Last Updated: September 24, 2026

CLINICAL TRIALS PROFILE FOR TRIAMCINOLONE


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

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

Clinical Trial Conditions for triamcinolone

Condition Name

Condition Name for triamcinolone
Intervention Trials
Diabetic Macular Edema 36
Oral Lichen Planus 20
Macular Edema 19
Diabetic Retinopathy 13
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Condition MeSH

Condition MeSH for triamcinolone
Intervention Trials
Macular Edema 81
Edema 63
Osteoarthritis 33
Osteoarthritis, Knee 32
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Clinical Trial Locations for triamcinolone

Trials by Country

Trials by Country for triamcinolone
Location Trials
United States 546
Egypt 51
Canada 43
India 34
China 25
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Trials by US State

Trials by US State for triamcinolone
Location Trials
California 42
Pennsylvania 30
New York 30
Texas 28
Florida 28
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Clinical Trial Progress for triamcinolone

Clinical Trial Phase

Clinical Trial Phase for triamcinolone
Clinical Trial Phase Trials
PHASE4 19
PHASE3 8
PHASE2 13
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Clinical Trial Status

Clinical Trial Status for triamcinolone
Clinical Trial Phase Trials
Completed 226
RECRUITING 70
Unknown status 65
[disabled in preview] 76
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Clinical Trial Sponsors for triamcinolone

Sponsor Name

Sponsor Name for triamcinolone
Sponsor Trials
Shahid Beheshti University of Medical Sciences 16
Cairo University 15
National Eye Institute (NEI) 14
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Sponsor Type

Sponsor Type for triamcinolone
Sponsor Trials
Other 509
Industry 94
NIH 23
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Last updated: July 28, 2026

Triamcinolone Clinical Trials Update, Market Analysis, and Forecast: What’s in the Pipeline, Who Sells It, and When Does Pricing Pressure Hit?

Triamcinolone is an established corticosteroid used across multiple approved formulations (injectable, intranasal, topical, dental/oral, and inhaled depending on product). Because the drug is long off-patent in most jurisdictions and sold as both multisource generics and branded products, “pipeline value” is driven more by formulation IP, device/delivery IP, and payer-driven substitution than by a single unified late-stage drug dossier. Commercial upside and downside map to (1) category growth in inflammatory conditions, (2) competitive density in each formulation class, and (3) reimbursement and switching dynamics rather than single-event clinical readouts.

The market outlook is therefore formulation-specific. Clinical activity is mostly incremental: new combinations, new delivery systems, new indications or line extensions, and head-to-head or non-inferiority studies that support label expansion or product switching.


What clinical trials are ongoing for triamcinolone right now?

Featured snippet answer: Clinical trial activity for triamcinolone today is predominantly incremental (new formulations/delivery, adjunctive regimens, or label expansions by route and indication). Late-stage, registration-driving trials are less common than earlier-stage studies and small pivotal datasets in niche indication-label expansion programs.

Which triamcinolone routes attract the most trials?

  1. Intranasal triamcinolone (allergic rhinitis, nasal polyps, sinusitis-related studies)

    • Typical study types: comparative efficacy vs other intranasals, symptom score endpoints, and safety/tolerability assessments.
    • Trial drivers: payer preference for once-daily dosing, device convenience, and branded differentiation in formularies.
  2. Topical triamcinolone (dermatologic inflammation)

    • Trial drivers: potency equivalency, vehicle and residence-time improvements, and irritation profiles.
    • Common study designs: vehicle-controlled efficacy, minimal systemic exposure comparisons, and local tolerability.
  3. Oral/dental triamcinolone (oral mucosal inflammation)

    • Trial drivers: localized inflammation control with reduced systemic exposure.
    • Study endpoints: lesion resolution, pain scores, recurrence/flare timing.
  4. Injectable triamcinolone (inflammatory joint/tendon/soft tissue indications)

    • Trial drivers: comparative outcomes vs other steroids, dosing regimens, and safety in specific populations.
    • Key endpoints: pain scale reduction and functional improvement over weeks to months.
  5. Inhaled triamcinolone (where marketed)

    • Trial drivers: chronic airway inflammation and comparative delivery performance (device and particle size equivalence where applicable).

Trial readouts that tend to move labels and formularies

  • Non-inferiority or superiority in symptom scores (intranasal, topical).
  • Composite endpoints that support step therapy reversal (e.g., rapid onset plus sustained control).
  • Safety packages that support restricted-use transitions (e.g., lower local adverse events).

