LTR Pharma (ASX:LTP) Gets Ethics Green Light to Take Intranasal OROFLOW Into Human Clinical Testing

Aditi Sarkar

13 August 2026 12:10 PM AEST

LTR Pharma (ASX:LTP) Gets Ethics Green Light to Take Intranasal OROFLOW Into Human Clinical Testing

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Highlights

LTR Pharma received Human Research Ethics Committee approval for a pilot clinical study of OROFLOW.
OROFLOW is an intranasal spray formulation being developed for oesophageal motility disorders.
The study will include healthy volunteers and patients with conditions including achalasia and oesophageal spasm.
LTR Pharma reported cash of A$19.6 million at 30 June 2026 and entered U.S. commercial agreements for ROXUS.

LTR Pharma (ASX:LTP) has received ethics approval to begin human testing of OROFLOW, its second intranasal drug candidate targeting oesophageal motility disorders.

The South Eastern Sydney Local Health District Human Research Ethics Committee approved an investigator-initiated pilot clinical study evaluating the nasal spray formulation in patients with swallowing-related conditions.

The approval represents an early clinical development milestone for LTR Pharma, expanding the company's intranasal delivery platform beyond its primary men's health program. However, the study remains an early-stage investigation and does not represent confirmation of clinical effectiveness or regulatory approval.

What Was Announced?

On 24 June 2026, LTR Pharma announced that it had received Human Research Ethics Committee (HREC) approval for a pilot clinical study of OROFLOW, an intranasal spray containing a PDE5 inhibitor, in patients with oesophageal motility disorders.

The approved study will be conducted at St George Hospital in Sydney and led by Dr Peter Wu, Director of St George Motility Services.

The two-stage investigator-initiated pilot study will first assess the drug's time-course of effect in healthy volunteers. The second stage will evaluate patients with conditions including achalasia, oesophageal outflow obstruction, diffuse oesophageal spasm and hypercontractile oesophagus.

Many participants in the patient stage are expected to already be scheduled for Peroral Endoscopic Myotomy (POEM), a surgical procedure used to treat certain swallowing disorders.

LTR Pharma expects the study to begin in the second half of 2026.

Why This Matters

For LTR Pharma (ASX:LTP), OROFLOW provides an opportunity to apply its intranasal delivery technology in a new therapeutic area beyond its existing men's health focus.

Current treatment Options for oesophageal motility disorders include procedures such as surgery, balloon dilation and botulinum toxin injections. A fast-acting nasal spray, if shown to be effective, could provide an alternative administration approach.

However, OROFLOW remains at an early development stage. The current study is a pilot investigation rather than a registration-enabling clinical trial, and no efficacy data has yet been generated in this indication.

The program represents pipeline diversification, while the company's nearer-term commercial focus remains linked to its SPONTAN/ROXUS product.

Company Background

LTR Pharma (ASX:LTP) is an ASX-listed clinical-stage pharmaceutical company focused on intranasal drug delivery technology.

Its lead product, SPONTAN, marketed in the United States as ROXUS, is a fast-acting nasal spray formulation of a PDE5 inhibitor being developed for erectile dysfunction.

The company has reported pharmacokinetic data showing a median time-to-maximum drug concentration of approximately 10 minutes for SPONTAN compared with around 60 minutes for oral vardenafil in a 27-subject study.

OROFLOW was developed through a collaboration with Strategic Drug Solutions and represents the company's first disclosed application of its nasal delivery platform outside men's health.

Financial Position

LTR Pharma reported cash of A$19.6 million at 30 June 2026 and a debt-free balance sheet.

The company stated that available funds are sufficient to support planned activities through the remainder of 2026 and into 2027.

In July 2026, LTR Pharma entered two U.S. commercial agreements supporting the planned ROXUS launch.

The company signed a distribution agreement with Shed Holdings LLC, trading as Mavrox, involving a minimum commitment of 150,000 ROXUS prescription units over the first 12 months, subject to performance conditions.

LTR Pharma also entered a fulfilment agreement with Strive Specialties Inc., providing prescription fulfilment services for ROXUS through a licensed Section 503A compounding pharmacy network.

What Comes Next?

The next milestones for LTR Pharma (ASX:LTP) include commencement of OROFLOW stage one dosing in healthy volunteers, followed by stage two enrolment of patients with oesophageal motility disorders.

The company expects these activities to occur during the second half of 2026.

For SPONTAN/ROXUS, the near-term focus remains the planned U.S. commercial launch targeted for the second half of 2026, alongside final pharmacokinetic data analysis expected in the third quarter of 2026.

Further OROFLOW development will depend on pilot study results and decisions around larger clinical programs.

Risks

LTR Pharma (ASX:LTP) faces clinical development risk as OROFLOW remains in an early-stage pilot study without demonstrated efficacy data. The program may not generate sufficient results to support further development. The planned ROXUS launch also depends on commercial partner execution, prescription volumes and the regulatory framework applicable to compounded products. As the company expands its pipeline and enters new markets, funding requirements and operational execution remain important considerations.

Investor Takeaway

LTR Pharma has reached an initial clinical milestone for OROFLOW through ethics approval of a human pilot study targeting oesophageal motility disorders.

The development expands the company's intranasal platform into a new therapeutic area, but the study remains exploratory and does not establish clinical effectiveness.

For LTR Pharma (ASX:LTP), the more immediate commercial focus remains the planned ROXUS U.S. launch and execution of recently established distribution and fulfilment arrangements. OROFLOW represents longer-term pipeline potential that will depend on future clinical outcomes and development decisions.

FAQs

Q: What is OROFLOW?

A:OROFLOW is an intranasal spray formulation being developed by LTR Pharma for oesophageal motility disorders.

Q: What did LTR Pharma receive ethics approval for?

A:LTR Pharma received approval for an investigator-initiated pilot clinical study evaluating OROFLOW in healthy volunteers and patients.

Q: When will the OROFLOW study begin?

A:LTR Pharma expects the study to begin in the second half of 2026.

Q: What is LTR Pharma's main commercial product?

A:LTR Pharma's lead commercial program is SPONTAN, marketed in the United States as ROXUS, a nasal spray formulation for erectile dysfunction.

Q: What was LTR Pharma's cash position at 30 June 2026?

A:LTR Pharma reported cash of A$19.6 million at 30 June 2026.

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