All Clinical Trials for SULFADIAZINE

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Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000666 ↗	A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV-Infected Individuals With Serologic Evidence of Latent Toxoplasma Gondii Infection	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To evaluate pyrimethamine as a prophylactic agent against toxoplasmic encephalitis in individuals who are coinfected with HIV and latent Toxoplasma gondii. Toxoplasmic encephalitis is a major cause of illness and death in AIDS patients. Standard treatment for toxoplasmic encephalitis is to combine pyrimethamine and sulfadiazine. Continuous treatment is necessary to prevent recurrence of the disease, but constant use of pyrimethamine/sulfadiazine is associated with toxicity. Clindamycin has been shown to be effective in treatment of toxoplasmic encephalitis in animal studies. This study evaluates pyrimethamine as a preventive treatment against toxoplasmic encephalitis (per 3/26/91 amendment, clindamycin arm was discontinued).
NCT00000674 ↗	A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS	Completed	Glaxo Wellcome	N/A	1969-12-31	To collect information on the effectiveness and toxicity of clindamycin plus pyrimethamine and leucovorin calcium for the treatment of acute toxoplasmic encephalitis in adult patients with AIDS. Toxoplasmic encephalitis (encephalitis caused by Toxoplasma gondii) is the most frequent cause of focal central nervous system infection in patients with AIDS. If untreated, the encephalitis is fatal. At present, it is standard practice to give a combination of pyrimethamine and sulfadiazine to treat toxoplasmic encephalitis. The high frequency of sulfonamide-induced toxicity in AIDS patients often makes completion of a full course of therapy difficult. There is some information that high doses of parenteral (such as by injection) clindamycin used with pyrimethamine may be as effective as pyrimethamine plus sulfadiazine in the management of the acute phase of toxoplasmic encephalitis in patients with AIDS. Administration of parenteral clindamycin for prolonged periods of time, however, is costly, requires hospitalization, and is inconvenient for the patient. There is some indication that treatment of AIDS patients with acute toxoplasmic encephalitis with oral clindamycin may be effective. Leucovorin calcium is useful in preventing pyrimethamine-associated bone marrow toxicity.
NCT00000674 ↗	A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS	Completed	Upjohn	N/A	1969-12-31	To collect information on the effectiveness and toxicity of clindamycin plus pyrimethamine and leucovorin calcium for the treatment of acute toxoplasmic encephalitis in adult patients with AIDS. Toxoplasmic encephalitis (encephalitis caused by Toxoplasma gondii) is the most frequent cause of focal central nervous system infection in patients with AIDS. If untreated, the encephalitis is fatal. At present, it is standard practice to give a combination of pyrimethamine and sulfadiazine to treat toxoplasmic encephalitis. The high frequency of sulfonamide-induced toxicity in AIDS patients often makes completion of a full course of therapy difficult. There is some information that high doses of parenteral (such as by injection) clindamycin used with pyrimethamine may be as effective as pyrimethamine plus sulfadiazine in the management of the acute phase of toxoplasmic encephalitis in patients with AIDS. Administration of parenteral clindamycin for prolonged periods of time, however, is costly, requires hospitalization, and is inconvenient for the patient. There is some indication that treatment of AIDS patients with acute toxoplasmic encephalitis with oral clindamycin may be effective. Leucovorin calcium is useful in preventing pyrimethamine-associated bone marrow toxicity.
NCT00000674 ↗	A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To collect information on the effectiveness and toxicity of clindamycin plus pyrimethamine and leucovorin calcium for the treatment of acute toxoplasmic encephalitis in adult patients with AIDS. Toxoplasmic encephalitis (encephalitis caused by Toxoplasma gondii) is the most frequent cause of focal central nervous system infection in patients with AIDS. If untreated, the encephalitis is fatal. At present, it is standard practice to give a combination of pyrimethamine and sulfadiazine to treat toxoplasmic encephalitis. The high frequency of sulfonamide-induced toxicity in AIDS patients often makes completion of a full course of therapy difficult. There is some information that high doses of parenteral (such as by injection) clindamycin used with pyrimethamine may be as effective as pyrimethamine plus sulfadiazine in the management of the acute phase of toxoplasmic encephalitis in patients with AIDS. Administration of parenteral clindamycin for prolonged periods of time, however, is costly, requires hospitalization, and is inconvenient for the patient. There is some indication that treatment of AIDS patients with acute toxoplasmic encephalitis with oral clindamycin may be effective. Leucovorin calcium is useful in preventing pyrimethamine-associated bone marrow toxicity.
NCT00000794 ↗	Phase II Randomized Open-Label Trial of Atovaquone Plus Pyrimethamine and Atovaquone Plus Sulfadiazine for the Treatment of Acute Toxoplasmic Encephalitis	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To evaluate the efficacy, safety, and tolerance of atovaquone with either pyrimethamine or sulfadiazine in AIDS patients with toxoplasmic encephalitis. AIDS patients with toxoplasmic encephalitis who receive the standard therapy combination of sulfadiazine and pyrimethamine experience a high frequency of severe toxicity. Atovaquone, an antibiotic that has demonstrated efficacy against toxoplasmosis in animal models and in preclinical testing has been well tolerated, is now available as a suspension, which is more readily absorbed than the tablet form of the drug. The efficacy and safety of atovaquone in combination with sulfadiazine or pyrimethamine will be studied.
>Trial ID	>Title	>Status	>Sponsor	>Phase	>Start Date	>Summary

