Citius Pharmaceuticals has enrolled the first subject in the Phase IIb clinical trial of its therapy Halo-Lido to treat haemorrhoids. 

The company anticipates results from the trial in the second half of next year.

A topical formulation of halobetasol and lidocaine, Halo-Lido is designed to offer symptomatic relief to people with haemorrhoids. 

On securing the US Food and Drug Administration (FDA) approval, Halo-Lido could become the first prescription product indicated to treat haemorrhoids.

The double-blind, randomised, multicentre, dose-ranging, parallel-group comparison trial will have five cohorts of adult subjects with symptomatic Goligher’s classification Grade II or Grade III haemorrhoids. 

It will enol a total of 300 subjects with nearly 60 subjects in each cohort.

GlobalData Strategic Intelligence

US Tariffs are shifting - will you react or anticipate?

Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

By GlobalData

Assessing the ability of the formulations of Halo-Lido used in each cohort to offer relief to trial subjects with acute flare-ups is the main goal of the trial. 

Furthermore, the trial will assess the decline in haemorrhoidal symptoms including pain, burning, itching, and swelling on receiving Halo-Lido as the primary endpoint.

It is intended to offer the foundation for the development of the Phase III trial. 

Citius Pharmaceuticals executive chairman Leonard Mazur said: “We are pleased to have initiated the Halo-Lido study and expect to complete enrolment later this year. 

“Currently, there are no FDA-approved prescription-strength treatments available to the millions of adults who suffer from haemorrhoid discomfort each year. 

“Assuming study results are positive, and in order to realise the full potential of Halo-Lido, we intend to seek strategic or financial partners for this asset at the appropriate time.”

Haemorrhoid is a gastrointestinal disorder that causes pain, swelling, itching, tenderness and bleeding.

The company enrolled the first patient in a Phase III trial of Mino-Loktherapy plus systemic antibiotics to treat catheter-related bacteremias (CRBSIs) in February 2018.

Clinical Trials Arena Excellence Awards - The Benefits of Entering

Gain the recognition you deserve! The Clinical Trials Arena Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving clinical trials industry advancements. Don’t miss your chance to stand out—submit your entry today!

Nominate Now