CLINICAL TRIALS PROFILE FOR KENALOG-10

505(b)(2) Clinical Trials for KENALOG-10

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-10

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).
NCT00140803 ↗	Study Of Combined VISUDYNE Therapy With Kenalog In CNV Secondary To Age-Related Macular Degeneration	Completed	Novartis	Phase 2	2003-10-01	To determine whether VISUDYNE therapy in combination with 4 mg intravitreal triamcinolone will reduce the average loss from baseline of best corrected visual acuity (BCVA) as compared with Visudyne therapy without intravitreal triamcinolone at 12 months in subjects with occult subfoveal and minimally classic subfoveal CNV secondary to AMD. The intravitreal triamcinolone will be given as either a 1 mg or 4 mg dose. This study will also evaluate the safety of Visudyne therapy in combination with intravitreal triamcinolone. An interim statistical readout will be performed when the first 60 patients have completed 6 months of follow-up evaluation.

Clinical Trial Conditions for KENALOG-10

Condition Name

Condition Name for KENALOG-10
Intervention	Trials
Shoulder Pain	4
Retinal Vein Occlusion	4
Diabetic Macular Edema	4
Knee Osteoarthritis	3

Condition MeSH

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

Clinical Trial Locations for KENALOG-10

Trials by Country

Trials by Country for KENALOG-10
Location	Trials
United States	130
Canada	9
China	2
United Kingdom	2
Mexico	2

Trials by US State

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

Clinical Trial Progress for KENALOG-10

Clinical Trial Phase

Clinical Trial Phase for KENALOG-10
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	1
PHASE1	1

Clinical Trial Status

Clinical Trial Status for KENALOG-10
Clinical Trial Phase	Trials
Completed	33
RECRUITING	13
Terminated	9

Clinical Trial Sponsors for KENALOG-10

Sponsor Name

Sponsor Name for KENALOG-10
Sponsor	Trials
National Eye Institute (NEI)	6
Flexion Therapeutics, Inc.	3
Milton S. Hershey Medical Center	3

Sponsor Type

Sponsor Type for KENALOG-10
Sponsor	Trials
Other	93
Industry	18
NIH	8

Last updated: May 25, 2026

Kenalog-10 (triamcinolone acetonide) clinical trials update, market analysis, and exclusivity outlook

Executive summary: Kenalog-10 is a brand of triamcinolone acetonide (injectable corticosteroid; 10 mg/mL strength). The drug’s clinical-trials footprint is primarily dominated by older, legacy studies and broad guideline-driven indications for intra-articular, intramuscular, and other corticosteroid uses. From an IP and market perspective, Kenalog-10 faces generic and biosimilar-style small-molecule competition risk from the outset because triamcinolone acetonide is a long-established small molecule and has widespread generic availability in multiple corticosteroid injection formats. Near-term commercialization upside is therefore driven less by “newness” in clinical development and more by formulation-specific product differentiation, channel access, contracting, and supply reliability.

No credible, decision-grade clinical-trials “update” can be produced here without a specific clinical-trials identifier set (study registry IDs, study dates, endpoints, and trial sponsor/manufacturer mapping) tied to Kenalog-10 specifically rather than triamcinolone acetonide broadly.

What is Kenalog-10 and what indications drive use?

Kenalog-10 is an injectable formulation of triamcinolone acetonide at 10 mg/mL. Triamcinolone acetonide is a corticosteroid used across inflammatory and allergic conditions, with common product usage patterns centered on:

• Intra-articular corticosteroid therapy for inflammatory joint disease (e.g., osteoarthritis flares, other arthritides per clinician protocols)
• Intramuscular corticosteroid therapy for select systemic inflammatory states per prescribing practice
• Off-label and labeled uses that vary by region and package labeling

Commercial implication: In most markets, “brand vs generic” outcomes for injectable triamcinolone acetonide typically track tender pricing, reimbursement rules, and stocking preferences more than new clinical differentiation, since active ingredient and pharmacology are widely available.

Kenalog-10 dosage forms and administration

Kenalog-10 is marketed as an injectable suspension. Key commercial and clinical friction points include:

• Needle access and injection volumes driven by concentration (10 mg/mL)
• Site-of-injection technique variability (intra-articular vs intramuscular)
• Batch-to-batch quality and suspension characteristics, which can affect prescriber and facility confidence

What clinical trials include Kenalog-10 specifically, and what is the latest update?

No usable “latest update” can be provided for Kenalog-10 without publishing a study-level record set that confirms the drug product (Kenalog-10 or equivalent 10 mg/mL triamcinolone acetonide suspension) and provides:

• trial registry IDs
• start/completion dates
• endpoints (pain, efficacy scores, flare frequency)
• sponsor and geographies
• publication dates and statistical results

Without that, any “clinical trials update” would risk collapsing Kenalog-10 into triamcinolone acetonide broadly, which is not decision-grade for a branded product assessment.

How does Kenalog-10 market performance compare with other injectable triamcinolone brands and generics?

Featured-snippet answer: Kenalog-10 competes primarily with generic triamcinolone acetonide injectable suspensions and other corticosteroid injection offerings on price and formulary inclusion, not on unique mechanism-of-action.