Condition Name for SULFADIAZINE
HIV Infections	6
Burns	5
Toxoplasmosis, Cerebral	5
Burn	3
[disabled in preview]	1
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Condition MeSH for SULFADIAZINE
Burns	12
Toxoplasmosis	8
HIV Infections	6
Encephalitis	5
[disabled in preview]	1
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Trials by Country for SULFADIAZINE
United States	52
China	6
Canada	5
Brazil	3
Iran, Islamic Republic of	2
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Trials by US State for SULFADIAZINE
New York	5
California	5
Illinois	4
Maryland	4
Virginia	4
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Clinical Trial Phase for SULFADIAZINE
PHASE4	1
Phase 4	5
Phase 3	5
[disabled in preview]	8
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Clinical Trial Status for SULFADIAZINE
Completed	22
Unknown status	4
Terminated	1
[disabled in preview]	2
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Sponsor Name for SULFADIAZINE
National Institute of Allergy and Infectious Diseases (NIAID)	5
Glaxo Wellcome	3
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara	3
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Sponsor Type for SULFADIAZINE
Other	30
Industry	8
NIH	6
[disabled in preview]	0
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Last updated: July 27, 2026

Sulfadiazine clinical trials update, market analysis, and market projection (2024-2035)

What is sulfadiazine’s current clinical development status and why does it matter for next launches?

Status summary: Sulfadiazine is an established, off-patent sulfonamide antibiotic. Clinical “updates” are typically limited to (1) new formulations (topical/combination), (2) safety surveillance and pharmacovigilance studies, and (3) niche trials in specific geographies, indications, or special populations rather than broad, late-stage registrational programs.

Typical trial patterns seen in real-world registries for older antibacterials

Small, investigator-led pharmacokinetic or bioavailability studies when a new formulation is used (oral suspension changes, topical vehicle changes, or fixed-dose combinations).
Comparative effectiveness studies in settings where sulfadiazine is used as part of guideline-driven empiric or targeted therapy.
Safety-focused studies: hypersensitivity, hematologic adverse events (e.g., agranulocytosis), renal stone risk, and monitoring protocols.
TDM/PK-adjacent work (less common) for patient populations with renal impairment or complex comedications.

Indication reality check Sulfadiazine’s clinical use base is largely driven by established clinical practice rather than brand-driven new-drug development. Market entry timing and competition are therefore more sensitive to:

availability of generic supply,
price erosion in the antibiotic class,
and any incremental regulatory actions (e.g., discontinuations, manufacturing changes, or formulation-specific approvals), than to “next trial readouts.”

Where is sulfadiazine used clinically today (oral vs topical), and what patient groups drive demand?

Primary clinical use pattern (high level):

Oral sulfadiazine is used for susceptible bacterial infections per local formularies and clinician practice.
Topical sulfadiazine is used for burn wound care (classically silver sulfadiazine cream/ointment in many markets).
In some regions, sulfadiazine appears in combination regimens for specific infectious diseases depending on resistance patterns and guideline updates.

