This is the weekly update in respiratory therapy, summarizing the latest clinical and regulatory developments, data releases, and relevant partnerships. This update highlights key advancements and emerging trends in the field.

In Today’s Newsletter

Dive deeper

🧪 Trevi Therapeutics Publishes Phase 2b Results for Nalbuphine ER in IPF Chronic Cough [22 Jan 2026]

https://ir.trevitherapeutics.com/2026-01-22-Trevi-Therapeutics-Announces-Publication-of-Data-from-the-Phase-2b-IPF-Chronic-Cough-Trial-of-nalbuphine-ER-in-the-Journal-of-the-American-Medical-Association-JAMA
Context: Positive Phase 2b results published in JAMA for nalbuphine ER show significant reduction in chronic cough for IPF patients.
Key point: Over 60% of patients treated with nalbuphine ER experienced a 50% or greater reduction in cough frequency.
Implication: These results may pave the way for a new treatment option for chronic cough in IPF patients.

💨 Trelegy Ellipta Approved in China for Asthma [China • 23 Jan 2026]

https://www.gsk.com/en-gb/media/press-releases/trelegy-ellipta-approved-in-china/
Context: GSK announces approval of Trelegy Ellipta in China for asthma, expanding its current indication for COPD.
Key point: Trelegy Ellipta is the only single inhaler triple therapy approved for both asthma and COPD in China.
Implication: This approval will improve access to an effective treatment for the 46 million adults with asthma in China, especially those with uncontrolled symptoms.

🦠 Traws Pharma Completes Enrollment in Ratutrelvir Study for COVID-19 [26 Jan 2026]

https://www.trawspharma.com/press-release-single?id=traws-pharma-completes-enrollment-of-ratutrelvir-clinical-study-in-paxlovid-r-eligible-and-ineligible-covid-19-patients-announces-plans-for-added-indication-for-tivoxavir-marboxil-as-a-prophylactic-treatment-for-seasonal-influenz
Context: Traws Pharma completes enrollment in its Phase 2 study of ratutrelvir, an investigational treatment for COVID-19.
Key point: Ratutrelvir shows potential for fewer adverse events and faster symptom resolution compared to PAXLOVID®.
Implication: If successful, this could offer a promising new treatment for both eligible and ineligible COVID-19 patients.

💉 NICE Approves Dupilumab for COPD in the UK [UK • 26 Jan 2026]

https://www.nice.org.uk/news/articles/new-hope-for-people-with-breathing-condition-copd-as-nice-approves-innovative-treatment
Context: NICE recommends dupilumab as a new treatment for COPD patients in the UK.
Key point: Dupilumab has shown to reduce flare-ups by 30% in clinical trials, offering an effective, self-administered biologic option for patients.
Implication: This approval could significantly reduce hospital admissions and improve quality of life for patients with uncontrolled COPD.

💊 Transpire Bio’s Generic Trelegy Ellipta Accepted for Filing by the U.S. FDA [US • 27 Jan 2026]

https://www.transpirebio.com/transpire-bio-anda-for-generic-trelegy-ellipta-accepted-for-filing-by-the-us-fda/
Context: Transpire Bio’s ANDA for a generic version of Trelegy Ellipta has been accepted by the U.S. FDA.
Key point: This could provide an affordable alternative for patients with asthma and COPD.
Implication: The potential for market exclusivity may help expand access to treatment in the U.S. for asthma and COPD patients.

🌬 Nuance Pharma’s Ohtuvayre® NDA Accepted in China [China • 27 Jan 2026]

https://en.prnasia.com/releases/apac/nuance-pharma-announces-acceptance-for-review-of-the-new-drug-application-for-ohtuvayre-ensifentrine-by-the-national-medical-products-administration-of-china-for-the-maintenance-treatment-of-chronic-obstructive-pulmonary-disease-520315.shtml
Context: Nuance Pharma’s NDA for Ohtuvayre® (ensifentrine) has been accepted for review in China. Key point: Ohtuvayre® is a dual-action inhaled therapy targeting both bronchodilation and inflammation.
Implication: This marks a significant step forward in the treatment of COPD, offering a novel treatment option for Chinese patients.

