Correct.
But since it's been found to be effective in treating Raynaud's (20% of adults have this, pain/numbness in fingers or toes, especially when exposed to cold), the company that developed it got special protection. from the FDA guaranteeing 7 years of exclusivity once it's fully approved.
Good news for the US and EU.
The FDA has granted orphan drug designation to AISA-021, a fourth-generation calcium channel blocker, for the treatment of systemic sclerosis, according to a press release from Aisa Pharma.The drug is a form of cilnidipine, a dihydropyridine calcium channel blocker approved and used for the...
www.healio.com
Currently conducting clinical trials in phase 2 in Australia for Cildipidine combined with tadalafil also for treatment of Raynaud's. Moving on to US trials after this.
About the RECONNOITER Study Program (Randomized Evaluation of the benefit of Cilnidipine ON the Nature, Observational Indices, Temperature changes and overall Effect in scleroderma and Raynaud’s Disease) The RECONNOITER Study is a 76 patient prospective, double-blind, randomized Phase 2A trial...
aisapharma.com
The statement "long standing drug with a good safety profile" is commonly found in reference to Cildipidine.
There's a ton of data out there on humans, much of it from real world use via retrospective medical record reviews because this is a well established medicine that some patients have been using for decades.