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Directory Entry

Paclitaxel in Veterinary Oncology: Formulation and Regulatory-History Profile

Chemotherapy · Prescription Drug · Single-agent Chemotherapy · Taxane antineoplastic agents · Dogs · During Chemotherapy · New Diagnosis
Common name: paclitaxelEditorial source check: Dog Tumor Editorial Team (editorial review; not licensed veterinary review)Last reviewed: Aug 12, 2026Official link: Visit
Directory entry:This page explains what the product, drug, herb, chemotherapy approach, or supportive-care option is. For step-by-step use or monitoring, read related Guides and consult a veterinarian.
Entry kind
Generic drug
Product family
Taxane antineoplastic agents

Quick summary

paclitaxel is covered as taxane antineoplastic agents; hazardous antineoplastic medicine, with species, evidence, regulatory, safety, interaction and monitoring boundaries for a veterinarian-led decision.

What it is

Taxane antineoplastic agents; hazardous antineoplastic medicine. Paclitaxel.

Active ingredients / formula

Paclitaxel.

Mechanism / rationale

Paclitaxel stabilises microtubules and prevents their normal disassembly, arresting dividing cells during mitosis. Vehicle and formulation are clinically inseparable from the active molecule because conventional polyethoxylated castor-oil formulations can provoke severe hypersensitivity in dogs.

How it is discussed in tumor care

Veterinary studies have evaluated micellar, nanoparticulate and newer oral formulations in dogs with selected malignancies. A formulation-specific result cannot be transferred to conventional paclitaxel or to another taxane.

Potential role

Veterinary studies have evaluated micellar, nanoparticulate and newer oral formulations in dogs with selected malignancies. A formulation-specific result cannot be transferred to conventional paclitaxel or to another taxane.

Typical use context

Formulation-dependent clinic treatment; conventional intravenous vehicles can be unsafe in dogs

Evidence snapshot

A multicentre randomized canine trial evaluated a water-soluble micellar formulation in nonresectable mast-cell tumours. More recent early-phase work evaluated oral paclitaxel with a transporter inhibitor. These studies show clinical investigation, not universal equivalence or a current broadly authorised veterinary product.

Related class overview: Taxane chemotherapy, formulation, infusion and evidence. This page remains the drug-specific profile; the linked page explains the broader class.

Safety notes

Myelosuppression, gastrointestinal effects and formulation-related hypersensitivity are central. Infusion reactions can be acute and serious; oral combinations add their own interaction and absorption issues.

Interactions / cautions

Premedication, infusion equipment, formulation excipients and transporter inhibitors are protocol-specific. Substituting a human formulation or another paclitaxel product can materially change safety and exposure.

Regulatory status

The EMA Paccal Vet marketing-authorisation application was withdrawn in 2012 after the committee could not conclude a positive benefit-risk balance. It must not be described as an authorised current EU veterinary product. This Directory page does not establish a current FDA-approved canine paclitaxel cancer product.

Regions, labels and market differences

Veterinary availability and lawful extra-label use vary. Historical or investigational formulations are not proof of current commercial authorisation.

Monitoring plan

A specialist verifies the exact formulation, evidence for the tumour, venous or oral plan, premedication and emergency readiness. Baseline and follow-up blood counts and organ assessment are protocol-specific. Breathing change, collapse, infusion-site pain, fever or severe gastrointestinal signs require urgent review.

Questions to ask your veterinarian

  • Does the confirmed diagnosis and species match the evidence population?
  • What is labelled, conditionally authorised or extra-label in this region?
  • Which objective findings will define benefit, toxicity and a change in plan?
  • What household handling, waste and urgent-contact instructions apply?

Sources and further reading