SPONTAN to be Evaluated in Pulmonary Arterial Hypertension
Released
Released
Announcement PDF
1800 519 711 | ltrpharma.com | investors@ltrpharma.com
LTR Pharma Limited (ABN 64 644 924 569 / ACN 644 924 569)
SPONTAN®
to be Evaluated in Pulmonary Arterial Hypertension
Following Ethics Approval
22 October 2026
Highlights
• Ethics approval received for an investigator-initiated clinical study evaluating SPONTAN®
in pulmonary ar-
terial hypertension (PAH), a serious, progressive and currently incurable disease.
• PAH represents a significant global therapeutics market, estimated at US$8.0 billion in 2024 and forecast
by third-party sources to reach up to US$17.9 billion by 2034.1,2
• PDE5 inhibition is an established treatment approach in PAH; the study will evaluate whether SPONTAN
can produce a measurable haemodynamic effect within 15 minutes.
• Study independently led by Professor David Celermajer, Head of the Department of Cardiology at Royal
Prince Alfred Hospital.
• The study represents a further clinical evaluation of LTR’s intranasal platform beyond erectile dysfunction,
exploring its potential application in another significant therapeutic area.
LTR Pharma Limited (ASX: LTP) (“LTR Pharma” or “the Company”) is pleased to announce that the Bellberry Human
Research Ethics Committee (HREC) has approved an investigator-initiated clinical study evaluating SPONTAN®
in
patients with newly diagnosed and untreated Pulmonary Arterial Hypertension (PAH). The study will be inde-
pendently designed, led and conducted by Professor David Celermajer, Head of the Department of Cardiology at
Royal Prince Alfred Hospital, Scandrett Professor of Cardiology at the University of Sydney and Clinical Director of
the Heart Research Institute.
PAH is a serious, progressive and currently incurable disease in which narrowing of the pulmonary arteries in-
creases resistance to blood flow and places increasing strain on the right side of the heart, potentially leading to
right-heart failure. Despite advances in treatment, there remains a need for differentiated therapeutic ap-
proaches.
PDE5 inhibitors, including sildenafil and tadalafil, are established PAH therapies. However, oral administration
requires gastrointestinal absorption before reaching systemic circulation, with peak blood concentrations typically
occurring approximately 30 minutes to two hours after dosing.
SPONTAN is LTR Pharma’s intranasal formulation of vardenafil, another PDE5 inhibitor. Previous pharmacokinetic
studies have demonstrated rapid absorption following SPONTAN’s administration. The PAH study will explore
whether SPONTAN’s rapid systemic exposure can translate into a measurable haemodynamic effect within 15
minutes, providing early clinical data on its potential as a differentiated treatment approach in PAH.
1800 519 711 | ltrpharma.com | investors@ltrpharma.com
LTR Pharma Limited (ABN 64 644 924 569 / ACN 644 924 569)
About the Study
The investigator-initiated clinical study will evaluate whether a single intranasal dose of SPONTAN can rapidly
reduce pulmonary vascular resistance (PVR) in newly diagnosed, untreated PAH patients. Haemodynamic effects
will be assessed 15 minutes following administration, together with safety and tolerability.
The study is expected to commence in the coming quarter ending 31 December 2026. LTR Pharma will provide
further updates as material milestones are achieved.
Professor David Celermajer said:
“Oral PDE5 inhibitors are an established part of PAH treatment. This study will directly measure whether intranasal
SPONTAN can rapidly reduce pulmonary vascular resistance in newly diagnosed, untreated patients. The con-
trolled haemodynamic assessment will provide important early clinical data on the potential of SPONTAN in PAH.”
Strategic Significance
The PAH study represents a further evaluation of LTR Pharma’s rapid-acting intranasal platform beyond erectile
dysfunction and follows the OROFLOW®
study in oesophageal motility disorders announced in June 2026. To-
gether, these studies demonstrate the expanding clinical potential of LTR’s intranasal platform across multiple
therapeutic areas where rapid systemic exposure may offer meaningful clinical differentiation.
The study is expected to generate early clinical data on SPONTAN’s potential in PAH. Positive results could provide
a foundation for LTR Pharma to evaluate further clinical development and commercial opportunities in this signif-
icant therapeutic market.
Despite advances in treatment, PAH remains incurable and can progress to right-heart failure, sustaining demand
for differentiated therapies. Grand View Research estimates the global PAH therapeutics market at US$8.0 billion
in 2024, growing at 5.9% annually to reach US$13.3 billion by 2033,1 while GlobalData forecasts sales across 68
markets rising from US$10.1 billion in 2024 to US$17.9 billion by 2034.2 Market forecasts are third-party estimates
and are not forecasts of LTR Pharma revenue.
The study is funded through an LTR Pharma research grant administered by the Sydney Local Health District. As
an investigator-initiated study, it is designed, led and conducted independently by Professor Celermajer and his
team.
LTR Pharma Executive Chairman, Lee Rodne, said:
“This study represents another important opportunity to evaluate LTR Pharma’s intranasal platform in a serious
disease with significant unmet need and a large global market.
PDE5 inhibition is already an established treatment approach in PAH. The opportunity we are exploring is whether
SPONTAN can produce a rapid, measurable haemodynamic effect within minutes of administration.
Importantly, this investigator-initiated study is being independently led by Professor Celermajer and provides an
efficient pathway to generate early clinical data in another potentially valuable therapeutic application. Together
with OROFLOW, it further demonstrates the broader potential of our intranasal platform beyond erectile dysfunc-
tion.”
1800 519 711 | ltrpharma.com | investors@ltrpharma.com
LTR Pharma Limited (ABN 64 644 924 569 / ACN 644 924 569)
About Pulmonary Arterial Hypertension
PAH is a rare, progressive and currently incurable disease characterised by narrowing of the pulmonary arteries,
increasing resistance to blood flow and placing growing strain on the right side of the heart. Symptoms can include
shortness of breath, fatigue, reduced exercise capacity, chest pain, palpitations, dizziness and fainting, with ad-
vanced disease potentially leading to right-heart failure.
- ENDS -
This announcement has been approved by the Board of Directors.
1
Grand View Research, Pulmonary Arterial Hypertension Market Size, Share & Trends Analysis Report, 2025–2033 (base year 2024; published 2025).
2
GlobalData, Pulmonary Arterial Hypertension – Global Drug Forecast and Market Analysis, 2024.
About LTR Pharma
LTR Pharma is a commercial-stage pharmaceutical company delivering innovative therapies to address significant
unmet medical needs through its proprietary rapid-acting intranasal platform. The Company has successfully
commercialised its rapid-acting treatment technology in Australia and is expanding access whilst advancing regu-
latory pathways in the US and other key markets.
LTR’s lead products, SPONTAN®
and ROXUS®
, are fast-acting intranasal sprays for the treatment of erectile dys-
function, enabling onset of action in 10 minutes or less. Building on this proven technology, the Company is now
advancing OROFLOW®
, a novel intranasal spray under development for the treatment of Oesophageal Motility
Disorders (OMD) – a debilitating group of conditions affecting swallowing function.
Through strategic partnerships, LTR Pharma is expanding its pipeline and global footprint to deliver differentiated,
patient-centric treatments that enhance quality of life.
1800 519 711 | ltrpharma.com | investors@ltrpharma.com
LTR Pharma Limited (ABN 64 644 924 569 / ACN 644 924 569)
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