Research and development
BIKY Pharma's development pipeline illustrates our commitment to innovative therapies to meet major public health needs. Our approach covers several therapeutic areas: pain management with INADIX and medical cannabis, smoking cessation with NICØDIØL, and the treatment of respiratory pathologies such as COPD and asthma via the administration of Salbutamol and Terbutaline. Currently, we have completed preclinical development for NICØDIØL and are aiming to launch Phase I in 2026.
For COPD/asthma, a collaboration with the École des Mines de Saint-Étienne began in 2024, strengthening our research and development efforts. For INADIX, BIKY Pharma is pursuing a regulatory trajectory in France aimed at an ad hoc Marketing Authorization. At the same time, the company is preparing its first access to the Swiss market, scheduled for October 2026, as part of extemporaneously compounded preparations. This roadmap illustrates our vision of progressive development, adapted to the regulatory frameworks of each market, focused on quality, innovation and patient needs.
Therapeutic areas
Exploration
Preclinical development
Phase 1
Phase 2
Phase 3
Pain management
INADIX
Medical cannabis
Smoking cessation NICØDIØL
COPD / Asthma
Salbutamol – Terbutaline
Cannabis withdrawal
NICØDIØL is the first drug candidate developed by BIKY Pharma focused on smoking cessation. We are developing the first electronic tobacco and nicotine substitute by vaporization. We combine our BIKY Breathe Batterie vaporization device coupled with vaporizable liquid formulations combining two active ingredients, nicotine and cannabidiol (CBD) in its isolate form.
NICØDIØL
Treatment characteristics
An innovative withdrawal protocol using a step system allowing a transition from the addictive molecule (nicotine) to the non-addictive cannabidiol to promote smoking cessation, then nicotine and therapeutic cessation.
Rapid kinetics linked to inhalation favoring rapid passage into the blood network then to the central nervous system (CNS).
Improved bioavailability compared to oral forms without going through a metabolization phase in the body.
The modularity of the device allows rapid delivery of active ingredients to satisfy cravings and promotes adaptability to the needs of each patient in their smoking cessation process.
Phase I&II Clinical Trials (pharmacokinetics and proof of effectiveness) with the first inclusions planned for 2026
INADIX
Treatment characteristics
A vaporizable liquid formulation with THC dominance.
A microdosing for each inhalation as well as rapid kinetics linked to the pulmonary route of administration make it possible to limit the quantity of active ingredients administered to optimize the dose/effect ratio while avoiding an overdose mainly characterized by the “high effect” linked to too high a dose of THC administered.
The principle of modularity via the device coupled to the formulation allows comfort for the patient after each inhalation in their pain management with an administered dose large enough to manage their pain but too low to cause side effects such as the “high effect”.
Through a vaporizable liquid solution we respond to two main challenges, firstly providing a solution for patients in need of cannabis medications with rapid kinetics which allows them to better manage their pain peaks and thus improve their quality of life and secondly responding to a major public health issue via a non-combustible inhalable solution that is reliable in terms of dosage.
In France, BIKY Pharma is pursuing a regulatory trajectory for INADIX aimed at an ad hoc Marketing Authorization. At the same time, the company is preparing its first access to the Swiss market in October 2026, as part of extemporaneously compounded preparations carried out and delivered under the responsibility of authorized healthcare professionals.
The third drug candidate developed by BIKY Pharma concerns respiratory health with a treatment for COPD (Chronic Obstructive Pulmonary Disease), also the third cause of preventable death in the world, directly linked to our first theme which concerns smoking cessation. COPD is commonly characterized as “smoker’s bronchitis”.
Objective, to allow short-acting bronchodilators to be administered as first-line treatment for people with the onset of COPD to attenuate and potentially make the beginnings of the disease disappear. Approach intended for smoking patients.
Simple use of the vaporization device will increase the effectiveness of the treatment in the sense that there is no need for hand, mouth inhalation coordination to correctly administer the active ingredients used and respond to a problem with dry powder inhalers (DPI) or metered dose inhalers (MDI) on the market, with the addition of a 0% Co2 emission solution (no propellant gases) in its use. Education of the smoking patient on the device may be carried out in the event that the smoking patient uses the same vaporization device as that for the drug candidate NICØDIØL dedicated to smoking cessation which is indicated as first intention to stop the progression of the disease.
PCBØ
Treatment characteristics
Administration of bronchodilators by vaporization allowing rapid and immediate action on the pulmonary target area allowing rapid dilation of the bronchi and an instantaneous effect felt by the patient after inhalation.
Phase I clinical trials on kinetics planned for 2026 in collaboration with the Biological Activity of Inhaled Principles (BioPi) department of the Saint Etienne School of Mines.
Exploration of the development of a potential treatment developed by BIKY Pharma for cannabis withdrawal.
Currently there is no recognized treatment for cannabis withdrawal in the world. With its expertise in smoking cessation with the development of NICØDIØL, which presents strong similarities with cannabis withdrawal, and coupled with the achievement of a formulation with a strong THC dominance in the context of pain management through INADIX, BIKY Pharma is exploring the possibility of pushing forward the development of the very first treatment for cannabis withdrawal which would be made possible through specific formulations (already identified and formulated) coupled to an innovative weaning protocol.
Codependency and the virtuous circle
Multifactorial dependence
There is a multifactorial dependence of cannabis smokers just as for tobacco smokers, that is to say a physical, psychological and behavioral dependence which is often coupled with a codependence on nicotine. BIKY Pharma would best understand this multidimensional complexity of this codependency which requires the use of several complementary medications. Using the same device to administer these different medications would promote the patient approach and total cannabis withdrawal. First phase I clinical trials are planned for 2026
Maximize the health benefit
There is a correlation between our drug candidates which, depending on the patients' pathologies, often multiple, leads to an overall positive effect beyond the initially targeted treatment. For example, a smoker with chronic pain and diagnosed with the onset of COPD, stopping smoking would promote the treatment of COPD, which would also promote a better daily life with better sleep, which would have an impact on pain management with a physique more capable of managing certain occasional crises... We will speak of a virtuous circle of health, where a specific medical approach at the origin will potentiate the health benefit through the use of other medications which themselves can reinforce/cumulate their effects positive between them for the general well-being of the patient and thus improve their quality of life, between prevention, improvement and treatment.