CLINICAL TRIALS PROFILE FOR DIRITHROMYCIN

All Clinical Trials for dirithromycin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02099240 ↗	Patients Response to Early Switch To Oral:Osteomyelitis Study	Terminated	James Graham Brown Cancer Center	Early Phase 1	2014-03-06	Based on the current literature, investigators hypothesize that patients with osteomyelitis who are treated with the standard approach of intravenous antibiotics for the full duration of therapy will have the same clinical outcomes as patients treated with the experimental approach of intravenous antibiotics with early switch to oral antibiotics. The primary objective of this study is to compare patients with osteomyelitis treated with the standard approach of intravenous antibiotics for the full duration of therapy versus patients treated with intravenous antibiotics with an early switch to oral antibiotics in relation to clinical outcomes at 12 months after discontinuation of antibiotic therapy. Secondary objectives of the study include the evaluation of adverse events related to the use of antibiotics as well as the cost of care evaluated from the hospital perspective.
NCT02099240 ↗	Patients Response to Early Switch To Oral:Osteomyelitis Study	Terminated	University of Louisville	Early Phase 1	2014-03-06	Based on the current literature, investigators hypothesize that patients with osteomyelitis who are treated with the standard approach of intravenous antibiotics for the full duration of therapy will have the same clinical outcomes as patients treated with the experimental approach of intravenous antibiotics with early switch to oral antibiotics. The primary objective of this study is to compare patients with osteomyelitis treated with the standard approach of intravenous antibiotics for the full duration of therapy versus patients treated with intravenous antibiotics with an early switch to oral antibiotics in relation to clinical outcomes at 12 months after discontinuation of antibiotic therapy. Secondary objectives of the study include the evaluation of adverse events related to the use of antibiotics as well as the cost of care evaluated from the hospital perspective.
NCT02099240 ↗	Patients Response to Early Switch To Oral:Osteomyelitis Study	Terminated	Julio Ramirez	Early Phase 1	2014-03-06	Based on the current literature, investigators hypothesize that patients with osteomyelitis who are treated with the standard approach of intravenous antibiotics for the full duration of therapy will have the same clinical outcomes as patients treated with the experimental approach of intravenous antibiotics with early switch to oral antibiotics. The primary objective of this study is to compare patients with osteomyelitis treated with the standard approach of intravenous antibiotics for the full duration of therapy versus patients treated with intravenous antibiotics with an early switch to oral antibiotics in relation to clinical outcomes at 12 months after discontinuation of antibiotic therapy. Secondary objectives of the study include the evaluation of adverse events related to the use of antibiotics as well as the cost of care evaluated from the hospital perspective.
NCT02185833 ↗	Bioequivalence Pilot Study of Dirithromycin of (Abdi İbrahim İlaç San.Ve.Tic.A.Ş,Turkey) in Healthy Subjects Under Fasting Condition	Completed	Abdi Ibrahim Ilac San. ve Tic A.S.	Phase 1	2014-06-01	To assess the bioequivalence of the investigational TEST product with the marketed REFERENCE products by measurement of Plasma concentrations of Erythromycylamine and calculation of the bioequivalence parameters from those measurements followed by ANOVA and 90% confidence interval statistical evaluation.
NCT02185833 ↗	Bioequivalence Pilot Study of Dirithromycin of (Abdi İbrahim İlaç San.Ve.Tic.A.Ş,Turkey) in Healthy Subjects Under Fasting Condition	Completed	Pharmaceutical Research Unit, Jordan	Phase 1	2014-06-01	To assess the bioequivalence of the investigational TEST product with the marketed REFERENCE products by measurement of Plasma concentrations of Erythromycylamine and calculation of the bioequivalence parameters from those measurements followed by ANOVA and 90% confidence interval statistical evaluation.

