CLINICAL TRIALS PROFILE FOR KENALOG-40

505(b)(2) Clinical Trials for KENALOG-40

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-40

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-40

Condition Name

Condition Name for KENALOG-40
Intervention	Trials
Shoulder Pain	4
Retinal Vein Occlusion	4
Diabetic Macular Edema	4
Knee Osteoarthritis	3

Condition MeSH

Condition MeSH for KENALOG-40
Intervention	Trials
Osteoarthritis	10
Macular Edema	10
Osteoarthritis, Knee	9
Edema	8

Clinical Trial Locations for KENALOG-40

Trials by Country

Trials by Country for KENALOG-40
Location	Trials
United States	130
Canada	9
Mexico	2
Egypt	2
China	2

Trials by US State

Trials by US State for KENALOG-40
Location	Trials
California	11
Pennsylvania	10
Texas	7
Florida	7
Utah	6

Clinical Trial Progress for KENALOG-40

Clinical Trial Phase

Clinical Trial Phase for KENALOG-40
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	1
PHASE1	1

Clinical Trial Status

Clinical Trial Status for KENALOG-40
Clinical Trial Phase	Trials
Completed	33
Recruiting	13
Terminated	9

Clinical Trial Sponsors for KENALOG-40

Sponsor Name

Sponsor Name for KENALOG-40
Sponsor	Trials
National Eye Institute (NEI)	6
Milton S. Hershey Medical Center	3
Flexion Therapeutics, Inc.	3

Sponsor Type

Sponsor Type for KENALOG-40
Sponsor	Trials
Other	93
Industry	18
NIH	8

Clinical Trials Update, Market Analysis, and Projection for Kenalog-40

Last updated: October 28, 2025

Introduction

Kenalog-40 (triamcinolone acetonide injection, 40 mg/mL) is a corticosteroid utilized primarily for its anti-inflammatory and immunosuppressive properties. Prescribed in conditions such as allergies, dermatologic disorders, and rheumatic diseases, Kenalog-40’s efficacy depends on accurate dosing and administration protocols. Recent developments in clinical trials, market dynamics, and growth projections are integral for pharmaceutical stakeholders to navigate its landscape effectively.

Clinical Trials Update

Overview of Recent Clinical Trials

Over the past three years, clinical research for Kenalog-40 has centered on expanded indications, dosage optimization, and safety profile evaluation. The majority of these trials aim to improve therapeutic outcomes in both adult and pediatric populations.

• Indications Expansion:
  New phase II and III trials explore Kenalog-40's utility in managing conditions like resistant temporomandibular joint disorders and localized hypertrophic scars. A notable trial (NCT04562199) assessed the efficacy of intralesional Kenalog-40 in keloid treatment, demonstrating significant scar regression with minimal adverse effects.

• Safety and Tolerability:
  A multi-center study (NCT04191562) evaluated long-term corticosteroid injections in rheumatoid arthritis patients, confirming the drug's safety profile aligns with existing corticosteroids standards. No new safety concerns emerged, reinforcing its utility in chronic conditions.

• Pharmacokinetic and Pharmacodynamic Studies:
  Trials like NCT04528346 investigated the bioavailability and tissue retention of Kenalog-40 when administered via different injection techniques. These studies aim to refine dosing regimens, minimize systemic absorption, and reduce side effects.

Ongoing and Upcoming Trials

Several trials are in pre-specification or recruitment phases, including:

• Intralesional therapy in dermatologic conditions: A phase IV trial evaluating Kenalog-40 for alopecia areata (NCT05052145).
• Use in pediatric populations: Pediatric safety and efficacy studies for juvenile idiopathic arthritis (NCT05117713) are underway, focusing on dose-specific responses.
• Combination therapies: Exploratory trials assessing Kenalog-40 with other immunomodulators aim to optimize treatment algorithms for autoimmune conditions.

Regulatory and Approval Status

While Kenalog-40 remains FDA-approved for multiple indications, recent trial outcomes could catalyze label expansions or new orphan drug designations, especially if novel therapeutic benefits are demonstrated in resistant or refractory cases. No major regulatory decisions have been announced recently, though submission preparations are ongoing for certain niche indications.

Market Analysis

Current Market Landscape

Kenalog-40’s market shares derive from its longstanding use in dermatology, rheumatology, and allergology. Key players include pharmaceutical giants like Bristol-Myers Squibb and Teva Pharmaceuticals, which manufacture generic formulations. The global corticosteroids market was valued at approximately USD 17.3 billion in 2022 and is projected to grow at a CAGR of around 4.5% through 2030[1].

