clinicians

Tigilanol tiglate canine


An intratumoural pharmaceutical for
the treatment of mast cell tumours (MCTs)

Pharmaceutical indicated for the treatment of mast cell tumours in dogs

Tigilanol tiglate is approved for treating mast cell tumours (MCT) in dogs, removing 75% of tumours with a single treatment (p=0.0001).1

It is a first-in-class, small molecule approved by the European Medicines Agency (EMA), the UK Veterinary Medicines Directorate (VMD) and Swissmedic as an oncology pharmaceutical for the treatment of all grades of non metastatic MCT in dogs.2

Link to EU SPC and UK-VMD

USA and Australian regulatory status

Applications for marketing authorisation are currently under late-stage review by the US Food and Drug Administration – Center for Veterinary Medicines (FDA-CVM) and the Australian Pesticides and Veterinary Medicines Authority (APVMA). Our
medium-term objective is for veterinarians across the globe to have access to tigilanol tiglate, as another treatment in their tool-kit.

Proactive lifecycle management

Our Phase IV programme is currently underway to explore the potential of additional solid tumour indications.

 
 

OUR STORY

2000

EcoBiotics established to discover novel, biologically active chemicals from the Queensland rainforests
 

2000

EcoLogic™ independent validation of Ecologic discovery process
 

2000

Private rainforest access privately held rainforests signed for biodiscovery purposes
 

2002-2004

State government rainforest access Queensland State Government rainforest signed for biodiscovery purposes
 

2004

2004 QBiotics Limited established as a drug development company, a subsidiary to EcoBiotics
 

2004

Tigilanol tiglate discovered as an anticancer compound (EBC-46)
 

2005

2005

Tigilanol tiglate patents progress to examination phase in all major regions
 

2006

2007 Tiglianol tiglate mode of action identified​
 

2007

Tigilanol tiglate clinical case studies successfully conducted with equine & canine
 

2008

Canine exploratory cases
>200 cases (89 MCT)
 

2009-2013

2010

QBiotics focus: clinical development, human and veterinary
 

2010-2014

Tigilanol tiglate patents granted
in all major markets
 

2010-2014

Canine dose characterisation
and pharmacokinetics PK (27 MCT)
 

2013

Tigilanol tiglate mode of action paper published
 

2014

2015

IND enabling toxicology complete
 
 

2015

FDA – CVM Clinic field trial
(123 MCT)
 

2015

QBiotics Group established: merger between EcoBiotics and QBiotics
 

2017

Marketing & distribution agreement
with Virbac for tigilanol tiglate veterinary in EU, UK and USA
 

2018

EMA regulatory submission
of tigilanol tiglate as a canine MCT treatment
 

2019

APVMA regulatory submission​
 

2019

Swissmedic regulatory submission​
 

2019

FDA regulatory submission
of tigilanol tiglate as a canine MCT treatment
 

2019

2020

EMA approval for tigilanol tiglate as a canine MCT treatment
 

2020

Merck Sharp & Dohme collaboration deal​
 

2020

Swissmedic approval​ for tigilanol tiglate as a canine MCT treatment
 

2020


References:

  1. De Ridder TR et al. Journal of Veterinary Internal Medicine 2020;doi:10.1111/jvim.15806
  2. Tigilanol tiglate Summary of Product Characteristics v 5018-en.