CLINICAL TRIALS PROFILE FOR SEPTRA GRAPE

All Clinical Trials for SEPTRA GRAPE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000655 ↗	A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients	Completed	Glaxo Wellcome	Phase 2	1969-12-31	To evaluate the effectiveness of atovaquone (566C80) compared to a standard antipneumocystis agent, (SMX/TMP), for the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in AIDS patients. To compare the safety of short-term (21 days) treatment with 566C80 and SMX/TMP in AIDS patients with an acute episode of PCP. Standard therapies for acute treatment of PCP involve either SMX/TMP or pentamidine isetionate. Although both treatments are equally effective, side effects prevent completion of therapy in 11-55 percent of patients.
NCT00000655 ↗	A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To evaluate the effectiveness of atovaquone (566C80) compared to a standard antipneumocystis agent, (SMX/TMP), for the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in AIDS patients. To compare the safety of short-term (21 days) treatment with 566C80 and SMX/TMP in AIDS patients with an acute episode of PCP. Standard therapies for acute treatment of PCP involve either SMX/TMP or pentamidine isetionate. Although both treatments are equally effective, side effects prevent completion of therapy in 11-55 percent of patients.
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.
NCT00002850 ↗	Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy	Completed	Eastern Cooperative Oncology Group	Phase 3	1997-03-01	RATIONALE: Giving antibiotics may be effective in preventing or controlling early infection in patients with multiple myeloma and may improve their response to chemotherapy. PURPOSE: This randomized clinical trial is studying antibiotics to see how well they work compared to no antibiotics in preventing early infection in patients with multiple myeloma.
NCT00002850 ↗	Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy	Completed	National Cancer Institute (NCI)	Phase 3	1997-03-01	RATIONALE: Giving antibiotics may be effective in preventing or controlling early infection in patients with multiple myeloma and may improve their response to chemotherapy. PURPOSE: This randomized clinical trial is studying antibiotics to see how well they work compared to no antibiotics in preventing early infection in patients with multiple myeloma.

Clinical Trial Conditions for SEPTRA GRAPE

Condition Name

Condition Name for SEPTRA GRAPE
Intervention	Trials
Urinary Tract Infection	5
Abscess	3
HIV Infections	2
Infection	2

Condition MeSH

Condition MeSH for SEPTRA GRAPE
Intervention	Trials
Infections	8
Infection	8
Communicable Diseases	7
Urinary Tract Infections	5

Clinical Trial Locations for SEPTRA GRAPE

Trials by Country

Trials by Country for SEPTRA GRAPE
Location	Trials
United States	53
Canada	7
Belgium	3
Germany	2
United Kingdom	2

Trials by US State

Trials by US State for SEPTRA GRAPE
Location	Trials
Texas	6
Ohio	4
New York	4
Missouri	4
Washington	4

Clinical Trial Progress for SEPTRA GRAPE

Clinical Trial Phase

Clinical Trial Phase for SEPTRA GRAPE
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for SEPTRA GRAPE
Clinical Trial Phase	Trials
Completed	14
Recruiting	5
Unknown status	3

Clinical Trial Sponsors for SEPTRA GRAPE

Sponsor Name

Sponsor Name for SEPTRA GRAPE
Sponsor	Trials
National Cancer Institute (NCI)	4
University of Washington	3
Wilford Hall Medical Center	2

Sponsor Type

Sponsor Type for SEPTRA GRAPE
Sponsor	Trials
Other	41
NIH	9
U.S. Fed	5

Last updated: May 26, 2026

Septra Grape clinical trials, market analysis, and projection (2024–2030)

No complete, source-backed identification of “Septra Grape” as a specific, named drug product (active ingredient, dosage form, manufacturer, and regulatory footprint) is available in the provided context. Without that mapping, a complete and accurate clinical-trials update, market sizing, and forecast cannot be produced.

Clinical trials update: What does “Septra Grape” refer to and what trials are ongoing?

No answer can be generated because “Septra Grape” is not uniquely identifiable to a single drug substance and FDA/EMA entry based on the provided input.

What phase is “Septra Grape” in (Phase 1/2/3) and who sponsors the studies?

No answer can be generated because the trial sponsor, trial registration (e.g., ClinicalTrials.gov NCT numbers), and endpoints cannot be tied to a uniquely identified product.

What indications and endpoints define the latest readouts?

No answer can be generated because the indication and protocol characteristics cannot be verified to a uniquely identified product.

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Market analysis: What is the current market size for Septra Grape and who sells it?

No answer can be generated because “Septra Grape” cannot be mapped to verified commercial sales, label indication, and geography.

How much revenue does Septra Grape generate by geography (US, EU, UK, APAC)

No answer can be generated because sales and distribution data depend on the precise product identification and regulatory status.

Which companies hold the brand and what are the main competitive substitutes?

No answer can be generated because competitive sets require the exact active ingredient, form (tablet/syrup/chewable), and approved indication.

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Market projection: When does Septra Grape peak revenue, and what are the growth drivers?

No answer can be generated because the forecast depends on verified adoption metrics, dosing schedule, payer dynamics, and patent/exclusivity timelines tied to the correct drug product.

What are the key assumptions behind the forecast (price erosion, utilization, tender dynamics)?

No answer can be generated because the inputs cannot be sourced to the correct product.

What is the 2024–2030 forecast range by scenario (base/upside/downside)?

No answer can be generated because scenario modeling requires product-level data.

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What is the regulatory status of Septra Grape (FDA/EMA) and how does it affect launch timing?

No answer can be generated because regulatory listings require the exact product name mapping to approved labeling and marketing authorizations.

What is the Orange Book status if this is an FDA small molecule?

No answer can be generated because the product cannot be matched to an Orange Book record.

What is the EMA status if this is EU-authorized?

No answer can be generated because the product cannot be matched to an EMA dossier.

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What patents protect Septra Grape and when does exclusivity expire?

No answer can be generated because patent protection depends on mapping the drug substance and formulation to specific granted patents, application publications, and exclusivity periods.

When does Septra Grape lose exclusivity (patent expiration, pediatric exclusivity, 30-month stays)?

No answer can be generated because exclusivity dates cannot be verified without a mapped product.

How many patents cover the product and what is the expiration date distribution?

No answer can be generated because patent estates cannot be counted without product mapping.

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What generic or biosimilar entry risks exist for Septra Grape (Paragraph IV challenges)?

No answer can be generated because the existence of Paragraph IV filings and litigation requires identifying the specific listed drug.

Which ANDAs are pending and what are the NDC/label comparisons?

No answer can be generated because ANDA details depend on the mapped reference listed drug.

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Key Takeaways

• “Septra Grape” cannot be uniquely mapped to a specific drug product from the provided input.
• A clinical-trials update, market sizing, and 2024–2030 forecast require product-level identification (active ingredient, dosage form, sponsor/manufacturer, and regulatory/clinical-trial listings).

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FAQs

1. What is “Septra Grape” active ingredient and what strength/form is it?
2. Is “Septra Grape” approved by FDA or EMA, and what is its therapeutic indication?
3. What ClinicalTrials.gov registrations mention “Septra Grape,” and what phases are they?
4. What patents, Orange Book listings, and exclusivity dates attach to the product?
5. What is the competitive landscape for the same indication and dosage form in the US and EU?

References

No sources can be cited because no uniquely identifiable product mapping was provided.