The Phase llb trial includes around 300 adults with symptomatic haemorrhoids. Credit: Nephron / commons.wikimedia.org.

Citius Pharmaceuticals has concluded enrolment of patients in its Phase llb trial of Halo-Lido (CITI-002) for the treatment of haemorrhoids, a gastrointestinal disorder.

CITI-002, which is a topical formulation to treat haemorrhoids, is yet to receive approval from the US Food and Drug Administration (FDA).

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The Phase llb trial includes around 300 adults, who have been diagnosed with symptomatic haemorrhoids.

The multi-centre, randomised, dose-ranging, double-blind, parallel group comparison study expects to publish topline data by the end of the second quarter of this year.

Its primary objective is the change in haemorrhoidal symptoms that the patients report post-treatment.

The patients are keeping track of efficacy and safety data using a proprietary mobile-based Patient Reported Outcome (ePRO) tool.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Following the publication of topline results, Citius Pharmaceuticals plans to initiate a Phase lll trial.

Citius Pharmaceuticals executive chairman Leonard Mazur said: “The study was fully enrolled within one year from initiation.

“We continue to believe that the global market for a prescription topical treatment for haemorrhoids is large and underserved.

“Contingent on the trial data, we expect to continue to advance this programme to maximise its value.”

In September last year, Citius Pharmaceuticals announced a clinical collaboration with the University of Pittsburgh for a Phase I/Ib study of I/ONTAK (denileukin diftitox or E7777) in combination with pembrolizumab to treat recurrent or metastatic solid tumours.