HYDERABAD: For diabetes patients who find the insulin shots painful, a relief is on the cards. In about two to three years, controlling your blood sugar levels may become as easy as spraying your insulin dose into the mouth, if Hyderabad-based NiedlFree Technologies Pvt Ltd has its way.

NiedlFree Technologies, set up two years ago as an associate company of Hyderabad-based R&D company Transgene Biotek Ltd, claims to have become the first globally to have cracked the holy grail of diabetes treatment with the development of a painless and needle-free oral insulin spray – called Ozulin – for use in animals and humans.

The company has already applied to the Central Drugs Standard Control Organisation (CDSCO) for approval to conduct safety and toxicology studies, after completion of which it will go for human clinical trials, Dr K Koteswara Rao, co-founder and director of NiedlFree Technologies and CMD of Transgene Biotek, told TOI on Wednesday.

NiedlFree has already been granted global patents covering over 40 countries for the novel oral insulin, Dr Rao said.
NiedlFree is also working on developing oral and nasal sprays for treatment for ailments such as cancer, osteoporosis and Alzeimer’s, and plans to raise $225-250 million over the next couple of years to put the drugs into the market, Koteswara Rao said.
Pointing out that the global market for the treatment of Type 1 and Type 2 diabetes was pegged at around US$78 billion in 2022, Rao said the company expects to revolutionise diabetes care with Ozulin, which has demonstrated a bioavailability of over 91% compared to the injectable route, in a recently concluded independent study in dogs carried out by Palamur Biosciences. “The results provide ample proof of the effectiveness of our oral insulin.

The doses were administered in the form of a liquid spray into the mouth,” he said. Rao pointed out that many global biopharma players have been trying to develop oral insulin, but have met with little success so far in ensuring that a sufficient amount of insulin makes its way into the bloodstream. “We have been able to demonstrate relative bioavailability of more than 90% insulin in the blood stream as compared to injectable insulin.

This we could achieve as we have been able to encapsulate human insulin into functionalised nano particles, which ensures that insulin is delivered optimally into the blood stream with a prolonged release,” he explained. He said the company plans to roll out the oral insulin for pets (mainly dogs and cats) in 2024-25.