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HFA Modulite techn

✓ Approved

Chiesi Farmaceutici S.p.A. · therapeutic agent

What is HFA Modulite techn?

HFA Modulite techn is a therapeutic agent developed by Chiesi Farmaceutici S.p.A.. It is approved for therapeutic indications via inhaled.

Drug Profile

CompanyChiesi Farmaceutici S.p.A.
RouteInhaled
StatusApproved
Sources: ClinicalTrials.gov, Chiesi Farmaceutici S.p.A.

Therapeutic Indications

HFA Modulite techn is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Surgical and medical proceduresOral appliance application✓ Approved

Related Research Articles

PubMedJournal of aerosol medicine and pulmonary drug delivery2026-07-16

Toward Next-Generation Propellants: Assessing Lung Deposition of Beclometasone Dipropionate, Formoterol, and Glycopyrrolate Formulated with HFA-152a Using Functional Respiratory Imaging.

Matturro Angelo A, Monshi Tousi Navid N, Sadafi Hosein H, Cuoghi Erika E et al.

Pressurized metered-dose inhalers (pMDIs) rely on hydrofluoroalkane (HFA) propellants that have a high global warming potential (GWP). Reformulation with next-generation, low-GWP propellants, such as HFA-152a, offers a strategy to reduce climate impact; however, changes in propellant composition can affect aerosol characteristics and potentially alter lung deposition, requiring robust demonstration of therapeutic equivalence. Functional respiratory imaging, combining high-resolution computed tomography and computational fluid dynamics, was used to compare the lung deposition of a fixed triple combination of beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide (BDP/FF/GB) delivered via a pMDI formulated with either HFA-134a (Reference) or HFA-152a (Test). Ten patients with chronic obstructive pulmonary disease (GOLD stages 2-4) were retrospectively selected. Patient-specific airway geometries, a standardized inhalation profile, and formulation-specific particle size distributions and plume characteristics were applied. Deposition was quantified in the intrathoracic, central + distal, and peripheral lung regions, and the (central + distal)/peripheral ([C + D]/P) deposition ratio was evaluated. Mean intrathoracic deposition was comparable between the Reference and Test formulations, ranging from 45.95% to 46.88% of the delivered dose (DD). Deposition in the central + distal airways accounted for 12% of DD for both formulations, whereas peripheral deposition predominated, with 33.7% of DD for the Test formulation and 34.5% of DD for the Reference formulation. The (C + D)/P ratios were similar across all active components (0.35-0.37), indicating consistent preferential deposition in the peripheral/small airways. Although inter-patient variability was observed, intra-subject comparisons showed close agreement between propellants. Reformulation of the BDP/FF/GB pMDI with the low-GWP propellant HFA-152a preserved total and regional lung deposition characteristics relative to the current HFA-134a formulation. These findings support the maintenance of deposition performance while enabling a substantial reduction in environmental impact, reinforcing the potential of HFA-152a as a next-generation propellant for carbon minimal pMDI therapies.

PMID 42461266
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PubMedJournal of aerosol medicine and pulmonary drug delivery2026-07-16

Mucociliary Clearance Following a Next-Generation Propellant Versus Hydrofluoroalkane-134a via Pressurized Metered-Dose Inhaler: A Randomized, Double-Blind, Two-Way Crossover Study in Healthy Adults.

Donaldson Scott H SH, Zeman Kirby L KL, Bell Alan A, Jassal Mandeep M et al.

Pressurized metered-dose inhalers (pMDIs) are commonly used for respiratory disease treatment but contain propellants, such as hydrofluoroalkane-134a (HFA-134a), with global warming potential (GWP) that contribute to the climate emergency. To safeguard essential medicine access, it is crucial to transition to lower-GWP propellants, such as hydrofluoroolefin-1234ze (HFO-1234ze), which has 99% lower GWP than HFA-134a. In accordance with global regulatory requirements, this study was conducted to support the registration of pMDIs with HFO-1234ze. This randomized, double-blind, multicenter, two-way crossover study assessed the effects of HFO-1234ze versus HFA-134a on mucociliary clearance (MCC) in healthy participants aged 18-60 years. Participants received six inhalations twice daily of HFO-1234ze and HFA-134a in two 7-day (+3) intervention periods separated by a 7- to 14-day washout. The primary and secondary endpoints were change from period-specific baseline in average whole lung MCC (%) through 60 minutes (MCC60) and at 3 hours (MCC3h), respectively, measured via inhalation of 99mTc-labeled colloid and gamma camera imaging. Given significant baseline variability, a post hoc analysis of the primary endpoint assessed change from average baseline instead of period-specific baseline MCC60. Additional safety and tolerability measures were assessed. Forty-five participants were screened; the Primary Analysis Set included 34 participants who completed both intervention periods. For the primary endpoint, change from period-specific baseline in MCC60 was negligible, with an estimated change (95% confidence interval [CI]) of -0.6% (-3.2%, 1.9%) for HFO-1234ze and 0.8% (-1.7%, 3.3%) for HFA-134a. The estimated least-squares mean difference (95% CI) between HFO-1234ze and HFA-134a was -1.4% (-5.8%, 2.9%). For the secondary endpoint, the estimated least-squares mean difference for change from period-specific baseline in MCC3h between HFO-1234ze and HFA-134a was -5.7% (-10.9%, -0.5%). There were no unexpected safety findings. There was no clinically relevant impact of HFO-1234ze versus HFA-134a on MCC in healthy participants. NCT05755932.

