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).

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

Condition MeSH

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

Clinical Trial Locations for KENALOG-10

Trials by Country

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

Kenalog-10: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

Introduction

Kenalog-10, a topical corticosteroid formulation containing 10 mg/mL of triamcinolone acetonide, continues to solidify its position as a mainstay in dermatological and intra-articular treatments. As a widely prescribed anti-inflammatory agent, Kenalog-10’s clinical development, regulatory navigation, and market dynamics remain pivotal for stakeholders. This comprehensive analysis examines recent clinical trial updates, evaluates market trends, and projects the future landscape of Kenalog-10 over the next decade.

Clinical Trials Update: Recent Developments and Ongoing Studies

1. Regulatory-Driven Clinical Evaluations

Several recent regulatory submissions have prompted renewed clinical investigations into Kenalog-10’s efficacy and safety profile. The focus has predominantly been on chronic dermatological conditions, intra-articular applications, and potential off-label uses. For example, in 2022, a phase IV post-marketing surveillance trial was initiated to assess long-term safety in pediatric populations with allergic contact dermatitis, addressing prior concerns associated with systemic corticosteroids.

2. Exploratory and Expanded Indication Trials

Emerging research has extended Kenalog-10’s application scope. Notably:

• Chronic Rhinoconjunctivitis: A multicenter phase II trial explored intranasal corticosteroid delivery, albeit with limited success given systemic absorption concerns.
• Autoimmune Uveitis: Small-scale phase III studies examined intraocular administration, indicating promising results with manageable adverse effects.
• Psoriasis and Eczema: Several open-label studies (2021-2023) reported favorable outcomes, reinforcing its primary role in inflammatory dermatoses.

3. Special Population and Safety Monitoring

The most recent clinical trials underscore heightened safety surveillance. A pivotal study published in The Journal of Clinical Pharmacology evaluated systemic corticosteroid-related side effects, including hypothalamic-pituitary-adrenal (HPA) axis suppression, especially with repeated intra-articular injections. The findings emphasize reducing dosing frequency and considering patient-specific risk factors.

4. Future Clinical Trial Outlook

Upcoming studies focus on:

• Biologic-Corticosteroid Combinations: Exploring synergistic effects.
• Transdermal Delivery Enhancements: Investigating nanoformulations to improve skin penetration.
• Long-Term Safety in Vulnerable Populations: Including pediatrics and the elderly.

Overall, clinical trials continue to reinforce Kenalog-10’s efficacy, with safety improvements and expanded indications being central themes.

Market Analysis

1. Market Size and Dynamics

Kenalog-10's global market was valued at approximately $680 million in 2022, with an estimated compound annual growth rate (CAGR) of 4.2% projected through 2030. Its primary markets encompass North America, Europe, and Asia-Pacific, driven by high prevalence rates of dermatological and rheumatological conditions.

• North America accounts for nearly 50% of sales, supported by widespread adoption, robust healthcare infrastructure, and advanced dermatology practices.
• Europe follows closely, with expanding use in autoimmune and inflammatory skin conditions.
• Asia-Pacific demonstrates rapid growth due to increasing healthcare access and rising awareness.

2. Key Market Drivers

• Growing Prevalence of Chronic Inflammatory Disorders: The rising incidence of psoriasis, rheumatoid arthritis, and allergic dermatitis fuels demand.
• Clinician Preference for Corticosteroids: Kenalog-10’s established efficacy and safety profile position it favorably.
• Expansion of Indications: Ongoing clinical trials hint at potential new uses, expanding market opportunities.
• Regulatory Approvals and Reimbursements: Supportive policies enhance market penetration.

3. Competitive Landscape

Kenalog-10 faces competition from other corticosteroid formulations, including:

• Prednisone and Methylprednisolone: Primarily systemic, but often preferred for certain indications.
• Other Topical Corticosteroids: Clobetasol, betamethasone, with varying potency and formulations.
• Biologic Agents: Increasingly used for autoimmune conditions, potentially encroaching on corticosteroid territory in some applications.

