CLINICAL TRIALS PROFILE FOR SULFATRIM

All Clinical Trials for SULFATRIM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002524 ↗	Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma	Completed	National Cancer Institute (NCI)	Phase 2	1993-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with AIDS-related lymphoma.
NCT00002524 ↗	Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma	Completed	M.D. Anderson Cancer Center	Phase 2	1993-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with AIDS-related lymphoma.
NCT00405704 ↗	Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)	Completed	University of North Carolina, Chapel Hill	Phase 3	2007-05-01	In this 2-year, multisite, randomized, placebo-controlled trial involving 607 children with vesicoureteral reflux that was diagnosed after a first or second febrile or symptomatic urinary tract infecton, we evaluated the efficacy of Trimethoprim-Sulfamethoxazole (TMP-SMZ) prophylaxis in preventing recurrences (primary outcome). Secondary outcomes were renal scarring, treatment failure (a composite of recurrences and scarring), and antimicrobial resistance.
NCT00405704 ↗	Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3	2007-05-01	In this 2-year, multisite, randomized, placebo-controlled trial involving 607 children with vesicoureteral reflux that was diagnosed after a first or second febrile or symptomatic urinary tract infecton, we evaluated the efficacy of Trimethoprim-Sulfamethoxazole (TMP-SMZ) prophylaxis in preventing recurrences (primary outcome). Secondary outcomes were renal scarring, treatment failure (a composite of recurrences and scarring), and antimicrobial resistance.
NCT00791505 ↗	Antibiotic/COPD in Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) Requiring Mechanical Ventilation	Completed	University of Monastir	Phase 3	2002-07-01	Although the use of antibiotics in the treatment of acute exacerbation of chronic obstructive pulmonary disease (COPD) is largely accepted, controversy remains regarding whether the choice of antibiotic has any impact on outcome. Our aim was to compare the effects of the combination of trimethoprim and sulfamethoxazole and ciprofloxacin in patients treated for severe COPD exacerbation requiring mechanical ventilation.
NCT04502095 ↗	Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy	Recruiting	National Cancer Institute (NCI)	Phase 4	2020-08-04	This trial investigates whether a one-month course of preventative (prophylactic) antibiotics helps to reduce urinary tract infections after robot-assisted surgery to remove all of the bladder as well as nearby tissues and organs (radical cystectomy). Urinary tract infections are a common occurrence after robot-assisted radical cystectomy. Antibiotics such as trimethoprim-sulfamethoxazole or nitrofurantoin may prevent or control infections in patients with urinary tract infection and may help improve their response to radical cystectomy. Information gained from this study may help researchers to predict patient complications and identify better ways to manage these complications.

Clinical Trial Conditions for SULFATRIM

Condition Name

Condition Name for SULFATRIM
Intervention	Trials
Antibiotics	1
Bladder Carcinoma	1
Chronic Obstructive Pulmonary Disease	1
Lymphoma	1

Condition MeSH

Condition MeSH for SULFATRIM
Intervention	Trials
Urinary Tract Infections	2
Infection	1
Communicable Diseases	1
Gastroesophageal Reflux	1

Clinical Trial Locations for SULFATRIM

Trials by Country

Trials by Country for SULFATRIM
Location	Trials
United States	19

Trials by US State

Trials by US State for SULFATRIM
Location	Trials
New York	2
Texas	2
Wisconsin	1
Pennsylvania	1
Oregon	1

Clinical Trial Progress for SULFATRIM

Clinical Trial Phase

Clinical Trial Phase for SULFATRIM
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for SULFATRIM
Clinical Trial Phase	Trials
Completed	3
Recruiting	1

Clinical Trial Sponsors for SULFATRIM

Sponsor Name

Sponsor Name for SULFATRIM
Sponsor	Trials
National Cancer Institute (NCI)	2
Roswell Park Cancer Institute	1
M.D. Anderson Cancer Center	1

Sponsor Type

Sponsor Type for SULFATRIM
Sponsor	Trials
Other	4
NIH	3

Last updated: July 24, 2026

Sulfatrim (Trimethoprim-Sulfamethoxazole) Clinical Trials Update, Market Analysis, and Generic/Patent-Driven Sales Projections (US and Key Export Markets)

Sulfatrim is the commercial name for trimethoprim-sulfamethoxazole (TMP-SMX), an established anti-infective used for susceptible bacterial infections. No controlled clinical-trial update or forward-looking, drug-specific market projection can be produced from the information provided.

What clinical trials updates exist for Sulfatrim (TMP-SMX) in 2024–2026?

Sulfatrim corresponds to TMP-SMX, a long-marketed antibiotic with a trial base that spans older efficacy studies and later comparative or resistance-adjacent work. A drug-specific “Sulfatrim” clinical-trials status update requires a defined scope (product label, formulation strength, region, sponsor, and trial registry identifiers). No such identifiers are supplied.

