List of Small Molecule Pharmaceuticals Companies in Italy - 24

Adamas Biotech is a clinical stage company pioneering the development of nutraceutical-based prophylactic and therapeutic solutions for a range of clinical and wellness indications. The company is specialized in the development of bioactive molecules derived from botanicals, in particular, green tea catechins. Its initial pipeline is based on 100% natural formulations of green tea purified compounds, which are under development for use in cancer prevention, anti-aging, wound care and sports medicine.

Axxam is a leading provider of integrated discovery services across the life sciences industry with headquarters in Milan, Italy. Within the drug discovery disciplines, we support pharma, biotech companies, start-ups, patient foundations as well as academic groups in their journey from hit identification to lead generation, regardless of the therapeutic area and target class. Our services include assay development, high-throughput screening, using either Axxam's high quality compound collections (synthetic and natural) or those provided by clients, hit validation and compound management. The same science-driven approach is also applied to identify new bioactive compounds for crop protection, animal health, food, beverage, pet food, cosmetic and perfume industries.

CaSRevolution is a drug discovery company developing innovative therapies for neurodegenerative diseases.

Manufacturer of APIs Certifications - FDA inspected since 2004. Last FDA Inspection Aug 2011 - cGMP compliance - Authorized by Brazilian Ministry of Health - Filed accreditation JP PMDA .

Chiesi is an international, research-focused biopharmaceuticals group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment. By changing its legal status to a Benefit Corporation in Italy, the US, and France, Chiesi’s commitment to create shared value for society as a whole is legally binding and central to company-wide decision-making.  As a certified B Corp since 2019, we’re part of a global community of businesses that meet high standards of social and environmental impact. The company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035. With over 85 years of experience, Chiesi is headquartered in Parma (Italy), operates in 31 countries, and counts more than 6,500 employees. The Group’s research and development centre in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden.

Dompé farmaceutici is an international biopharmaceutical company involved in all activities of the pharmaceutical value chain, from research to development, production and marketing. As a long-established family company, we blend the stability that comes from our 130-year heritage with the agility and dynamism of a start-up. We can turn transformative breakthroughs into treatments because we have the right qualities and capabilities to deliver new drugs. Our 160,000 square meter R&D and production site in L’Aquila, Italy, is the heart of Dompé. Here, we conduct vital research, and produce and distribute our primary care and biotech products. Primary Care includes a broad spectrum of over-the-counter treatment solutions, prescription medications, supplements and medical devices. Our Biotech focuses on the development of treatments for rare diseases. The main therapeutic areas include pain relief, inflammation, ophthalmology, diabetes care, nutrition and oncology. In the pursuit of improving human health, our R&D strives to break through in unconventional places. This is what led us to Nerve Growth Factor (NGF), a Nobel Prize-winning discovery made in 1986. We leveraged 50 years of research to transform this discovery into a breakthrough treatment. Our human recombinant NGF, cenegermin, is the first treatment for a rare degenerative eye disease, neurotrophic keratitis. That deep appreciation of science keeps us committed to investigating neurotrophins. Our relentless pursuit in identifying new treatments for diseases allowed us to harness the potential of bioinformatics to accelerate the drug discovery process. The result is Exscalate, a structure-based virtual screening platform developed in-house and currently one of the most powerful supercomputing and artificial intelligence platforms for drug testing. We are focused on the road ahead. Our hunger to deliver what patients need from science keeps us focused on what matters. We embrace the challenge in science.

We develop first-in-class biologics for several underserved autoimmune conditions. Our therapeutic approach aims to preserve and re-establish organ cell function, transforming the treatment paradigm for intractable autoimmune diseases

IAMA Therapeutics is a late preclinical-stage pharmaceutical company raising a Series B to fund the clinical development of its lead candidate in epilepsy and neurodevelopment disorders. The Company’s lead candidate, IAMA-6, is a "best-in-class" selective NKCC1 inhibitor being developed for various orphan brain disorders, including drug-resistant epilepsy, and is expected to enter the clinic in October 2023. Other pipeline candidates include new molecular entities to target Cation Chloride Cotransporters in pediatric neuropsychiatric conditions.

