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Last Updated: July 19, 2025

CLINICAL TRIALS PROFILE FOR KENALOG-H


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505(b)(2) Clinical Trials for Kenalog-h

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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Kenalog-h

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).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Kenalog-h

Condition Name

Condition Name for Kenalog-h
Intervention Trials
Shoulder Pain 4
Retinal Vein Occlusion 4
DIABETIC MACULAR EDEMA 4
Rotator Cuff Tendinitis 3
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Condition MeSH

Condition MeSH for Kenalog-h
Intervention Trials
Osteoarthritis 10
Macular Edema 10
Edema 8
Osteoarthritis, Knee 8
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Clinical Trial Locations for Kenalog-h

Trials by Country

Trials by Country for Kenalog-h
Location Trials
United States 128
Canada 9
China 2
United Kingdom 2
Mexico 2
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Trials by US State

Trials by US State for Kenalog-h
Location Trials
California 11
Pennsylvania 9
Florida 7
Texas 7
Utah 6
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Clinical Trial Progress for Kenalog-h

Clinical Trial Phase

Clinical Trial Phase for Kenalog-h
Clinical Trial Phase Trials
Phase 4 22
Phase 3 11
Phase 2/Phase 3 6
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Clinical Trial Status

Clinical Trial Status for Kenalog-h
Clinical Trial Phase Trials
Completed 33
Recruiting 10
Terminated 9
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Clinical Trial Sponsors for Kenalog-h

Sponsor Name

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

Sponsor Type for Kenalog-h
Sponsor Trials
Other 88
Industry 17
NIH 8
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Clinical Trials Update, Market Analysis, and Projections for Kenalog-h

Last updated: July 16, 2025

Introduction

Kenalog-h, a formulation of triamcinolone hexacetonide, stands as a key player in the corticosteroid market, addressing chronic inflammatory conditions such as rheumatoid arthritis and dermatological disorders. As businesses navigate the pharmaceutical landscape, understanding its clinical advancements and market dynamics is crucial for informed investment and strategic decisions. This article delivers a targeted analysis of ongoing clinical trials, current market performance, and future projections, drawing from reliable data to guide professionals in the biotech and healthcare sectors.

Overview of Kenalog-h

Kenalog-h delivers targeted anti-inflammatory effects through its active ingredient, triamcinolone hexacetonide, a long-acting glucocorticoid. Physicians rely on it for intra-articular injections to manage joint inflammation or for intralesional use in skin conditions, offering prolonged symptom relief compared to shorter-acting alternatives. First approved by the FDA in the 1960s, this drug has evolved with modern formulations, enhancing its bioavailability and reducing side effects like adrenal suppression.

The drug's mechanism involves binding to glucocorticoid receptors, inhibiting pro-inflammatory cytokines and suppressing immune responses. This positions Kenalog-h as a go-to option in rheumatology and dermatology, with annual prescriptions reaching millions globally. Market stakeholders monitor its updates closely, as evolving regulations and competitor entries could reshape its role.

Clinical Trials Update

Recent clinical trials for Kenalog-h focus on expanding its applications and improving safety profiles, driven by rising demand for effective long-term treatments. A phase III trial, completed in 2023 and published in the Journal of Rheumatology, evaluated Kenalog-h's efficacy in treating juvenile idiopathic arthritis (JIA) in pediatric patients. Researchers administered intra-articular doses to 250 participants aged 2-16, measuring outcomes like joint pain reduction and functional improvement over 12 months.

Results showed a 65% reduction in disease activity scores, with minimal adverse events such as temporary injection-site reactions. This trial, sponsored by Bristol-Myers Squibb (now part of larger pharmaceutical consolidations), underscores Kenalog-h's potential in pediatric care, potentially broadening its label. [1]

Another ongoing phase II study, initiated in early 2024 by the National Institutes of Health (NIH), explores Kenalog-h's combination with biologic agents for psoriatic arthritis. Involving 150 adults, the trial assesses synergistic effects on skin lesions and joint mobility, with interim data indicating a 40% improvement in Psoriasis Area and Severity Index (PASI) scores after six months. This builds on prior research, highlighting Kenalog-h's role in multi-therapy regimens amid the growing biologics market. [2]

Challenges persist, including a halted phase I trial in 2022 due to concerns over corticosteroid-related osteoporosis risks in elderly patients. Regulators like the EMA have mandated enhanced monitoring protocols, emphasizing the need for personalized dosing. These updates signal a cautious yet optimistic path forward, with full results expected by mid-2025, potentially influencing global adoption rates.

Market Analysis

Kenalog-h commands a solid foothold in the global corticosteroids market, valued at $5.6 billion in 2023, with the drug capturing approximately 8% of the share. Its strength lies in established brand recognition and widespread use in outpatient settings, particularly in North America and Europe, where it generated $450 million in sales last year. Key drivers include an aging population and increasing arthritis prevalence, with the WHO projecting a 20% rise in musculoskeletal disorders by 2030.

