#Orx pharma trial#

Total net sales for 2021 amounted to SEK 565 million and the number of employees was 121. The main market today is the American market for buprenorphine/naloxone products, where Orexo commercializes its lead product ZUBSOLV® for treatment of opioid use disorder.

The products are commercialized by Orexo in the US or via partners worldwide. Orexo develops improved pharmaceuticals and digital therapies addressing unmet needs within the growing space of substance use disorders and mental health. Strengthened by this positive news and our constructive dialogue with the FDA, we continue working towards the goal of being able to offer an effective and safe treatment for patients with systemic sclerosis,' says Patric Stenberg, CEO of Gesynta Pharma.Īccording to the agreement, signed in 2017, Orexo will receive a tiered double digit share of future revenues that Gesynta Pharma generates from the OX-MPI (GS248) project. 'The orphan drug designation granted to our drug candidate GS-248 for the treatment of systemic sclerosis provides an opportunity for extended market exclusivity, which is a valuable complement to its strong patent protection. With a successful outcome we are confident Gesynta Pharma, with their experienced and competent management team, are well positioned to develop OX-MPI (GS-248) to a commercial success.'

#Orx pharma trial#

We are looking forward to see the result of the ongoing phase 2 trial later this year. Obtaining orphan drug status in the US, is a true milestone to ensure the pharmaceutical reaches the patients suffering from systemic sclerosis as soon as possible. Nikolaj S ø rensen, CEO & President of Orexo, commented: 'We are very pleased with the progress Gesynta Pharma has made with our former OX-MPI (GS-248) project. This exclusive classification provides up to seven years of market exclusivity and also gives some financial benefits during the development phase.

Orphan Drug Designation is intended to encourage the development of drugs for the treatment of rare diseases. The drug candidate is currently being evaluated in a clinical phase 2 trial and data is expected in late 2022. OX-MPI (GS-248) has a unique and promising mechanism of action with the potential to help both patients with systemic sclerosis and patients with other chronic inflammatory diseases. Systemic sclerosis (also known as scleroderma) is a chronic, autoimmune disease that affects, among other things, the body's smallest vessels, the microvasculature, and is associated with great medical needs due to the current lack of safe and effective medicines. A list of bone analyses that we offer in our animal models can be found in our list of bone analysis services.UPPSALA, Sweden, Ap/PRNewswire/ - Orexo AB (publ.), (STO:ORX) (OTCQX: ORXOY), announces today that the company´s partner Gesynta Pharma AB which owns all the rights to OX-MPI (GS248), a drug candidate for the treatment of systemic sclerosis, has been granted Orphan Drug Designation in the US by the Food and Drug Administration (FDA). We also provide tailored study setups for testing biosimilars and functional foods that have less extensive regulatory requirements. Pharmatest has specific standard study setups for testing compounds with anti-catabolic and anabolic bone effects. Preclinical efficacy studies can also be performed with intact male rats, or intact male mice that require lower amount of test compound. Efficacy of the best compound can then be confirmed with more extensive and longer studies. When necessary a preliminary 2-week study can be first performed for identifying the best out of several potential compounds and finding its optimal doses. Pharmatest can help you in determining the efficacy of your new drug candidates for male osteoporosis with the rat ORX model. The rat orchidectomy (ORX) model is the most commonly used animal model of androgen deficiency and male osteoporosis. The development of male osteoporosis is associated with several risk factors, including androgen deficiency.

Osteoporosis affects aging men and leads to an increased risk of bone fracture.