Clinical Trial Conditions for dirithromycin

Condition Name

Condition Name for dirithromycin
Intervention	Trials
Healthy	4
Osteomyelitis	1

Condition MeSH

Condition MeSH for dirithromycin
Intervention	Trials
Disease	4
Osteomyelitis	1

Clinical Trial Locations for dirithromycin

Trials by Country

Trials by Country for dirithromycin
Location	Trials
Jordan	4
United States	1

Trials by US State

Trials by US State for dirithromycin
Location	Trials
Kentucky	1

Clinical Trial Progress for dirithromycin

Clinical Trial Phase

Clinical Trial Phase for dirithromycin
Clinical Trial Phase	Trials
Phase 1	4
Early Phase 1	1

Clinical Trial Status

Clinical Trial Status for dirithromycin
Clinical Trial Phase	Trials
Completed	4
Terminated	1

Clinical Trial Sponsors for dirithromycin

Sponsor Name

Sponsor Name for dirithromycin
Sponsor	Trials
Abdi Ibrahim Ilac San. ve Tic A.S.	4
Pharmaceutical Research Unit, Jordan	4
James Graham Brown Cancer Center	1

Sponsor Type

Sponsor Type for dirithromycin
Sponsor	Trials
Other	7
Industry	4

Last updated: May 23, 2026

rithromycin Clinical Trials Update, Market Analysis, and Revenue Projection (2026–2036)
Dirithromycin is a macrolide antibiotic with limited modern-market footprint in most major geographies. Current, actionable clinical-trials and regulatory-status intelligence is not available in the provided input, so a complete, defensible update on trial progress, competitive positioning, and revenue projections cannot be produced to the standards required for licensing, litigation, regulatory, or investment decisions.

Clinical trials update for dirithromycin: what phase studies are ongoing and what endpoints matter?
No verifiable, source-grounded information is provided on: (1) active trial registries, (2) trial phase distribution (Phase 1–3), (3) enrollment status, (4) primary endpoints (e.g., microbiologic eradication rate, clinical cure, safety), or (5) top-line results and timelines.

How does dirithromycin’s market position compare with azithromycin and clarithromycin?
No market-share, prescribing, reimbursement, or sales-history inputs are provided for dirithromycin, nor for adjacent competitors (azithromycin, clarithromycin, telithromycin). A defensible comparative assessment requires at minimum: geography-specific sales, formulary tier placement, and antibiotic-class utilization metrics.

When does dirithromycin lose exclusivity, and are there Orange Book patents relevant to generics?
No Orange Book drug product mapping (application/letter status, listed patents, expiration dates, exclusivity codes), no patent numbers, and no exclusivity timelines are provided. Without that, any exclusivity or generic-entry assessment would be noncompliant with a hard-data patent analysis standard.

What patent estate protects dirithromycin, and how strong is it against generic entry?
No patent list (composition, formulation, method-of-use, polymorphs, manufacturing) and no jurisdiction coverage is provided. A strength assessment (coverage breadth vs. generic design-around) requires specific patent IDs, claims scope indicators, and expiration/maintenance status.

What is the FDA and EMA status of dirithromycin, and what pathway governs updates?
No regulatory listing status is provided for FDA (NDA/ANDA/505(b)(2)), EMA (MA authorization status, variations), or other regulators. A clinical update and market projection depend on whether the product is actively marketed, withdrawn, or restricted by label changes.

Market analysis for dirithromycin: what does demand look like by geography and indication?
No sales baseline, indication mix, or epidemiology/antimicrobial-resistance drivers are provided. Without: (1) country-level prescribing trends, (2) hospital vs. community share, (3) competing formulary coverage, and (4) guideline placement, any projection would not be grounded.

Revenue projection for dirithromycin (2026–2036): what adoption and pricing scenarios drive the model?
No historical sales series, no pricing/reimbursement assumptions, and no capacity/manufacturing constraints inputs are provided. A projection model requires at minimum: current revenue baseline, unit consumption, net price, duration of supply, and forecast inputs tied to regulatory/trial/competitive events.

Key Takeaways
No source-grounded clinical-trials update, regulatory status, patent/exclusivity assessment, or market projection for dirithromycin can be produced from the provided information.

FAQs

1. What does the latest clinicaltrials.gov record show for dirithromycin enrollment and results?
2. What is the most recent FDA/Orange Book status for dirithromycin drug products and listed patents?
3. Is dirithromycin currently marketed in the US, EU, and key emerging markets, and under what indications?
4. Which patents (composition, formulation, method-of-use) most constrain generic or 505(b)(2) strategies for dirithromycin?
5. How do dirithromycin’s labeled outcomes compare with azithromycin and clarithromycin in key guideline-listed infections?

References (APA)
No sources were provided in the input.