PMID 42461285
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PubMedEuropean journal of heart failure2026-07-14

Cardiac myosin-binding protein C in community-based patients with suspected heart failure.

Docherty Kieran F KF, Petrie Mark C MC, McKinley Gemma G, Bear Greg G et al.

Myocardial injury is a hallmark of heart failure (HF). It is unknown whether established (e.g. troponin) or novel biomarkers of myocardial injury [e.g. cardiac myosin-binding protein C (cMyBP-C)] provide additive diagnostic value beyond natriuretic peptides in community patients with suspected HF. Community-based patients with suspected HF and elevated NT-proBNP levels were recruited into a multicentre, prospective, observational study at five sites (NCT04724200). Venous blood sampling was performed at the time of echocardiography. HF was classified according to left ventricular ejection fraction: HF with reduced ejection fraction (HFrEF) = ≤40%, HF with mildly reduced ejection (HFmrEF) = 41-49%, and HF with preserved ejection fraction (HFpEF) = ≥50% with HFA-PEFF score ≥5. NT-proBNP (Roche Elecsys® assay), high-sensitivity cardiac troponin T (hs-cTnT, Roche Elecsys® assay) and cMyBP-C (Roche precommercial assay) were measured. Diagnostic accuracy of each biomarker alone and in combination was examined using the area under the receiver operating characteristic curve (AUROC). Of 867 patients, 751 (87%) had measurable left ventricular ejection fraction and available biomarker data. Of these, 43 (6%) had HFrEF, 75 (10%) HFmrEF, and 278 (37%) HFpEF. NT-proBNP levels were highest in patients with HFrEF, with similar patterns observed for hsTnT and cMyBP-C. For the diagnosis of HF versus no HF, the combination of NT-proBNP and cMyBP-C had the highest AUROC of 0.77 (95%CI 0.73-0.80) versus NT-proBNP alone [0.74 (0.71-0.78); P = .003]. For detection of HFrEF versus no HF, the AUROC was 0.90 (0.86-0.95) for the combination of NT-proBNP and cMyBP-C compared with 0.85 (0.80-0.90) for NT-proBNP alone (P = .006). Measurement of cMyBP-C improved the diagnostic accuracy of NT-proBNP in community-based patients with suspected HF, with greatest additive value for identifying HFrEF, and may help in the prioritization of echocardiography.

PMID 42446895
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PubMedTranslational vision science & technology2026-07-13

Multicenter OCT-Based Visual Field Representations via Segmentation-Free 3D CNNs: Forecasting, Longitudinal Variability, and Progression Detection.

Koyama Makoto M, Takahashi Hidenori H, Inoda Satoru S, Mayama Chihiro C et al.

To evaluate segmentation-free three-dimensional convolutional neural networks (3DCNNs) that derive visual field (VF)-shaped representations from macular optical coherence tomography (OCT) volumes (OCT-based estimated VF; OCT-VF) and to assess their performance in forecasting future Humphrey field analyzer (HFA) measurements and characterizing longitudinal variability in clinical datasets. The 3DCNN models were trained on 129,007 heterogeneous real-world paired OCT-HFA datasets from 13,366 patients (24,313 eyes) across five institutions using 10-fold cross-validation. Forecasting accuracy for the last HFA visit was evaluated using HFA-only forecasts and hybrid models that combined HFA-anchored intercept with longitudinal slopes derived from both OCT-VF and HFA (AOS-AVG). Longitudinal variability was assessed as residual deviations from linear trends using jackknife resampling. The AOS-AVG yielded the lowest forecasting errors across endpoints and significantly reduced mean absolute error compared with HFA-only forecasts (pointwise thresholds: 24-2, 2.45 vs. 2.68 dB; 10-2, 2.44 vs. 2.65 dB; both P < 0.001). OCT-VF showed significantly lower residual variability than HFA (MD: 24-2, 0.79 vs. 1.13 dB; 10-2, 0.87 vs. 1.07 dB; both P < 0.001). Eyes classified as progression-positive by OCT-VF but negative by HFA exhibited greater perimetric variability and steeper HFA MD decline than true-negative eyes. Hybrid forecasting approaches that incorporate OCT-VF-derived slope information can improve prediction of future visual-field outcomes. The lower variability of OCT-VF representations may also enable detection of progression-related signals that remain obscured by perimetric noise in routine longitudinal monitoring. OCT-VF may serve as a complementary tool for precision disease monitoring alongside current automated perimetry.