Demand drivers

Burn care protocols: if a local formulary keeps silver sulfadiazine in standard burn dressing pathways, it can create stable institutional demand even as systemic antibiotic demand fluctuates.
Antimicrobial stewardship constraints: systemic sulfonamides face competition from newer antibiotic classes; uptake depends on resistance and formulary positioning.
Supply continuity: older generics are exposed to manufacturing disruptions. Any sustained supply constraints can temporarily increase utilization.

What phase of clinical trials is sulfadiazine in, and are there any pivotal registrational studies?

Answer (operational): There is no widely recognized, late-stage registrational program for sulfadiazine in major jurisdictions comparable to modern NDA/BLA cycles. Current “clinical trial activity,” when present, is usually supportive, observational, or formulation/scenario-specific.

Practical implication for stakeholders

No single near-term Phase 3 readout is typically expected to drive a major market step-change.
Market outcomes trend to be determined by pricing, supply, and regulatory continuity rather than novel clinical efficacy datasets.

How many active sulfadiazine trials are running, and which sponsors tend to conduct them?

Answer (data-dependent): A definitive “active trials count” requires live registry extraction (e.g., ClinicalTrials.gov, EU CTR). Without that live registry pull, a precise number cannot be stated without risking incorrect coverage.

What can be concluded from development economics

Sponsor activity is usually split between:
- generic manufacturers (formulation, bioequivalence),
- academics/hospitals (small observational/PK),
- public health entities (surveillance and safety monitoring where applicable).

Sulfadiazine market analysis: supply chain, price dynamics, and competitive landscape

Who sells sulfadiazine and how fragmented is the market?

Market structure: Sulfadiazine is typically sold by multiple generic manufacturers with product form fragmentation:

oral solid and liquid dosage forms,
topical creams/ointments (notably silver sulfadiazine where approved),
and sometimes fixed-dose combinations depending on country.

Fragmentation sources

product-level differentiation (cream base, concentration, packaging),
channel differentiation (hospital vs retail),
and country-specific approvals and tender frameworks (particularly for burn care).

What drives sulfadiazine pricing and margins in generic markets?

Key forces:

Generic price compression: older antibiotics face sustained downward pricing pressure.
Tender cycles in institutional care: hospital purchasing can lock in low pricing but also creates periods of inventory volatility.
Input and manufacturing constraints: any API supply disruption, regulatory manufacturing change, or quality recall can spike near-term pricing.
Substitution pressure: if alternative burn therapies (e.g., other topical antimicrobials or advanced wound dressings) are preferred, silver sulfadiazine utilization can soften.

How does sulfadiazine compare with alternative burn wound and systemic antibiotic therapies?

Burn wound space

Silver sulfadiazine competes with other topical antimicrobials and modern wound care dressings.
Clinical selection depends on formulary, clinician practice, infection control protocols, and reimbursement.

Systemic infection space

Sulfonamides compete with broader-spectrum antibiotics and guideline-driven agents based on local resistance profiles and patient risk profiles.
Sulfadiazine use is often narrower and more sensitive to stewardship restrictions.

What is the market size for sulfadiazine and what segment contributes most?

Answer (need live data to quantify): A quantified market size and segment split requires current commercial databases or country-level sales data. Without an explicit dataset pull, providing numeric market size would be unreliable.

Operational segmentation for planning

Topical burn care (institutional and chronic burn unit tenders)
Oral/systemic (retail + institutional formularies)
Geographic mix (countries with stronger continued use in burn care protocols)

Market projection for sulfadiazine (2024-2035): base case and downside/upside scenarios

When does sulfadiazine face “no-longer-available” risks vs “new-competition” risks?

No patent-driven protection cliffs Sulfadiazine’s competitive dynamics are not governed by a single blockbuster patent expiry timeline. Instead, risks come from:

generic entry saturation already having occurred,
manufacturing discontinuations,
and substitution by other products or updated guidelines.

New-competition risk

Low in the sense that entry already exists in most jurisdictions.
Still real if quality issues resolve and additional suppliers scale, adding incremental pressure to pricing.

Supply discontinuation risk

More meaningful for planning because a shortage can raise volumes and prices quickly even in off-patent markets.
Burn care institutional demand is especially sensitive to supply continuity.

What is the expected demand trajectory for sulfadiazine through 2035?

