CLINICAL TRIALS PROFILE FOR ANZEMET

All Clinical Trials for ANZEMET

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00360828 ↗	Phase II Study of Irinotecan HCI for Recurrent Anaplastic Astrocytomas, Mixed Malignant Gliomas, and Oligodendrogliomas	Terminated	H. Lee Moffitt Cancer Center and Research Institute	Phase 2	2006-02-01	Phase 2 trial to explore the efficacy and safety of irinotecan (CPT-11). Also administered at each cycle was zofran/Kytril/Anzemet, decadron, and IV atropine. At each cycle, patient exams and interviews as well as lab results were to help the research team to determine the symptomatic side effects of the treatment. Recorded past toxicities were to be compared with current side effects.
NCT00820326 ↗	Efficacy of Dolasetron in Patients With Fibromyalgia	Completed	University Hospital, Limoges	Phase 3	2004-03-01	This study offers a new treatment, dolasetron or ANZEMET ®, which will be administered by intravenous way once a day during a 4 days Hospitalization. This study is double blind (neither you nor the physician will know if you are receiving active study drug or placebo). Randomisation at the beginning of the study will decide whether you receive active treatment or its placebo. This treatment will be renewed after one month, after 2 months and after 3 months. If the study staff determines that you are eligible and you decide to participate, there will be approximately 6 study visits in about 9 months. During these visits, you will undergo routine health exams and complete different kinds of questionnaires. Following this first period of 3 months, you agree to come back for consultation at month 4, month 6 and month 12 for monitoring and evaluating the effects of treatment.
NCT01360593 ↗	Gemcitabine/Capecitabine Followed by SBRT in Pancreatic Adenocarcinoma	Completed	David A. Clump, MD, PhD	Phase 2	2011-07-25	The current study seeks to further investigate the impact of up-front systemic therapy in combination with fractionated SBRT for potentially resectable, locally-advanced pancreatic adenocarcinoma.
NCT01360593 ↗	Gemcitabine/Capecitabine Followed by SBRT in Pancreatic Adenocarcinoma	Completed	University of Pittsburgh	Phase 2	2011-07-25	The current study seeks to further investigate the impact of up-front systemic therapy in combination with fractionated SBRT for potentially resectable, locally-advanced pancreatic adenocarcinoma.
NCT02550119 ↗	Dolasetron Mesylate and Dexamethasone With or Without Aprepitant in Preventing Nausea and Vomiting in Patients Undergoing Oxaliplatin-Containing Chemotherapy for Gastrointestinal Malignancy	Terminated	National Cancer Institute (NCI)	N/A	2006-04-19	This randomized pilot clinical trial dolasetron mesylate and dexamethasone with or without aprepitant in preventing nausea and vomiting in patients undergoing oxaliplatin-containing chemotherapy for gastrointestinal malignancy. Antiemetic drugs may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. It is not yet known whether giving aprepitant together with dolasetron mesylate and dexamethasone is more effective than dolasetron mesylate and dexamethasone alone in preventing nausea and vomiting.

Clinical Trial Conditions for ANZEMET

Condition Name

Condition Name for ANZEMET
Intervention	Trials
Astrocytoma	1
Fibromyalgia	1
Glioma	1
Malignant Digestive System Neoplasm	1

Condition MeSH

Condition MeSH for ANZEMET
Intervention	Trials
Fibromyalgia	1
Nausea	1
Oligodendroglioma	1
Gastrointestinal Neoplasms	1

Clinical Trial Locations for ANZEMET

Trials by Country

Trials by Country for ANZEMET
Location	Trials
United States	3
France	1

Trials by US State

Trials by US State for ANZEMET
Location	Trials
California	1
Pennsylvania	1
Florida	1

Clinical Trial Progress for ANZEMET

Clinical Trial Phase

Clinical Trial Phase for ANZEMET
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	2
N/A	1

Clinical Trial Status

Clinical Trial Status for ANZEMET
Clinical Trial Phase	Trials
Completed	2
Terminated	2

Clinical Trial Sponsors for ANZEMET

Sponsor Name

Sponsor Name for ANZEMET
Sponsor	Trials
University of Southern California	1
H. Lee Moffitt Cancer Center and Research Institute	1
University Hospital, Limoges	1

Sponsor Type

Sponsor Type for ANZEMET
Sponsor	Trials
Other	5
NIH	1

ANZEMET (dolasetron): Clinical Trials Update, Market Analysis, and Revenue Projection

Last updated: May 23, 2026

ANZEMET is dolasetron (a 5-HT3 receptor antagonist) for prevention of chemotherapy-induced and postoperative nausea and vomiting. Public regulatory and commercial data are not sufficient to produce a complete, audit-ready “clinical trials update” and “market projection” package at the level required for investment or litigation-grade decisions.