Pipeline reality check for triamcinolone

  • Triamcinolone is widely generic. Most “trial updates” do not create exclusivity.
  • Value creation depends on: (a) distinct combination products, (b) distinct delivery devices, (c) new indication claims with enforceable method-of-use or formulation IP, and (d) manufacturing/particle or vehicle IP where generics face differentiation constraints.

What is triamcinolone’s market size by formulation and where is growth coming from?

Featured snippet answer: Growth is primarily category-driven in inflammatory diseases, with incremental volume increases coming from substitution within each route (for example, among intranasal steroids) and regional brand retention where reimbursement favors specific products.

Market segmentation that matters for forecasts

Because “triamcinolone” is not a single commercial product, forecasts should be segmented by:

  • Route: intranasal vs topical vs dental/oral vs injectable
  • Strength and dose form: creams/ointments, sprays, suspensions, dental pastes, etc.
  • Channel: retail pharmacy vs institutional/hospital (injectable usage)
  • Geography: US, EU-5, UK, Canada, LATAM, APAC

Growth drivers by route

  • Intranasal: allergic rhinitis prevalence trends, chronic sinus inflammation management, and patient adherence improvements with device/once-daily products.
  • Topical: atopic dermatitis and other inflammatory dermatoses treated in outpatient settings; switch from older topical steroids based on safety and vehicle tolerability.
  • Injectable: orthopedic and outpatient pain management; procedural volume is the key macro driver.
  • Oral/dental: dental inflammation and mucositis subsets that support periodic use.

Cost drivers and competitive intensity

  • Generic substitution is the baseline.
  • Competitive intensity increases where:
    • multiple ANDAs exist for the same strength and route
    • payer formularies prefer lowest net cost
    • wholesalers and PBMs favor standardized NDC lists

Who are the major triamcinolone sellers and competitive landscape by route?

Featured snippet answer: Competitive sets differ sharply by route because the products are often marketed as distinct branded or generic SKUs with different NDCs and device types.

US commercial landscape (how it typically looks)

  • Intranasal: multiple ANDA/bioequivalent options with brand-equivalent substitution. Device and formulary placement determine share more than molecule-level differentiation.
  • Topical: dense generic competition. Brand share varies by vehicle/potency class and contract pricing.
  • Injectable: hospital/institution procurement drives share; tendering can shift volumes quickly.

Europe and Canada dynamics

  • Strong substitution and tendering in EU member states and Canada compress prices.
  • Brand retention tends to be local and contract-driven rather than IP-driven.

When does triamcinolone lose exclusivity and how do patent expirations affect pricing?

Featured snippet answer: For triamcinolone itself, molecule-level exclusivity is largely exhausted in most markets. Market effects now come from expiring formulation/device patents (where present) and from periodic generic entries rather than from a single end-of-exclusivity event.

What “exclusivity” means for triamcinolone today

  • Brand exclusivity (where still present) is typically limited to specific formulations, strengths, or delivery features.
  • Generic entry timing depends on:
    • ANDA approval dates
    • patent landscape for specific NDCs (formulation/process/method-of-use)
    • any Orange Book-listed patents tied to the exact product

Practical impact on pricing

  • After a product-specific patent barrier clears, price compression is typically rapid in the US retail channel and even faster in tendered institutional markets.

What is the Orange Book status of triamcinolone products and which patents are most relevant?

Featured snippet answer: Triamcinolone products are mostly covered by limited remaining Orange Book listings in specific branded configurations; the core molecule is off-patent. Relevant patents are usually formulation, method-of-use, or device-related, tied to particular NDCs.

Patent categories that matter for triamcinolone

  • Formulation patents: suspension stability, particle size ranges, viscosity targets, excipient blends, preservatives.
  • Method-of-use patents: dosing regimens and indication-specific regimens (often weakly enforceable once generic labeling is broad).
  • Process patents: manufacturing conditions for particle size or suspension uniformity.
  • Device patents: spray mechanics, delivery geometry, and actuation profiles (where applicable).

Paragraph IV risk profile

  • Because many entries are already generic, Paragraph IV litigation risk is concentrated in:
    • any remaining branded NDCs with enforceable Orange Book patents
    • late-cycle formulation/combination products tied to specific delivery systems

Are any biosimilar or biologic substitution risks relevant to triamcinolone?

Featured snippet answer: No direct biosimilar pathway exists for triamcinolone itself because it is a small-molecule corticosteroid, not a biologic. The competitive risk is therapeutic substitution by other classes: intranasal corticosteroids, topical steroids, and steroid-sparing biologics (for severe chronic inflammatory disease subsets).

Where therapeutic substitution shows up

  • Severe allergic rhinitis reframed toward biologics in select patients
  • Moderate-to-severe dermatology where systemic therapies compete with topical steroids

What patent litigation affects triamcinolone generics and how likely is further Paragraph IV activity?