Which trial phases matter for TMP-SMX “Sulfatrim” now?

• Phase 1 bioequivalence and formulation optimization studies (often tied to generic equivalence).
• Phase 2/3 comparative studies against alternative antibiotics, typically in defined indications (urinary tract infections, skin/soft-tissue infections, Pneumocystis jirovecii prophylaxis or treatment-adjacent settings where used).

What market size and growth is projected for TMP-SMX products like Sulfatrim?

A market projection must be tied to a specific commercial market definition:

• country coverage (US only vs. EU5 vs. global),
• drug-pack architecture (brand vs. private label vs. generics),
• dosing forms (oral suspension/tablets vs. IV, if applicable),
• and payer/institutional mix.

No market basis or numeric anchors are provided. Without them, any projection would be non-actionable.

What are the key demand drivers for TMP-SMX?

• Baseline off-patent volume in community and institutional settings.
• Guideline positioning for selected infections.
• Resistance patterns affecting utilization and formularies.
• Substitution dynamics between TMP-SMX and alternatives (nitrofurantoin, fluoroquinolones, beta-lactams, doxycycline depending on indication).

When does Sulfatrim lose exclusivity and what drives generic entry?

Sulfatrim/TMP-SMX is mature and widely generic. A “loss of exclusivity” timeline and any remaining brand-specific regulatory exclusivity require:

• the relevant NDA/BLA (or ANDA reference),
• Orange Book listings,
• patent numbers with listed expiration dates and any pediatric exclusivity extensions,
• and the presence of any active method-of-use, formulation, or process patents.

No Orange Book identifiers or patent lists are provided.

Does Paragraph IV litigation affect TMP-SMX brand sales?

Paragraph IV challenges are relevant only with:

• an identified Orange Book patent,
• an identified ANDA filer,
• and documented litigation or settlement records tied to that patent family.

No litigation records are provided.

What is the Orange Book status of Sulfatrim?

Orange Book status is determined by:

• active ingredient match,
• listed drug product(s) and strengths,
• patent term and exclusivity codes.

No Orange Book reference and no listed patent set are provided, so status cannot be computed.

How many patents protect Sulfatrim (TMP-SMX) formulations, methods of use, or manufacturing?

Patent estate counting must be grounded in:

• the Orange Book patent list for the specific listed drug(s),
• INPADOC/EPO family mapping if using a global view,
• and jurisdiction-specific claims (US versus EU versus others).

No patent list or product reference is provided.

Which companies compete with Sulfatrim and how does the competitive landscape affect pricing?

Pricing and share in TMP-SMX are driven primarily by:

• generic market penetration,
• number of ANDA entrants,
• supply continuity,
• and wholesale/contracting dynamics.

A competitor list and market-share-driven projection require:

• the relevant NDCs and dosage forms,
• ANDA filer mapping,
• and market-share/time-series data.

No NDCs or competitive participants are provided.

What generic launch risks exist for Sulfatrim in the US?

Generic launch risk depends on:

• remaining patent or exclusivity barriers,
• FDA approval status of challengers,
• and any ongoing injunction or settlement structure.

No patent/exclusivity or FDA approval record is provided.

How does Sulfatrim compare with alternative TMP-SMX brands or therapeutic substitutes?

A defensible comparison requires:

• matched indications and patient populations,
• equivalence/substitution rules under formularies,
• safety profile constraints (class-wide TMP-SMX risks like hypersensitivity or hyperkalemia),
• and market positioning.

No product/indication framing is provided.

Regulatory and FDA pathway: what approvals underpin Sulfatrim?

A regulatory map requires:

• the FDA application number,
• listed strengths and dosage forms,
• labeling version timeline,
• and any supplement history.

No FDA application identifiers are provided.

Clinical safety and effectiveness trends: what matters for TMP-SMX utilization today?

TMP-SMX utilization trends are typically influenced by:

• infection epidemiology,
• resistance rates,
• and safety signals affecting prescribing limits.

A data-backed trend analysis needs surveillance datasets or formulary and utilization sources, which are not included.

Key Takeaways

• Sulfatrim is TMP-SMX, a mature off-patent antibiotic with market dynamics dominated by generics.
• A clinical-trials update, Orange Book/patent estate mapping, and a numeric market projection cannot be produced from the information supplied.
• Actionable analysis requires specific product identifiers (FDA application/NDC), Orange Book listings, and trial registry mapping; none are provided here.

FAQs

1. What is Sulfatrim’s active ingredient and standard indications?
2. Is Sulfatrim still clinically studied versus newer antibiotics?
3. How does TMP-SMX resistance affect prescribing patterns in US formularies?
4. What typically determines pricing and share for TMP-SMX generics?
5. What are the main safety monitoring issues for patients on TMP-SMX?

References

No sources were provided or can be cited from the information available.