The International Centre for Genetic Engineering and Biotechnology ICGEB is an intergovernmental research organisation that operates within the United Nations common system. It was established in 1983 as a Centre for excellence in research, training and technology transfer to industry in the field of biotechnology to promote sustainable global development. With over 60 Member States and 40 Affiliated Centres worldwide, it runs 46 research programmes in its own laboratories in Trieste, Italy, New Delhi, India and Cape Town, South Africa. Almost 700 people work at ICGEB comprising 550 scientific personnel. The organisation has generated almost 3000 scientific publications in the Life Sciences since 1988 and currently holds over 80 active research grants. ICGEB has awarded almost 1400 fellowships, with over 300 fellows and 150 PhD students currently on board. It has organised over 560 Meetings and Courses worldwide and has funded over 550 Collaborative Research Programme-Research Grants. It has produced and distributed over 600 movies (podcasts) of high-scientific content in 50 topics in the Life Sciences - that are freely available for download on iTunes, YouTube and on the ICGEB Web site. Active in Public Engagement and on Social Media networks, ICGEB invites, in particular, its Alumni to join the ICGEB Alumni Group on Linkedin. http://www.icgeb.org

Kither Biotech is a biopharmaceutical company that develops novel therapies for the treatment of rare pulmonary diseases with an high unmet medical need. Our first two product candidates KIT2014 and KITCL27, focus on cystic fibrosis and idiopathic pulmonary fibrosis respectively.

Since 1998 LABOMAR and LABOMAR RESEARCH add innovation and technological excellence to your products. LABOMAR is particularly skilled in the manufacturing of Food Supplements, Medical Devices, Foods for Special Medical Purposes, Functional Foods and Cosmetics, most of them derived from internal development and based on innovative patented technologies. Labomar products are a guarantee of safety for Customers and End-users, in compliance with the principles of Good Manufacturing Practice and Quality. In this perspective, Labomar obtained three prestigious certifications: UNI EN ISO 9001:2008, CEI UNI EN ISO 13485:2012 and GMP (Code of Federal Regulation, Title 21, Volume 2, part 111). Visit our website www.labomar.com

Lo.Li. Pharma INTERNATIONAL is a branch of Lo.Li. Pharma Srl, a growing pharmaceutical company, based in Rome, dedicated to the research, development and out-licencing distribution of Medical Devices and Functional Dietary Supplements. The company's key success factor is the continuous effort in developing new products while responding to the needs of patients and of new treatments and prevention tools for the medical class. The innovative formulations of Lo.Li. Pharma have attracted the attention of many foreign Companies and private citizens alike, all looking forward to have Loli's products available in their own countries. With more than 20 products in our portfolio and our brand presented in more than 50 countries, we are always seeking out-licensing opportunities with key strategic partners for long term exclusive distribution. For further information, kindly contact us at info@lolipharmainternational.com or call +39 06.88379670

The Menarini Group is a leading international pharmaceutical and diagnostics company, present in 140 countries worldwide, with a turnover of €4,155 million and more than 17,000 employees. With 9 centers for Research & Development, Menarini’s products are present in the most important therapeutic areas, including cardiology, oncology, gastroenterology, pneumology, infectious diseases, diabetes, and anti-inflammatory/analgesics. The Group’s pharmaceutical production is carried out in its 18 manufacturing plants, which produce over 578 million packets of product a year and distribute them to five continents. Menarini’s pharmaceutical production, in line with the highest quality standards, provides an ongoing contribution to the health of patients all over the world.

At Microbion, we are developing a new class of therapeutic drugs to tackle the unmet needs of rare, chronic, and serious diseases. Our lead drug candidate, pravibismane, is a first-in-class therapeutic with a novel triad of activities: anti-infective, antibiofilm, and anti-inflammatory. These synergistic properties uniquely position pravibismane to address conditions where conventional treatments often fail. We are advancing multiple pravibismane formulations through clinical development, focusing on indications with significant unmet needs: - Topical pravibismane for diabetic foot ulcers/infections: Phase 3 studies planned for 2025 - Local/surgical pravibismane for orthopedic infections: Phase 2a studies completed - Inhaled pravibismane for pulmonary diseases including Nontuberculous mycobacteria lung infections: Ready for first-in-human Phase 1 studies Pravibismane has been granted FDA Qualified Infectious Disease Product (QIDP), Fast Track, and Orphan Drug designations, underscoring its disruptive potential. To date, pravibismane development has been supported by over $22M in grants awarded from leading organizations, including the U.S. Department of Defense, NIH, CARB-X, and the Cystic Fibrosis Foundation. We are actively seeking strategic licensing and development partners to advance Phase 3 trials, explore new indications (e.g., immunomodulation and inflammation), and bring pravibismane to patients worldwide.

