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15.01.2026
2025 was a turning point. Continuous cough monitoring moved from an experimental tool to a scalable service. The field stopped asking "can we measure cough?" and started asking "what do we do with all this data?" That shift changes everything.
Here's where I think we're headed in 2026.
Cough-omics was the field’s word of the year in 2025. It connotes the idea that cough is a rich, quantifiable biological signal, not just a symptom to suppress. Continuous monitoring makes this possible. The major finding from last year was that daily cough counts vary enormously within individuals making 24 hour measurements unreliable measures of cough burden. That has huge implications for trial design. In 2026, I expect multi-day monitoring to become the default for any serious cough endpoint work yielding novel insights into its biology and treatment.
After years of setbacks, the pipeline is finally maturing. Camlipixant showed real promise in Phase 2. Nalbuphine demonstrated meaningful cough reduction with manageable side effects. Gefapixant stumbled at FDA but got approved in parts of Asia, which means the regulatory path isn't closed, it just needs better data. The bar is clearer now than it's ever been. The data generated in 2025 suggests that a drug could be approved as early as late 2026 supported by a robust pipeline of other drugs.
Cough monitoring has focused heavily on refractory chronic cough because that's the obvious endpoint in antitussive drug development. But the technology doesn't care about indication. In 2025, we saw cough emerge as a meaningful signal in COPD, IPF, bronchiectasis, asthma and even heart failure. Look for 2026 to be the year this spreads, not just as an endpoint, but as a way to stratify patients, predict exacerbations, and support marketing claims. If you're developing a respiratory drug and you're not measuring cough, you're leaving data on the table.
Behavioral cough suppression therapy works—we've known that for years. The problem has been access. There are fewer than 200 speech-language pathologists in the US trained to deliver it. That's why the push is on to digitize and scale these interventions. In 2025, we published proof-of-concept data showing a 41% reduction in cough frequency using a digital version of BCST. Kyorin is developing a prescription digital therapeutic for the Japanese market. In 2026, expect more rigorous trials, more regulatory conversations, and the beginning of real-world deployment of toxiciy free cough treatment that targets the brain—either standalone or in combination with new drugs.
There's no FDA-cleared cough counter on the market. The one device that's been used in trials drew pointed criticism from regulators. That's created an opening. In 2026, I expect multiple pharma companies to have direct conversations with CDER about continuous cough monitoring as an endpoint. We're already part of several of those discussions. The more sponsors who engage, the clearer the path becomes for everyone. This is the year the regulatory fog starts to lift.
The science is settled: refractory chronic cough is a neurogenic hypersensitivity disorder, not just a symptom of something else. That consensus emerged clearly at CHEST, ERS, and the American Cough Conference in 2025. But most of the clinicians who actually see these patients—primary care, pulmonology, ENT, allergy—haven't gotten the memo yet. The challenge in 2026 is dissemination. The specialists are aligned. Now we need to reach the enormous number of providers who are still treating cough as a nuisance rather than a condition.
2025 proved that cough can be measured with the same rigor we apply to any other vital signs. 2026 is the year that capability becomes expected - in trials, in clinics, and in how we think about respiratory disease.
Peter Small, MD Chief Medical Officer, Hyfe
