

If brand-labeled or trial-labeled signals do emerge, the decision-relevant ones are:

• Comparative efficacy studies against specific competing depots that show longer symptom control or better responder rates
• Safety differentiation that meaningfully changes monitoring or contraindication thresholds
• Studies in payer-relevant settings with endpoints aligned to utilization decisions (for example, time to rescue therapy, procedure frequency reduction)

Key Takeaways

• Kenalog is a mature triamcinolone acetonide product where trial activity is not typically brand-defining; decision-making is more influenced by the active ingredient evidence and by competitive substitution.
• The market outlook depends on unit volumes in injection and topical steroid care pathways, tempered by net price pressure from generics and ongoing competition from alternative steroid depots and non-steroid options.
• For planning, use a scenario model that ties revenue to unit volume trends, net pricing erosion, and brand share versus generics and competing products.
• Near-term value is more likely driven by formulary and contracting execution than by new Kenalog-branded clinical outcomes.

FAQs

1) Is Kenalog’s clinical pipeline likely to drive growth in the next few years?

Brand-labeled Kenalog trials are not typically a major growth driver for mature corticosteroids; revenue usually tracks volumes and share under payer and generic pressure.

2) Which indications drive most Kenalog demand?

Injectable and topical corticosteroid demand is primarily anchored in chronic inflammatory and musculoskeletal conditions, with osteoarthritis as a key volume pool for injections.

3) How does generic substitution affect Kenalog’s brand outlook?

Generic triamcinolone acetonide availability usually creates sustained net price pressure and reduces brand share unless Kenalog maintains formulary placement and supply contracts.

4) What competition matters most for Kenalog?

Competition comes from other depot and non-depot corticosteroids, plus non-steroid injection options like hyaluronic acid in some osteoarthritis pathways.

5) What would change the market projection most quickly?

Formulary decisions, PBM contracting outcomes, hospital buy-and-bill dynamics, and safety communications that alter steroid injection utilization patterns.

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References

[1] FDA. Drug Approval Package and labeling resources for triamcinolone acetonide products (including Kenalog-labeled information). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] ClinicalTrials.gov. Search results for “triamcinolone acetonide” and related terms (routes and indications). U.S. National Library of Medicine. https://clinicaltrials.gov/