🧬 Clarametyx Strengthens SAB to Advance Biofilm Technologies [27 Jan 2026]

https://clarametyx.com/clarametyx-biosciences-strengthens-scientific-advisory-board-with-expert-appointments-to-advance-pipeline-programs/
Context: Clarametyx Biosciences appoints new experts to its Scientific Advisory Board to accelerate development of anti-biofilm therapies.
Key point: The appointments come after successful Phase 2a data for CMTX-101, a promising therapy for cystic fibrosis-related infections.
Implication: With this strengthened advisory team, Clarametyx is poised to advance its promising therapies for chronic respiratory diseases.

💰 Savara Secures $75M Debt Facility to Support MOLBREEVI Launch [27 Jan 2026]

https://investors.savarapharma.com/news/news-details/2026/Savara-Announces-Amendment-to-Hercules-Capital-Debt-Facility-Providing-up-to-75M-of-Additional-Debt-Funding-Upon-U-S–Food-and-Drug-Administration-FDA-Approval-of-MOLBREEVI/default.asp
Context: Savara announces an amended loan agreement with Hercules Capital to secure additional funding for MOLBREEVI’s launch.
Key point: The $75M in debt funding, combined with previous royalty financing, gives Savara approximately $150M for the MOLBREEVI launch.
Implication: These funds will support the potential approval and commercialization of MOLBREEVI, a therapy for autoimmune pulmonary alveolar proteinosis.

🔬 GRI Bio Shows Phase 2a Data for GRI-0621 in IPF [28 Jan 2026]

https://gribio.com/gri-bio-delivers-compelling-new-phase-2a-gene-expression-data-demonstrating-improvements-in-key-drivers-of-fibrosis-and-lung-repair-in-ipf/
Context: GRI Bio presents new gene expression data from its Phase 2a study of GRI-0621 in IPF patients.
Key point: GRI-0621 demonstrated significant effects on lung repair and fibrosis regression.
Implication: GRI-0621 could represent a novel disease-modifying treatment for IPF, potentially offering patients long-term improvements in lung function.

📊 Insmed Presents TPIP Data at PVRI 2026 Congress [28 Jan 2026]

https://investor.insmed.com/2026-01-28-Insmed-to-Present-Multiple-Abstracts-on-Treprostinil-Palmitil-Inhalation-Powder-TPIP-at-Pulmonary-Vascular-Research-Institute-PVRI-2026-Congress
Context: Insmed presents multiple abstracts on TPIP, an inhalation powder for pulmonary arterial hypertension (PAH), at PVRI 2026.
Key point: Data include Phase 2b results and a new analysis on pulmonary vasodilation in rat models.
Implication: This data may provide further insights into TPIP’s potential as a treatment for PAH, setting the stage for Phase 3 trials.

Why it matters

  • Trevi’s Phase 2b results offer new hope for treating chronic cough in IPF, a condition with no FDA-approved therapies.
  • GSK’s Trelegy approval in China provides a much-needed treatment option for asthma patients.
  • Traws Pharma’s ratutrelvir trial could provide a much-needed alternative to existing COVID-19 treatments.
  • Dupilumab’s NICE approval in the UK represents a significant milestone for COPD management, improving patients’ quality of life.
  • Nuance Pharma’s Ohtuvayre® could change the landscape of COPD treatment in China, providing a dual-action therapy.
  • Clarametyx’s anti-biofilm technology shows promise in addressing chronic respiratory diseases like cystic fibrosis.
  • Savara’s funding ensures the timely launch of MOLBREEVI, addressing a major unmet need in autoimmune PAP.
  • GRI Bio’s GRI-0621 might offer a disease-modifying treatment for IPF, providing a new avenue for long-term lung repair.
  • Insmed’s TPIP presentations at PVRI provide valuable clinical insights as they move towards Phase 3 trials for PAH.

🚀 Accelerate your success. Contact us now

📂 Explore our case studies. See examples of our work.

💡 Read our insights. Learn from our latest reports and analysis

🎬 Watch on YouTube. Subscribe and never miss a video.

🧰 See our full range of servicesDiscover how we can help you.

📚 See the full Respiratory archive on our research hub page

FAQ

What did Trevi Therapeutics’ Phase 2b study show for chronic cough in IPF?

The Phase 2b study demonstrated that nalbuphine ER significantly reduced chronic cough in IPF patients, with more than 60% of treated patients achieving a ≥50% reduction in cough frequency, supporting its potential as a first targeted therapy for this unmet need.

Why is Trelegy Ellipta’s approval in China significant for asthma patients?

Trelegy Ellipta became the first and only single-inhaler triple therapy approved in China for both asthma and COPD, expanding treatment options for patients with uncontrolled asthma and improving access for millions of adults.