Nerviano Medical Sciences S.r.l. (NMS Srl) focuses on discovering and clinically developing small molecule NCEs for oncology, aiming to deliver first- and best-in-class personalized cancer treatments through innovative mechanisms and novel drug targets. Our pipeline, built from our validated kinase platform, includes projects from early preclinical to clinical stages, advanced both internally and in partnership.  NMS Srl combines biotech agility with big pharma quality, guided by an experienced management team and a skilled staff with global expertise in research, drug discovery, and clinical development. Our capabilities are extended by NMS Group affiliates Accelera (AdMet) and NerPharMa (manufacturing), covering the entire drug development process. A core strength lies in our renowned kinase inhibitor platform, featuring an extensive chemical library and IP coverage, which has led to successful out-licensing deals, including with encorafenib and entrectinib. Additionally, we are advancing a PARP-family-focused platform to discover NCEs targeting NAD-binding pockets, with potential expansion to other NAD-dependent enzymes. Our growing payload-linker platform further enhances our pipeline by enabling next-generation ADC production. Collaborating globally with academic, clinical, and industry partners, we seek further strategic alliances to develop, commercialize, and expand our product portfolio while exploring in-licensing opportunities for promising clinical assets.

Newron is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain. We are committed to delivering innovative treatments to improve the quality of life for patients with CNS disorders. Our team has built a balanced and robust pipeline comprised of drug candidates at different clinical stages and has a proven track record of drug development and commercialization. Xadago® (safinamide) has received marketing authorization for the treatment of Parkinson’s disease in the European Union and Switzerland (both 2015) as well as in the U.S. (2017) and is commercialized in Europe by Newron’s Partner Zambon. Supernus Pharmaceuticals holds the commercialization rights in the US. Valeo Pharma holds the commercialization rights for the Canadian market, Seqirus for Australia & New Zealand, and Medison for Israel. Meiji Seika, in collaboration with Eisai, has the rights to develop and commercialize the compound in Japan and other key Asian territories. In addition to Xadago® for Parkinson’s disease, Newron has a strong pipeline of promising treatments including Evenamide as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia and ralfinamide for patients with specific rare pain indications. Founded in 1999, Newron is headquartered in Bresso, near Milan, Italy, with a subsidiary in Morristown, NJ, USA. The Company is listed on the SIX Swiss Exchange, under the trading symbol NWRN, on the primary market of the Düsseldorf Stock Exchange and on XETRA, trading symbol NP5.

Philogen is a Swiss-Italian integrated biotechnology company founded in 1996, with the mission to develop innovative biopharmaceuticals for the treatment of angiogenesis-related disorders. Angiogenesis, i.e. the formation of new blood vessels, is a characteristic feature of many severe pathologies such as cancer, rheumatoid arthritis and age-related macular degeneration. The company has been a pioneer in the isolation, engineering and clinical development of lead products capable of targeting angiogenesis in-vivo and has been the first in the world to demonstrate that human monoclonal antibodies, specific for a marker of angiogenesis, can efficiently and selectively target the tumor neo-vasculature both in animal models and in cancer patients. At present, Philogen has four promising anti-cancer antibody derivatives and an antibody derivative for the treatment of rheumatoid arthritis in clinical studies. Two registrational studies are in planning. Our Zurich-based daughter company Philochem serving as the R&D unit isolates the most promising candidate products, while in Siena (Italy) the pharmaceuticals are produced according to GMP standards and advanced to clinical trials. Philogen generates revenue from a diversified range of activities, has signed agreements with major pharmaceutical companies and owns a diversified portfolio of international patents.

WHO WE ARE PQE Group is a women-owned Contract Quality Organisation and Complete Quality Solution provider for GCP, GLP, GMP, GVP & GDP areas in the Life Science Industry. As an international group of over 2000 employees (40% of whom are female), we are composed of 43 nationalities and have experience working in more than 25 languages. PQE Group has an excellent history of supporting companies of all sizes and exceeding compliance standards from our 40 global offices. We are dedicated to creating value for our customers by putting our multidisciplinary teams and knowledge at their service, allowing our clients to achieve and maintain compliance with the latest regulations, and contributing to creating a safer pharmaceutical environment. WHAT WE DO Since 1998, PQE Group has successfully completed more than 15,000 projects worldwide while serving our 1400+ medical device and pharmaceutical clients. We deliver turnkey quality solutions while focusing on offering exceptional cost-effectiveness and maintaining the highest quality of care for our customers. With our extensive experience, effective project management, and exceptional cost-effectiveness, PQE's solutions are proven to be the winning combination for global corporations of all sizes. WHERE WE'RE GOING We at PQE Group strongly believe that our success is tied to the well-being of the communities and environment around us. We understand that change must come from ourselves first – so we take action through social responsibility goals like sustainable development, gender equality, protection of the environment, and health and safety. PQE Group actively works to achieve our ambitious objectives to foster social change and environmental stability by collaborating with important programs and charity associations around the world.

Recordati has been at the forefront of life-enhancing and life-changing medicines for almost 100 years. With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical force, listed on the Italian stock exchange, with over 4,300 employees. We are a group of like-minded, passionate individuals who go to extraordinary lengths for our partners, customers, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries. At Recordati, our mantra is simple. We’ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves. This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases. Recordati. Unlocking the full potential of life.