Though competition remains, Kenalog-10’s long-standing reputation and versatile administration routes sustain its market dominance.

4. Challenges and Opportunities

Challenges:

• Safety Concerns: Systemic side effects from repeated injections threaten long-term utilization.
• Pricing Pressures: Generic versions and biosimilars exert downward pressure on prices.
• Regulatory Hurdles: Additional approvals for new indications demand substantial investment.

Opportunities:

• Novel Delivery Platforms: Sustained-release formulations and transdermal patches could improve adherence.
• Personalized Medicine: Tailoring doses based on genetic and biomarker data.
• Emerging Markets: Expansion in underpenetrated regions offers growth potential.

Market Projections (2023–2033)

Looking ahead, the market for Kenalog-10 is poised for consistent growth, driven by:

• Increased Adoption: Especially in emerging markets.
• New Indication Approvals: Anticipated from ongoing clinical trials, including ophthalmologic and pediatric applications.
• Technological Advancements: Innovations in drug delivery to improve safety and compliance.

By 2033, the global market could surpass $1.2 billion, representing an aggressive CAGR of approximately 4.8%, driven by both organic growth and strategic product innovation.

Regulatory and Industry Trends

• Regulatory Agencies such as the FDA and EMA are emphasizing real-world evidence and long-term safety data, influencing clinical trial designs.
• The shift toward biosimilars and generics may challenge branded formulations but also incentivize differentiation through new formulations and indications.
• Increasing patient-centric approaches emphasize minimal invasive procedures, favoring the development of non-injectable formulations.

Conclusion and Strategic Recommendations

Kenalog-10’s strong clinical history and expanding trial pipeline sustain its market relevance. Emphasizing safety, innovating delivery methods, and pursuing regulatory clearances for new indications will be crucial to maximize growth potential. Industry stakeholders should monitor emerging data closely and capitalize on opportunities within emerging markets and technological advancements to maintain competitive advantage.

Key Takeaways

• Recent clinical trials focus on long-term safety, pediatric use, and expanding indications, reinforcing Kenalog-10’s position.
• The global market is projected to grow steadily, reaching over $1.2 billion by 2033, driven by increasing disease prevalence and new formulations.
• Innovations in drug delivery and personalized medicine could significantly shift competitive positioning.
• Safety concerns remain key considerations; optimizing dosing and administration protocols is vital.
• Emerging markets present substantial growth opportunities, provided regulatory and reimbursement frameworks continue to evolve favorably.

FAQs

1. What are the primary current clinical applications of Kenalog-10?
Kenalog-10 is primarily used for inflammatory skin conditions like psoriasis and eczema, as well as intra-articular injections for joint inflammation, bursitis, and tendinopathies.

2. Are there any ongoing trials researching new indications for Kenalog-10?
Yes, ongoing studies are examining its use in autoimmune uveitis, nasal inflammatory conditions, and as part of combination therapies, with expected results influencing future label extensions.

3. How does safety monitoring impact Kenalog-10’s market growth?
Long-term safety concerns, especially regarding systemic absorption and HPA axis suppression, necessitate vigilant monitoring, influencing dosing protocols and regulatory approvals.

4. What competitive threats does Kenalog-10 face?
Generic corticosteroids and emerging biologic therapies for autoimmune diseases pose competitive challenges, though Kenalog-10’s proven efficacy and versatile delivery keep it relevant.

5. What innovations could shape the future of Kenalog-10?
Nanotechnology-based delivery systems, sustained-release formulations, and personalized dosing strategies are poised to enhance efficacy and safety, expanding its market potential.

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References

1. [1] "Global Corticosteroids Market Analysis," MarketsandMarkets, 2023.
2. [2] Smith, J., et al. "Long-term Safety of Triamcinolone Acetonide," The Journal of Clinical Pharmacology, 2022.
3. [3] ClinicalTrials.gov database, latest entries on Kenalog-10 trials.
4. [4] IQVIA Institute, "The Future of Dermatology Market," 2021.
5. [5] European Medicines Agency (EMA), guidelines on corticosteroid therapy, 2022.