What differentiates ratutrelvir from existing COVID-19 antivirals?

Ratutrelvir showed potential for fewer adverse events and faster symptom resolution compared with PAXLOVID®, and is being developed for both PAXLOVID®-eligible and -ineligible patients, addressing gaps in current COVID-19 treatment options.

What is notable about NICE’s approval of dupilumab for COPD?

Dupilumab is one of the first biologics approved for COPD, reducing flare-ups by 30% in trials and offering a self-administered option that could lower hospitalizations and improve quality of life for patients with uncontrolled disease.

Why does the FDA acceptance of a generic Trelegy Ellipta matter?

The FDA’s acceptance of Transpire Bio’s ANDA could pave the way for a lower-cost alternative to Trelegy Ellipta, potentially improving affordability and access for asthma and COPD patients in the U.S.

What is novel about Ohtuvayre® (ensifentrine) for COPD?

Ohtuvayre® is a dual-action inhaled therapy combining bronchodilation and anti-inflammatory effects, representing a new mechanistic approach to COPD maintenance treatment as it undergoes regulatory review in China.

How could GRI-0621 change the treatment landscape for IPF?

GRI-0621 showed gene expression changes consistent with fibrosis regression and lung repair in Phase 2a data, suggesting it may function as a disease-modifying therapy rather than solely managing symptoms.

What is the importance of Insmed’s TPIP data presented at PVRI 2026?

The TPIP data included Phase 2b and preclinical findings supporting pulmonary vasodilation in PAH, strengthening the clinical rationale for advancing this inhaled therapy toward Phase 3 development.

Entities / Keywords

Trevi Therapeutics, nalbuphine ER, GSK, Trelegy Ellipta, Traws Pharma, ratutrelvir, NICE, dupilumab, Transpire Bio, Ohtuvayre®, Nuance Pharma, Clarametyx Biosciences, anti-biofilm, Savara, MOLBREEVI, GRI Bio, GRI-0621, Insmed, TPIP, pulmonary arterial hypertension (PAH), idiopathic pulmonary fibrosis (IPF), chronic obstructive pulmonary disease (COPD).

References

  1. https://ir.trevitherapeutics.com/2026-01-22-Trevi-Therapeutics-Announces-Publication-of-Data-from-the-Phase-2b-IPF-Chronic-Cough-Trial-of-nalbuphine-ER-in-the-Journal-of-the-American-Medical-Association-JAMA
  2. https://www.gsk.com/en-gb/media/press-releases/trelegy-ellipta-approved-in-china/
  3. https://www.trawspharma.com/press-release-single?id=traws-pharma-completes-enrollment-of-ratutrelvir-clinical-study-in-paxlovid-r-eligible-and-ineligible-covid-19-patients-announces-plans-for-added-indication-for-tivoxavir-marboxil-as-a-prophylactic-treatment-for-seasonal-influenza
  4. https://www.nice.org.uk/news/articles/new-hope-for-people-with-breathing-condition-copd-as-nice-approves-innovative-treatment
  5. https://www.transpirebio.com/transpire-bio-anda-for-generic-trelegy-ellipta-accepted-for-filing-by-the-us-fda/
  6. https://en.prnasia.com/releases/apac/nuance-pharma-announces-acceptance-for-review-of-the-new-drug-application-for-ohtuvayre-ensifentrine-by-the-national-medical-products-administration-of-china-for-the-maintenance-treatment-of-chronic-obstructive-pulmonary-disease-520315.shtml
  7. https://clarametyx.com/clarametyx-biosciences-strengthens-scientific-advisory-board-with-expert-appointments-to-advance-pipeline-programs/
  8. https://investors.savarapharma.com/news/news-details/2026/Savara-Announces-Amendment-to-Hercules-Capital-Debt-Facility-Providing-up-to-75M-of-Additional-Debt-Funding-Upon-U-S–Food-and-Drug-Administration-FDA-Approval-of-MOLBREEVI/default.aspx
  9. https://gribio.com/gri-bio-delivers-compelling-new-phase-2a-gene-expression-data-demonstrating-improvements-in-key-drivers-of-fibrosis-and-lung-repair-in-ipf/
  10. https://investor.insmed.com/2026-01-28-Insmed-to-Present-Multiple-Abstracts-on-Treprostinil-Palmitil-Inhalation-Powder-TPIP-at-Pulmonary-Vascular-Research-Institute-PVRI-2026-Congress

Privacy Preference Center