• Regional Dynamics:
  North America dominates the market, supported by high healthcare expenditure and extensive clinical adoption. Europe follows, with growth driven by rising prevalence of chronic inflammatory diseases. Asia-Pacific shows rapid expansion, fueled by increased healthcare infrastructure and pharmaceutical manufacturing.

• Pricing and Reimbursement:
  The affordability of Kenalog-40, especially as a generic, sustains widespread utilization. Reimbursement policies in major markets facilitate ongoing prescription rates despite the advent of newer biologic agents.

Market Drivers

• Expanding Indications:
  Novel clinical trial results indicating efficacy for skin and joint disorders broaden its application scope, stimulating demand.

• Preference for Local Therapy:
  Intralesional corticosteroids like Kenalog-40 are preferred over systemic therapies in localized inflammatory conditions due to lower systemic side effects.

• Aging Populations:
  The global aging demographic increases prevalence of osteoarthritis, rheumatoid arthritis, and dermatologic conditions amenable to corticosteroid therapy.

Market Challenges

• Side Effect Profile:
  Adverse effects—such as skin atrophy, hypopigmentation, and peri-injection pain—may limit long-term or high-dose usage, influencing prescriber preference.

• Competition:
  Biologic agents and other corticosteroids with improved safety or convenience profiles threaten market share.

• Regulatory Scrutiny:
  Tighter regulations around corticosteroid safety could impact manufacturing and marketing strategies.

Future Market Projections

Given the current trends, the demand for Kenalog-40 is expected to grow modestly, supported by clinical trial expansions, broader indication approval, and regional market penetration. The corticosteroids market is projected to reach USD 24.1 billion by 2030[1], with Kenalog-40 capturing an increasing subset, especially in niche dermatology and rheumatology indications.

Emerging formulations—such as sustained-release variants—may further sustain market engagement. Additionally, integration into multimodal treatment regimens for autoimmune diseases stands to boost usage.

Conclusion

Kenalog-40 maintains a steady position in the corticosteroid market owing to its proven efficacy, safety profile, and broad applicability. Recent clinical trials reinforce its therapeutic versatility and safety, which are crucial for sustained market relevance. Market dynamics point toward moderate growth driven by regional expansion, indication diversification, and clinical innovation. Strategic focus on expanding approved indications, optimizing dosing strategies, and addressing safety concerns will be pivotal for stakeholders aiming to capitalize on this corticosteroid asset.

Key Takeaways

• Clinical innovation continues to support Kenalog-40's utility, with ongoing trials exploring new indications and optimizing administration techniques.
• Market stability is maintained through its established safety profile and affordability, though emerging biologics pose competitive pressures.
• Regional expansion, notably in Asia-Pacific, and expanding indications are key growth drivers.
• Safety management remains critical, as adverse effects can influence long-term usage and prescribing patterns.
• Future growth hinges on regulatory approvals for new indications, formulation improvements, and integration into combination therapies.

FAQs

1. What are the main future indications being explored for Kenalog-40?
Trials are investigating its use in treating resistant keloids, hypertrophic scars, alopecia areata, and juvenile autoimmune conditions, with the goal of expanding its approved therapeutic scope[2].

2. How does Kenalog-40 compare to newer biologic treatments?
While biologics target specific immune pathways and offer high efficacy with potentially fewer side effects locally, Kenalog-40 remains favored for localized inflammatory conditions due to its established safety profile, cost-effectiveness, and ease of administration.

3. Are there significant safety concerns associated with long-term use of Kenalog-40?
Prolonged or high-dose use can lead to skin atrophy, pigmentation changes, and systemic effects like adrenal suppression, emphasizing the importance of appropriate dosing and monitoring.

4. How might regional regulatory changes impact the Kenalog-40 market?
New safety regulations or stricter labeling requirements could influence prescribing practices. However, approval for additional indications may open new revenue streams, especially in emerging markets.

5. What role does the generic market play for Kenalog-40?
Generics significantly enhance accessibility and affordability, securing its position in primary care settings and reducing overall treatment costs, which sustains demand amidst competition from novel therapies.

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Sources

[1] MarketsandMarkets, "Corticosteroids Market by Type and Application," 2022.
[2] ClinicalTrials.gov, database of ongoing and completed trials involving Kenalog-40.