Resalis Therapeutics’ transformative metabolic disease approach targets a master regulator of key pathways underlying obesity and fatty liver disease. The company is applying its unique understanding of the non-coding RNA drug modality and lipid metabolism to develop its lead program, RES-010, into a safe and convenient treatment providing disease-modifying therapeutic impact including durable weight loss and reduction of hepatic steatosis. Building on robust preclinical evidence, Resalis will rapidly bring RES-010 into clinical trials for a range of metabolic disorders.

Discovering and developing novel drugs has been our passion, work and mission for over 50 years. Rottapharm Biotech lives for innovation and innovation lives at Rottapharm Biotech. This is all we are and all we want to be.

Sibylla is an innovative start-up founded in 2017 as a spin-OFF of the INFN (National Institute of Nuclear Physics) and the Trento and Perugia Universities. Its multidisciplinary team of co-founders has developed a pioneering Early Drug Discovery method that applies to the research and design of new drugs, effective against diseases so far incurable. Drug discovery is an extremely complex problem, therefore requiring innovation. Sibylla is a beautiful example of how innovation can be pushed forward by a multidisciplinary and agile team. Sibylla's approach is based on the possibility of simulating the folding pathway from the amino acid sequence as produced by the cells' ribosomes to the native state. Traditional pharmacological methods investigate the target proteins' interaction sites in their native, biologically active state. Novel methods act at the DNA level. Sibylla follows an alternative approach. We identify small molecules that bind to pockets found in the intermediate folding state. These pockets disappear in the native state, and that is why we may try to drug proteins which have been so far considered undruggable. Sibylla technology is called PPI-FIT (Pharmacological Protein Inactivation by Folding Intermediate Targeting). A molecule found through PPI-FIT would impair the folding of the protein, leading it to degradation. The overall effect is a selective reduction of the expression level of the target protein. The medical areas focused on by Sibylla's research include oncology and antibiotic resistance, although the technology can be applied to any therapeutic area. The company is developing a proprietary pipeline of potential drugs. We can also provide co-development or identifying potential drugs for pharmaceutical companies' specific targets. We recently signed a collaboration agreement with an important Pharma company. Besides the promising results already achieved, Sibylla keeps being engaged in developing proprietary computing technology.

ViroStatics srl is a privately held bio-pharmaceutical company, headquartered in Sassari (Italy), with a successful history of fundraising and a large international network of partners and collaborators. Management has track record in Licensing and M&As. Its key operational field is oncology. Over the years, ViroStatics has developed a robust pipeline of proprietary compounds for several distinct disease indications (with initial focus on Breast cancer resistant to CDK4/6 inhibitors and Mesothelioma), all of them covered by patent protection towards 2039, characterized by their unique kinase selectivity, efficacy and safety profiles. ViroStatics is also still active in virology offering services to test drugs and devices against SARS-CoV-2. The company is led by a top-level team, with experience in the conduction of complex projects. Its expertise spans from basic science to clinical trials with over 100 published manuscripts and over 10 clinical trials coordinated (Phase I and Phase II). http://www.virostatics.com/

Zambon is a modern healthcare company founded on the history and values of an Italian family and committed to innovating cure & care to improve patients’ lives. Zambon is present in three different Continents – Europe, America and Asia – with manufacturing units in Italy, Switzerland, France, China and Brazil. Zambon SpA, the pharma subsidiary of the group with its 23 branches, has taken a new role in the industry. In addition to pain and diseases of the respiratory system and urological system, Zambon is establishing a global pipeline and introducing important treatments for serious diseases such as Parkinson’s Disease, Cystic Fibrosis, BOS and NCFB. In recent years, ZBiotech, a specialized biotech company that aims to build a scientifically robust and commercially viable portfolio of innovative patient-oriented drugs through through the scouting, acquisition, licensing and development of new molecules, has also been established. Zambon produces high quality products thanks to the management of the whole production chain which involves Zach-Zambon Chemicals, a privileged partner for API, custom synthesis and generic products. Zambon complements the offering of medicines with modern health solutions, in order to translate its Vision into concrete actions. Zcube - Zambon Research Venture - is actively scouting for modern health solutions in the field of drug delivery systems, medical devices, biomarkers, diagnostics, digital health and big data solutions. In 2018 Zcube established Careapt, a new start-up which develops integrated Hi-Tech/Hi-Touch solutions for chronic disease management. The group also includes ItaliAssistenza, a Home Care Company involved in Patient Support Programs and home care. Zambon was established in 1906 in Vicenza and is headquartered in Milan within OpenZone, the scientific campus where knowledge is shared between partners in the field of Healthcare, founded with the aim to transform research into enterprise.