Ambros Therapeutics’ non-opioid bisphosphonate analgesic, already approved in Italy, will soon begin a pivotal test in the U.S.
New pain biotech Ambros Therapeutic launched Tuesday with a $125 million series A raise and plans to move straight into Phase III to start the new year.
Ambros is developing neridronate, a non-opioid pain medicine developed by Italy’s Abiogen Pharma that’s already approved in that market. Ambros is seeking to bring neridronate stateside, armed with a trio of FDA designations to advance development swiftly, according to the company’s announcement.
Neridronate belongs to a class of drugs targeting bisphosphonate, which is believed to have a role in preventing soft tissue calcification and in regulating bone mineralization.
The $125 million in funding, backed by RA Capital Management and Patient Square Capital’s platform Enavate Sciences, will support a Phase III trial for the drug in complex regional pain syndrome type 1 (CRPS-1), a chronic pain condition that occurs after injury when no nerve damage is present. In addition to CRPS-1, neridronate is approved in Italy for osteogenesis imperfecta and Paget’s disease. The therapy is not currently approved elsewhere for the condition.
But that could change with the emergence of Ambros. The FDA has already granted neridronate breakthrough therapy, fast track and orphan drug tags for CRPS-1, the company said. Ambros licensed the therapy from Abiogen; details of that transaction were not provided.
Ambros will be helmed by Jay Hagan, the former CEO of Regulus Therapeutics, which was bought by Novartis in May for $1.7 billion. Other notable names attached to the new biotech include Vivek Ramaswamy, the founder of Roivant Sciences who went on to run for president before later endorsing President Donald Trump.
Pain has increasingly come into focus in biopharma, particularly non-addictive options in the wake of the opioid crisis. Vertex earned approval for the non-opioid painkiller Journavx in January 2025.
Other biopharmas in the space include Eli Lilly, Lexicon Therapeutics and Sangamo Therapeutics.