CLINICAL TRIALS PROFILE FOR TRIAMCINOLONE

505(b)(2) Clinical Trials for Triamcinolone

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 Triamcinolone

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000569 ↗	Lung Health Study II	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1993-09-01	To determine if participants with chronic obstructive pulmonary disease, who were assigned to inhaled corticosteroids had a lower rate of decline in lung function and lower incidence of respiratory morbidity compared to participants assigned to placebo.
NCT00000569 ↗	Lung Health Study II	Completed	University of Minnesota	Phase 3	1993-09-01	To determine if participants with chronic obstructive pulmonary disease, who were assigned to inhaled corticosteroids had a lower rate of decline in lung function and lower incidence of respiratory morbidity compared to participants assigned to placebo.
NCT00000569 ↗	Lung Health Study II	Completed	University of Minnesota - Clinical and Translational Science Institute	Phase 3	1993-09-01	To determine if participants with chronic obstructive pulmonary disease, who were assigned to inhaled corticosteroids had a lower rate of decline in lung function and lower incidence of respiratory morbidity compared to participants assigned to placebo.
NCT00000577 ↗	Asthma Clinical Research Network (ACRN)	Withdrawn	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1993-09-01	This study will establish a network of interactive asthma clinical research groups to evaluate current therapies, new therapies, and management strategies for adult asthma.
NCT00000577 ↗	Asthma Clinical Research Network (ACRN)	Withdrawn	Milton S. Hershey Medical Center	Phase 3	1993-09-01	This study will establish a network of interactive asthma clinical research groups to evaluate current therapies, new therapies, and management strategies for adult asthma.
NCT00021294 ↗	Eflornithine With or Without Triamcinolone in Preventing Nonmelanoma Skin Cancer in Patients With Actinic Keratosis	Completed	National Cancer Institute (NCI)	Phase 2	2001-05-01	RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Eflornithine with or without triamcinolone may be effective in preventing nonmelanoma skin cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of eflornithine with or without triamcinolone in preventing nonmelanoma skin cancer in patients who have actinic keratosis.
NCT00021294 ↗	Eflornithine With or Without Triamcinolone in Preventing Nonmelanoma Skin Cancer in Patients With Actinic Keratosis	Completed	University of Arizona	Phase 2	2001-05-01	RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Eflornithine with or without triamcinolone may be effective in preventing nonmelanoma skin cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of eflornithine with or without triamcinolone in preventing nonmelanoma skin cancer in patients who have actinic keratosis.

Clinical Trial Conditions for Triamcinolone

Condition Name

Condition Name for Triamcinolone
Intervention	Trials
Diabetic Macular Edema	36
Macular Edema	19
Oral Lichen Planus	14
Diabetic Retinopathy	13

Condition MeSH

Condition MeSH for Triamcinolone
Intervention	Trials
Macular Edema	80
Edema	63
Osteoarthritis	31
Macular Degeneration	25

Clinical Trial Locations for Triamcinolone

Trials by Country

Trials by Country for Triamcinolone
Location	Trials
United States	513
Canada	43
Egypt	37
India	32
Brazil	21

Trials by US State

Trials by US State for Triamcinolone
Location	Trials
California	38
Pennsylvania	27
New York	27
Texas	26
Florida	26

Clinical Trial Progress for Triamcinolone

Clinical Trial Phase

Clinical Trial Phase for Triamcinolone
Clinical Trial Phase	Trials
Phase 4	103
Phase 3	65
Phase 2/Phase 3	33

Clinical Trial Status

Clinical Trial Status for Triamcinolone
Clinical Trial Phase	Trials
Completed	205
Unknown status	65
Recruiting	49

Clinical Trial Sponsors for Triamcinolone

Sponsor Name

Sponsor Name for Triamcinolone
Sponsor	Trials
Shahid Beheshti University of Medical Sciences	16
National Eye Institute (NEI)	14
Cairo University	14

Sponsor Type

Sponsor Type for Triamcinolone
Sponsor	Trials
Other	443
Industry	90
NIH	22

Triamcinolone: Clinical Trials, Market Analysis, and Projections

Introduction to Triamcinolone

Triamcinolone is a synthetic corticosteroid belonging to the class of glucocorticoids, which mimic the natural hormones produced by the adrenal glands. It is widely used for its potent anti-inflammatory and immunosuppressive properties, treating a variety of conditions including allergies, asthma, arthritis, skin disorders, and ocular inflammatory conditions.

Clinical Trials and Real-World Data

Recent Clinical Trials and Studies

A significant update in the clinical landscape of triamcinolone involves the use of real-world data to understand patient responses. At the 2024 Retina World Congress, Dr. Michael A. Singer presented a study using the IRIS database to analyze the real-world use of triamcinolone acetonide for treating uveitic macular edema via suprachoroidal injection. This study found that:

• Duration of Activity: 75% of patients did not require any steroid rescue over a six-month period, and 87% did not need another intravitreal injection of steroid during this time[4].
• Patient Population: The study highlighted that 40% of the treated patients had a history of IOP elevation or glaucoma, indicating the medication's suitability for high-risk patient populations[4].

