Forging New Pathways for Patients with Severe Pulmonary Diseases
Every Medical Advance Begins with Patients
At IRulya, we are investigating LAM-001 across multiple severe pulmonary diseases where treatment options remain limited and where the underlying disease biology has historically been difficult to address. By targeting a dysfunctional biological pathway and delivering treatment directly to the lungs, we aim to advance a novel approach that offers new possibilities for patients with serious unmet medical needs.
Our Trials
We are deeply thankful to the patients who choose to participate in our clinical trials. Their courage, commitment, and partnership drive every step of the drug development process.
Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)
Study to Evaluate the Efficacy and Safety of Once Daily LAM-001 (Inhaled Sirolimus) for the Treatment of Pulmonary Hypertension and Interstitial Lung Disease.
Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)
Study to Evaluate the Efficacy and Safety of Once Daily LAM-001 (Inhaled Sirolimus) for the Treatment of Pulmonary Hypertension and Interstitial Lung Disease.
Trial Status
- Recruiting
- Phase 2
- Multiple US locations available
Key Participation Criteria*
- Diagnosis of PH WHO Group 3 associated with ILD in accordance with ESC/ERS Guidelines (Humbert 2022). Diagnosis will be confirmed by CT imaging showing diffuse parenchymal disease
- Confirmed pulmonary hypertension (PH) by right heart catheterization
- 6-minute walking distance ≥100
- WHO functional class II or III symptomatology
* Additional study criteria may apply
STATUS: Recruiting
Full Study Details >
Sarcoidosis Associated Pulmonary Hypertension (SAPH)
Study to Evaluate the Efficacy and Safety of Once Daily LAM-001 (Inhaled Sirolimus) for the Treatment of Sarcoidosis Associated Pulmonary Hypertension.
Sarcoidosis Associated Pulmonary Hypertension (SAPH)
Study to Evaluate the Efficacy and Safety of Once Daily LAM-001 (Inhaled Sirolimus) for the Treatment of Sarcoidosis Associated Pulmonary Hypertension.
Trial Status
- Not yet recruiting
- Phase 2
Key Participation Criteria*
- Diagnosis of sarcoidosis based on ATS/WASOG criteria
- Confirmed pulmonary hypertension (PH) by right heart catheterization
- High Resolution CT (HRCT) during screening or up to 6 months prior
- 6-minute walking distance ≥100 and ≤450 meters
- WHO functional class II or III symptomatology
* Additional study criteria may apply
STATUS: Not yet recruiting
Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome (BOS)
Study to Evaluate the Efficacy and Safety of Once Daily LAM-001 (Inhaled Sirolimus) for the Treatment of Bronchiolitis Obliterans Syndrome Post Lung Transplant.
Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome (BOS)
Study to Evaluate the Efficacy and Safety of Once Daily LAM-001 (Inhaled Sirolimus) for the Treatment of Bronchiolitis Obliterans Syndrome Post Lung Transplant.
Trial Status
- Recruiting
- Phase 2
- Single Site: University of California, San Francisco
Key Participation Criteria*
- Age greater than 18 years
- Recipient of double pulmonary allograft at least 12 months prior to study entry
- Confirmed BOS defined as screening FEV1 between 51-81% of baseline and FEV1 decline sustained for greater than 30 days
- On standard immunosuppression consisting of 3 medications
* Additional study criteria may apply
STATUS: Expansion Phase recruiting
Full Study Details >
Investigator-sponsored clinical trial
Why LAM-001?
Although PH-ILD, BOS, and SAPH are distinct diseases, a hyperactive mTOR pathway plays a role in the underlying pathophysiology of each condition. When overactivated, the mTOR pathway fuels the proliferative behavior of smooth‑muscle cells, endothelial cells, fibroblasts, and immune cells. By dampening this signaling, LAM-001 has the potential to exert disease modifying anti‑proliferative, anti-fibrotic, and immunomodulatory effects. These properties form the biological rationale for exploring mTOR inhibition across pulmonary indications where unchecked cellular growth, inflammation, and tissue-remodeling contribute to disease progression.