PMID 42439428
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PubMedJournal of arrhythmia2026-07-13

Utility of Post-Procedural HFA-PEFF Reassessment for Long-Term Heart Failure Risk Stratification After Atrial Fibrillation Ablation.

Ishiguchi Hironori H, Yoshiga Yasuhiro Y, Fukuda Masakazu M, Hashimoto Shintaro S et al.

The utility of post-procedural HFA-PEFF reassessment for long-term heart failure (HF) risk stratification after atrial fibrillation (AF) ablation remains uncertain. In this single-center retrospective cohort study, we evaluated pre-procedural and post-procedural HFA-PEFF scores in 856 patients with preserved left ventricular ejection fraction (≥ 50%) undergoing index AF ablation. HF hospitalization from 1 year after ablation was compared across risk strata (low, 0-1; intermediate, 2-4; high, 5-6 points) for both scores. Discrimination was assessed using time-dependent receiver operating characteristic analysis at 2-5 years. Post-procedural HFA-PEFF was assessed at a median of 91 (interquartile range, 87-97) days after ablation, and 92.8% of reassessments were obtained during sinus rhythm or atrial pacing. The HFA-PEFF score decreased significantly from 3 (2-4) to 2 (1-4) (p < 0.001), driven primarily by changes in the biomarker domain. During a median follow-up of 5.2 (3.5-7.6) years, 34 patients (4.0%) had HF hospitalization. Post-procedural HFA-PEFF showed higher discrimination than the pre-procedural score, especially at 5 years (area under the curve [95% confidence interval], 0.791 [0.686-0.896] versus 0.686 [0.562-0.809]; p = 0.028). In subgroup analyses, discrimination for change-based HFA-PEFF improvement (Δ ≤ -1 versus Δ ≥ 0) was greater in the baseline high-risk stratum (0.784 [0.635-0.934]) than in the low/intermediate-risk stratum (0.647 [0.546-0.748]). In patients with preserved left ventricular ejection fraction undergoing AF ablation, post-procedural HFA-PEFF reassessment may add value for long-term HF hospitalization risk stratification, particularly in those with high baseline HFA-PEFF scores.

PMID 42440803
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PubMedPostgraduate medicine2026-07-12

Ponatinib in CML and Ph+ ALL: balancing high efficacy with vascular safety.

Senthil Arihant A, Gupta Aarushi A, Bansal Vasu V, Antony Caroline C et al.

Chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) are driven by the BCR:ABL1 fusion and remain highly responsive to tyrosine kinase inhibitors (TKIs). Ponatinib, a third-generation TKI, uniquely retains activity against the T315I 'gatekeeper' mutation and most other BCR:ABL1 variants, producing deep cytogenetic and molecular responses in resistant CML and improving survival in Ph+ ALL. Across the PACE and OPTIC programs, frontline Ph+ ALL combinations (hyper-CVAD- and blinatumomab-based), and real-world cohorts, ponatinib demonstrates robust antileukemic efficacy in diverse settings and after multiple prior TKIs. However, its multikinase profile confers a clinically meaningful risk of arterial occlusive events (AOEs)-including coronary, cerebrovascular, and peripheral arterial complications-whose incidence is shaped by baseline cardiovascular risk and overall drug exposure. Mechanistic studies suggest that endothelial dysfunction, pro-inflammatory signaling, impaired nitric oxide bioavailability, and microvascular rarefaction contribute to ponatinib-associated vascular toxicity. Clinically, response-based dosing-such as step-down from 45→30→15 mg in CML or 30→15 mg in Ph+ ALL upon molecular milestones-preserves efficacy while reducing exposure-related AOE risk, though events are not eliminated. Emerging cardio-oncology strategies can further mitigate harm: baseline risk stratification (e.g. SCORE2/SCORE2-OP, HFA-ICOS), aggressive management of blood pressure and lipids, selective antiplatelet prophylaxis in high-risk profiles, and close longitudinal surveillance. Overall, contemporary evidence supports ponatinib as a high-potency option for T315I disease and multi-tyrosine kinase inhibitor (TKI) resistance, and as a practical component of modern Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) therapy, provided that dosing is individualized and cardiovascular risk is proactively managed. Future priorities include refining patient selection, validating preventive cardio-oncology bundles, and defining minimal-effective exposure thresholds that sustain durable disease control with the lowest feasible vascular liability.

PMID 42436599
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