Featured snippet answer: Litigation is usually product-specific for remaining branded NDCs, not molecule-wide. The more the market is already generic, the lower the incremental value of new Paragraph IV challenges unless a specific branded formulation retains enforceable patents.

Litigation pattern by route

  • Intranasal: fewer but more meaningful barriers if device or formulation is patented.
  • Topical: dense filings; litigation tends to be opportunistic unless there is a specific patented vehicle/process.
  • Injectable: often governed by supply contracts and institutional procurement, so disputes are less visible but can be strategically important.

What generic entry risks exist for triamcinolone branded products?

Featured snippet answer: Generic entry risk exists where specific NDCs still have Orange Book-listed patents. In practice, risk manifests as price drops after launch rather than as delayed supply due to litigation across many NDCs.

Where to look for entry risk

  • Branded SKUs with recent ANDA approvals or labeling carve-outs.
  • Any NDC with remaining formulation/process patents.
  • Products with restricted dosing claims that generics may be able to argue around.

How does triamcinolone compare with alternative steroids in key markets?

Featured snippet answer: Triamcinolone competes in each route against other corticosteroids in the same class. Competitive differentiation is usually device convenience, dosing schedule, local tolerability profile, and net price after PBM and wholesaler rebates.

Intranasal steroid comparison (decision drivers)

  • Once-daily vs twice-daily convenience
  • Device preference and patient adherence
  • Contract pricing in major formularies

Topical steroid comparison (decision drivers)

  • Vehicle tolerability (ointment vs cream vs lotion)
  • Potency equivalence and labeling
  • Local adverse-event rates (burning, irritation)

Injectable steroid comparison (decision drivers)

  • Onset profile and perceived duration of action
  • Procurement pricing and tender terms
  • Safety profile in targeted patient subgroups

Market projection for triamcinolone through 2030: what to expect on revenue, volume, and price

Featured snippet answer: Revenue growth is likely modest in aggregate because generic substitution compresses price, while volume growth is supported by continued inflammatory disease treatment demand and substitution within routes. The main upside comes from geography with slower substitution and from formulation-level differentiation that preserves contract share.

Forecast mechanics that fit the market reality

  1. Unit growth tracks epidemiology and adherence.
  2. Price per unit tracks generic competition intensity by route and region.
  3. Share shifts track formulary placement and tender outcomes.

Scenario framework (directional)

  • Base case: steady unit demand growth, continued price pressure from multisource availability.
  • Bear case: faster substitution in key formularies and tighter reimbursement compress net pricing.
  • Bull case: durable contract share for differentiated branded SKUs in intranasal/topical, and slower generic penetration in select geographies.

What this means for investors and licensors

  • “Patent-driven” revenue uplift is limited at the molecule level.
  • Value creation most often occurs through:
    • owning IP around a differentiated formulation/device NDC
    • securing long-term supply contracts for injectables
    • leveraging brand positioning for intranasal/topical adherence

Key takeaways

  • Triamcinolone clinical activity is mostly incremental, with value concentrated in formulation, delivery, and label extensions rather than molecule-level exclusivity.
  • Market growth is route-specific and driven by inflammatory disease demand plus adherence and contract placement.
  • Pricing power is constrained by generic density; major swings follow product-specific launches tied to remaining Orange Book barriers.
  • Competitive outcomes depend on PBM formularies and institutional procurement terms more than on new clinical “headline” results.

FAQs

1) What are the most common clinical outcomes endpoints used in triamcinolone intranasal trials?

Symptom scores (nasal congestion, rhinorrhea, sneezing), global assessment, time-to-onset, and safety/tolerability with local adverse event reporting.

2) Which triamcinolone formulation typically faces the highest generic price pressure?

Topical triamcinolone vehicles and creams/ointments with dense ANDA competition tend to see the fastest net price compression.

3) Are there any ongoing triamcinolone combination product trials?

Trials most often target adjunctive regimens or alternative delivery combinations where label expansion is intended; the dominant commercial value still comes from formulation-specific differentiation rather than molecule exclusivity.

4) Does triamcinolone have biosimilar competitors?

No. Biosimilars are not relevant to triamcinolone itself; the main substitution risk is therapeutic class switching to other anti-inflammatory modalities.

5) What is the most reliable driver of triamcinolone revenue in institutional settings?

Procedural and procurement volume tied to pain/inflammation management and tender contract outcomes for injectable products.


References

  1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
  2. ClinicalTrials.gov. Search results for triamcinolone (public registry).

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