Typical competitive basis for corticosteroid injections

• Acquisition cost per injection
• Facility contracting and group purchasing organization terms
• Formulary step edits for corticosteroids
• Substitution rules under pharmacy and therapeutics policies
• Supply continuity and lot availability

What matters for product-level share

For a legacy corticosteroid suspension brand, market share tends to respond to:

• changes in wholesale acquisition cost
• payer and provider reimbursement framing
• shortages and distribution stability
• switching costs for clinics and ambulatory surgery centers

What is the exclusivity timeline for Kenalog-10 and when do patents expire?

Decision-grade exclusivity timelines require a confirmed Orange Book or equivalent patent listing set tied to Kenalog-10’s specific NDA/NDC entries. Without a product-accurate listing set, providing “when exclusivity expires” would be speculative and not suitable for licensing, litigation, or investment decisions.

What patents protect Kenalog-10 and how many are still enforceable?

No patent estate count or enforceability assessment can be produced without:

• the exact branded product identifier (NDA, supplement numbers where relevant)
• Orange Book patent list extraction (US) and/or jurisdictional equivalents
• current status (expired, withdrawn, cancelled, expired-by-time, or terminally disclaimed terms)

Without that, any number of patents “covering Kenalog-10” would mix triamcinolone acetonide generics and unrelated corticosteroid injections.

Is Kenalog-10 at risk from Paragraph IV challenges or generic entry?

For legacy small-molecule corticosteroids, generic entry risk is generally high as active ingredient patents are long past their typical lifecycles. But a Paragraph IV risk call for Kenalog-10 requires:

• Orange Book patent list mapping to identify which patents (if any) are still listed for the Kenalog-10 NDA/NDC
• whether the relevant patent(s) are still enforceable and what the generic filer could target

Without that mapping, a “Paragraph IV likelihood” assessment would not meet a litigation-grade standard.

What generic entry scenarios could impact Kenalog-10 revenue projection?

Revenue-impact scenarios for a legacy injectable corticosteroid brand usually follow three patterns:

1. Direct price erosion from additional generic supply
2. Formulary exclusion if a lower-cost alternative reaches preferred status
3. Contract loss driven by tender price caps

Key driver: Whether Kenalog-10 remains contractually protected in key provider segments (orthopedics, rheumatology clinics, pain management, ambulatory surgery) or is treated as a freely substitutable item.

How does Kenalog-10 compare with competitor intra-articular corticosteroid injections?

Even within injectable corticosteroids, substitution often occurs across classes:

• triamcinolone acetonide vs other steroid injections (e.g., methylprednisolone derivatives, betamethasone formulations)
• different crystal suspensions and dosing schedules that can change administration frequency
• region-specific availability and reimbursement

Net effect: Kenalog-10’s competitive positioning is primarily commercial and supply-driven. Clinical head-to-head superiority claims are uncommon for legacy triamcinolone suspensions because comparative advantage is usually small and depends on clinician preference.

What is the FDA regulatory status of Kenalog-10?

A precise “FDA regulatory status” requires the specific Kenalog-10 product record, including:

• NDA number
• marketing status
• applicable labeling highlights
• whether any AB-rated generics exist for the specific dosage form/strength

Without a product identifier extract, the regulatory section would be guesswork rather than an actionable status check.

What does the market forecast look like for Kenalog-10?

Decision-grade forecasting requires at least one of the following: country-level sales history for Kenalog-10 (by NDC or brand), payer mix, and competitor share, or a market research dataset anchored to the branded product. None is provided, and no product-accurate identifier is included to allow reliable retrieval.

Given the product’s nature as a legacy corticosteroid injectable, projections in practice are usually constrained by:

• maturity and generic penetration
• limited patent-led growth pathways
• channel-driven unit share volatility rather than new indication expansion

Revenue projection framework for Kenalog-10 (what drives upside/downside)

A practical projection for a legacy branded injectable like Kenalog-10 typically models:

• Unit demand stability: depends on chronic inflammatory management patterns and switching behavior
• Net price: depends on tendering and rebate dynamics
• Share: depends on formulary placement and distribution availability
• Supply constraints: can temporarily lift share and pricing
• Portfolio substitution: competition from alternative steroid injections and other long-acting formulations

Key Takeaways

• Kenalog-10 is a triamcinolone acetonide 10 mg/mL injectable corticosteroid, and its market dynamics are dominated by generic substitution and contracting, not by new clinical differentiation.
• A clinical trials update specific to Kenalog-10 cannot be provided here without trial-level records tied to the exact product.
• Exclusivity, Orange Book status, and patent-driven entry timing also cannot be produced without a product-accurate listing set tied to Kenalog-10’s NDA/NDC.
• Near-term business outcomes are most likely to be driven by pricing, formulary contracting, and supply, rather than by a patent-backed exclusivity ramp.

FAQs

1. What NDC/NDA is Kenalog-10 listed under, and which generics are AB-rated to it?
2. Do any ongoing trials evaluate triamcinolone acetonide 10 mg/mL suspension for new indications under the Kenalog brand?
3. What are the main drivers of formulary inclusion for injectable triamcinolone products in orthopedics and rheumatology clinics?
4. How do supply shortages in triamcinolone acetonide injections affect brand unit share and realized net price?
5. Which competitor steroid injections most frequently substitute for Kenalog-10 in intra-articular and intramuscular use?

References

1. No sources were provided or cited because a product-accurate Kenalog-10 record set (FDA/Orange Book, registries, filings, litigation) is not available in the input.