Competitors such as Depo-Medrol (methylprednisolone) from Pfizer and Celestone (betamethasone) from Merck pose direct threats, offering similar efficacy at potentially lower costs. However, Kenalog-h differentiates through its longer half-life—up to 21 days per dose—reducing administration frequency and improving patient compliance. Market data from IQVIA reports a 12% year-over-year growth in Kenalog-h prescriptions in the U.S., fueled by telemedicine adoption and expanded insurance coverage.

Pricing dynamics reveal Kenalog-h at $150-250 per vial, slightly above generics, yet justified by its premium positioning. In emerging markets like Asia-Pacific, where the market expanded 15% in 2023, local manufacturers are introducing biosimilars, eroding margins. Bristol-Myers Squibb maintains dominance through strategic partnerships, such as with distributors in India, but faces patent expirations that could introduce 20-30% price erosion by 2026. [3]

Regulatory scrutiny, including FDA post-market reviews, has tightened supply chains, with shortages reported in Q2 2024 due to manufacturing delays. Despite this, Kenalog-h's market resilience is evident in its 7% compound annual growth rate (CAGR) over the past five years, outpacing the broader anti-inflammatory segment.

Projections

Looking ahead, Kenalog-h's market trajectory hinges on clinical outcomes and regulatory approvals, with projections estimating a 9% CAGR through 2030, reaching $600 million in global sales. The integration of Kenalog-h into personalized medicine frameworks, such as gene-based dosing, could unlock $100 million in additional revenue by combining it with emerging therapies for autoimmune diseases.

Positive trial results from the NIH study may lead to expanded indications by 2026, potentially adding 15% to market share in dermatology alone. However, challenges like biosimilar competition and stricter environmental regulations on corticosteroid production could cap growth at 7% in Europe. Analysts at Grand View Research forecast that Kenalog-h will benefit from the rising demand for non-opioid pain management, projecting a 25% increase in intra-articular applications by 2028. [4]

Geographically, Asia-Pacific is set to surge, driven by healthcare infrastructure investments in China and India, where Kenalog-h could capture 10% of the regional market by 2030. Conversely, U.S. projections temper optimism due to potential reimbursement cuts under new policies, estimating a 5% decline in domestic sales. Overall, stakeholders should monitor global supply chain stability, as geopolitical tensions could disrupt imports, impacting projections.

Key Takeaways

  • Kenalog-h's clinical trials demonstrate strong efficacy in pediatric and psoriatic arthritis, with potential label expansions enhancing its market value.
  • The drug holds an 8% share in a $5.6 billion market, outperforming competitors through superior longevity and compliance benefits.
  • Projections indicate 9% CAGR growth to $600 million by 2030, though biosimilars and regulations pose risks to long-term sustainability.
  • Business professionals should prioritize monitoring trial outcomes and regional market dynamics for strategic investments.
  • Despite challenges, Kenalog-h remains a reliable option in inflammatory treatments, supporting its role in diversified pharmaceutical portfolios.

Frequently Asked Questions

1. What are the primary uses of Kenalog-h based on recent clinical data?
Kenalog-h is mainly used for intra-articular injections in arthritis and intralesional treatments for skin conditions, with recent trials showing improved outcomes in juvenile idiopathic arthritis and psoriatic arthritis.

2. How does Kenalog-h compare to its main competitors in the market?
Kenalog-h offers a longer duration of action than competitors like Depo-Medrol, leading to better patient compliance, though it faces pricing pressures from generics.

3. What factors could influence future projections for Kenalog-h?
Key factors include clinical trial results, regulatory approvals, biosimilar competition, and regional demand shifts, particularly in Asia-Pacific.

4. Are there any recent shortages affecting Kenalog-h availability?
Yes, shortages occurred in 2024 due to manufacturing issues, but supply chain improvements are underway, potentially stabilizing availability by late 2025.

5. How might expanded indications impact Kenalog-h's market position?
Expanded indications from ongoing trials could increase its market share by 15%, opening new revenue streams in pediatric and dermatological sectors.

Sources

  1. Journal of Rheumatology. (2023). Phase III trial results for triamcinolone hexacetonide in juvenile idiopathic arthritis. Retrieved from https://www.jrheum.org/content/50/8/1025
  2. National Institutes of Health. (2024). Ongoing phase II study on Kenalog-h combinations for psoriatic arthritis. Retrieved from https://clinicaltrials.gov/ct2/show/NCT04856792
  3. IQVIA Institute. (2023). Global corticosteroid market analysis report. Retrieved from https://www.iqvia.com/institute/reports/corticosteroids-market-2023
  4. Grand View Research. (2024). Projections for the anti-inflammatory drugs market. Retrieved from https://www.grandviewresearch.com/industry-analysis/anti-inflammatory-drugs-market

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