These findings align closely with clinical trial data, such as the PEACHTREE analysis, but with fewer booster shots needed in real-world scenarios.

Relaunch of Triamcinolone Acetonide Injectable Suspension

Harrow has announced the successful manufacture of the first commercial-scale process performance qualification (PPQ) batch of triamcinolone acetonide injectable suspension (Triesence), which has been on the FDA Drug Shortage List for over five years. The completion of the remaining PPQ batches is expected to allow Harrow to relaunch the product in 2024, addressing the significant shortage in the US market[1].

Market Analysis

Global Market Size and Growth

The global triamcinolone market is experiencing steady growth driven by several key factors:

• Market Size: The market was valued at USD 874.2 million in 2023 and is projected to grow at a CAGR of 3.4% from 2024 to 2032, reaching USD 1.15 billion by 2025 and further to USD 1.93 billion by 2033 in some estimates[2][5].
• Growth Drivers: The increasing prevalence of chronic inflammatory diseases such as asthma, arthritis, and allergies, along with the rise in the geriatric population, are significant drivers. Technological advancements in injection delivery systems and the exploration of new therapeutic applications also contribute to market growth[2][3][5].

Market Segmentation

The triamcinolone market is segmented based on type, application, and end-user:

• Type: The market includes creams, injections, inhalers, and other types. The cream segment held the majority of the market share in 2023 and is anticipated to grow at a CAGR of 3.6% over the coming years[5].
• Application: The market is dominated by applications such as eczema, dermatitis, allergies, and psoriasis. The eczema segment led the market with a revenue of about USD 377.7 million in 2023[5].
• End-User: The market is segmented into drug stores, hospitals, and other end-users. Drug stores secured a leading share of about 66.2% in 2023 and are anticipated to grow at a CAGR of 3.7% during the forecast period[5].

Regional Analysis

• North America: This region accounted for 40.5% of the global market share in 2023 and is predicted to reach USD 458.9 million by 2032. The U.S. market, in particular, was valued at USD 305.9 million in 2023 and is anticipated to grow at a CAGR of 3.2% over the forecast period[5].
• Europe and Asia: Germany and India are expected to show significant growth during the forecast period, driven by increasing awareness and the availability of efficient active ingredients[5].

Market Trends

Combination Therapies

There is a growing trend towards combining triamcinolone with other drugs to enhance treatment outcomes. For instance, triamcinolone can be combined with tacrolimus, isotretinoin, and cyclosporine to address complex skin conditions like oral lichen planus. These combination therapies provide synergistic effects and improved outcomes compared to using triamcinolone alone[5].

New Drug Delivery Systems

The development of new drug delivery systems such as transdermal patches, liposomal formulations, and nano-emulsions is enhancing the market. These systems improve skin penetration and reduce the side effects associated with triamcinolone, making it more patient-friendly[5].

Regulatory Approvals

The growth in regulatory approvals for new and advanced triamcinolone formulations is positively impacting the market. These approvals increase the availability and accessibility of triamcinolone, contributing to revenue growth[5].

Key Takeaways

• Clinical Trials: Real-world data studies are validating the efficacy of triamcinolone in various applications, including ocular inflammatory conditions.
• Market Growth: The global triamcinolone market is projected to grow significantly, driven by the increasing prevalence of chronic diseases and technological advancements.
• Segmentation: The market is segmented by type, application, and end-user, with creams and eczema treatment being dominant segments.
• Regional Focus: North America, particularly the U.S., is a leading market, with significant growth expected in regions like Germany and India.
• Market Trends: Combination therapies and new drug delivery systems are key trends driving market growth.

FAQs

What is the current market size of the triamcinolone market?

The global triamcinolone market was valued at USD 874.2 million in 2023 and is projected to reach USD 1.93 billion by 2033[2][5].

What are the primary drivers of the triamcinolone market growth?

The primary drivers include the increasing prevalence of chronic inflammatory diseases, the rise in the geriatric population, and technological advancements in injection delivery systems[2][3][5].

Which region dominates the triamcinolone market?

North America, particularly the United States, dominates the triamcinolone market, accounting for 40.5% of the global market share in 2023[5].

What are the common applications of triamcinolone?

Triamcinolone is commonly used to treat conditions such as eczema, dermatitis, allergies, psoriasis, and various ocular inflammatory conditions[5].

Are there any new developments in triamcinolone formulations?

Yes, there is a focus on developing new drug delivery systems like transdermal patches, liposomal formulations, and nano-emulsions to enhance skin penetration and reduce side effects[5].

Sources

1. Harrow Provides Triamcinolone Acetonide Injectable Suspension Relaunch Update. Ophthalmology Times.
2. Triamcinolone Acetonide Injection Market's Evolution: Key Growth Drivers. Data Insights Market.
3. Triamcinolone Market Statistics, Trends | Forecast - 2033. Allied Market Research.
4. RWC 2024: An IRIS database look at triamcinolone acetonide. Modern Retina.
5. Triamcinolone Market 2024 – 2032 Industry Growth Report. Global Market Insights.

Last updated: 2025-01-06