Base case (directional):

Topical burn care utilization: relatively stable to slowly declining depending on adoption of newer wound care options and evolving protocols.
Systemic use: likely stable-to-declining in many markets due to stewardship, resistance-driven selection, and competition.

Commercial outcome expectation

Revenue growth, if any, is more likely to come from:
- market share stability in formulations still preferred by clinicians,
- periodic tender wins,
- and inflationary pass-through in constrained supply conditions, than from volume expansion driven by new indications.

What determines geographic winners for sulfadiazine suppliers?

Tender inclusion in burn units and pharmacy formularies.
Regulatory continuity for topical concentrations and excipients.
Packaging and supply reliability.
Cost competitiveness against alternate topical agents and systemic alternatives.

Regulatory and patent landscape: what protection remains for sulfadiazine?

What patents protect sulfadiazine (or its key formulations), and are they still enforceable?

Answer (operational): Sulfadiazine itself is widely off-patent. Any remaining patent relevance is typically tied to:

specific formulations (especially topical silver sulfadiazine in particular concentration/vehicle),
manufacturing processes,
and method-of-use claims that may exist in some jurisdictions for specific clinical use patterns.

For market entry and litigation risk

The residual IP risk is generally lower than for patented, modern antibiotics.
A detailed, jurisdiction-by-jurisdiction patent estate review is required to name specific active patents, but that cannot be produced without a targeted patent dataset and jurisdiction scope.

What is the Orange Book status of sulfadiazine in the US?

Answer (non-quantified): Sulfadiazine products are generally listed as approved generics or legacy products, with patent listings (if any) tied to specific listed products and formulation-specific patents. A correct Orange Book mapping requires direct Orange Book record extraction by NDC/product strength.

Is there any biosimilar or complex exclusivity risk for sulfadiazine?

Answer: Not applicable. Sulfadiazine is a small molecule antibiotic, not a biologic.

Key execution implications for R&D, licensing, and commercial planning

What clinical-trial signal should investors watch for sulfadiazine?

Formulation changes that improve stability, reduce irritation, or improve burn dressing performance.
Safety/usage protocol updates that preserve formulary status (e.g., dosing/monitoring guidance for high-risk populations).
Supply chain resilience studies or manufacturing validation completions that reduce stockout risk.

What licensing opportunities realistically exist?

For an off-patent antibiotic, licensing opportunities usually take one of these forms:

acquiring distribution/channel rights in a geography,
securing exclusive supply agreements or tender participation rights,
or licensing niche formulation IP only if active, enforceable patents exist for specific products.

Key Takeaways

Sulfadiazine’s current clinical activity is typically supportive and formulation- or safety-adjacent, not driven by large Phase 3 registrational programs.
Market outcomes are driven mainly by generic supply, tender formularies, price compression, and substitution by alternative burn and antibiotic therapies.
For 2024-2035, directional demand is likely stable to modestly declining, with revenue more sensitive to pricing and supply continuity than to new clinical efficacy breakthroughs.
Patent and regulatory “cliff” risk is generally low for sulfadiazine as a class, with any remaining IP tied to specific product formulations and manufacturing/process claims that require product-level estate mapping.

FAQs

Does sulfadiazine have ongoing Phase 3 clinical trials in burn care or infection indications?

No widely recognized, pivotal Phase 3 program is the standard expectation for sulfadiazine; activity is more commonly small-scale supportive or observational.

Is silver sulfadiazine cream still used as first-line burn therapy in major countries?

Use is country- and protocol-dependent; formulary inclusion varies and can shift toward newer topical agents and dressings.

What safety risks are most monitored for sulfadiazine patients?

Hypersensitivity reactions, hematologic events, and renal stone risk are core safety monitoring themes in practice.

Can new generic entrants materially change sulfadiazine pricing?

Yes, but effect is usually incremental in already-saturated markets; the larger pricing drivers are tender wins and supply disruptions.

Are there any exclusivity periods that delay generic sulfadiazine competition?

For most off-patent sulfadiazine products, competition delay is typically limited to product-specific regulatory and patent listings, not broad drug-level exclusivity.

References

U.S. FDA, Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
ClinicalTrials.gov. Sulfadiazine.

CLINICAL TRIALS PROFILE FOR SULFADIAZINE