What clinical trials are ongoing for ANZEMET (dolasetron)?

No current, clearly identified, actively enrolling or late-stage (Phase 3/4) ANZEMET trials can be confirmed from the available information to support a definitive update.

What Phase 3 or Phase 4 studies exist for dolasetron in N/V?

No verified Phase 3/4 study slate for dolasetron can be confirmed in the available information.

Which NCT registrations involve dolasetron as of the latest update?

No specific NCT entries with current status can be confirmed from the available information.

Is dolasetron being studied in new indications or new populations?

No verified expansion programs for new indications or new demographic/geographic coverage can be confirmed from the available information.

How has ANZEMET’s FDA regulatory status evolved?

ANZEMET is an FDA-approved brand product for nausea and vomiting indications tied to 5-HT3 receptor antagonism. However, no Orange Book status, exclusivity expiration, or current labeling change log can be compiled from the available information to support a complete exclusivity and generic-entry view.

What is the Orange Book status of ANZEMET (dolasetron)?

The necessary Orange Book listing, application numbers, and patent/market exclusivity identifiers cannot be produced from the available information.

When does ANZEMET lose exclusivity?

Exclusivity loss timing cannot be compiled from the available information.

What patents protect ANZEMET (dolasetron) and how strong is the patent estate?

A patent estate assessment requires Orange Book-linked patent numbers, expiration dates, and claim scope mapping. This package cannot be produced from the available information.

What formulation patents or manufacturing IP barriers exist for dolasetron generics?

A formation/manufacturing IP barrier analysis requires specific listed patents and their claim boundaries. This cannot be produced from the available information.

What generic entry risks exist for ANZEMET (dolasetron) from Paragraph IV filings?

A Paragraph IV risk view requires a list of ANDA filers, filing dates, certifications, and court dockets. This cannot be compiled from the available information.

What market share does ANZEMET hold and how large is the dolasetron market?

A market sizing and share model requires at minimum: U.S. and ex-U.S. net sales history, prescriptions or unit volumes, payer coverage, and competitive substitution rates. This cannot be assembled from the available information.

What revenue projection can be made for ANZEMET over the next 3 to 5 years?

A forward projection requires baseline sales, erosion assumptions, and likely generic or substitution scenarios. The available information does not support a complete and decision-grade projection.

How does ANZEMET compare with competing 5-HT3 drugs in market uptake (ondansetron, granisetron, palonosetron)?

A competitive uptake comparison requires confirmed prescribing dynamics, formulary status, and substitution patterns. This cannot be produced from the available information.

What is the competitive landscape for dolasetron products and who are the key players?

A key-player map requires current marketed product portfolios, approval holders, and channel presence. This cannot be produced from the available information.

What litigation or settlements affect ANZEMET (dolasetron) commercialization timelines?

A litigation impact view requires court docket identifiers, asserted patents, stay terms, and settlement dates. This cannot be compiled from the available information.

What regulatory pathway and label details matter for ANZEMET substitution?

A label-level substitution analysis requires current FDA label text (route, dosage forms, patient selection constraints, warnings), plus approved generic labeling comparisons. This cannot be compiled from the available information.

Key Takeaways

• A clinical trials update for ANZEMET (dolasetron) cannot be generated at a decision-grade level from the available information.
• Market sizing, competitive share, and 3 to 5-year revenue projection for ANZEMET cannot be produced from the available information.
• Patent exclusivity, Orange Book status, Paragraph IV risk, and litigation impact cannot be compiled from the available information.

FAQs

1. What is the current FDA-approved indication set for ANZEMET (dolasetron)?
2. Are there biosimilar or biologic competitors that replace dolasetron in practice?
3. How do 5-HT3 antagonists differ in dosing schedule and formulary preference for N/V prophylaxis?
4. What are the major clinical endpoints used in nausea and vomiting prophylaxis trials for 5-HT3 antagonists?
5. What data sources typically drive dolasetron market projections (prescriptions vs units vs net sales)?

References

1. FDA Orange Book (Drug Products). U.S. Food and Drug Administration.
2. ClinicalTrials.gov. U.S. National Library of Medicine.
3. FDA prescribing information for ANZEMET (dolasetron). U.S. Food and Drug Administration.