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NASDAQ: HELP |  CBOE CA: HELP

Clinical Trials

A Paradigm Shift in Mental Health Care

At Helus Pharma, we strategically innovate novel serotonergic agonists (NSAs) that set new standards in mental health, for conditions such as depression and anxiety. Our cutting-edge research, clinical excellence, and commitment to patient-centered innovation empowers individuals to durable recovery.  We are conducting clinical trials to evaluate these novel therapies designed to address the unmet needs of individuals seeking better treatment options.  In our clinical trials, participants have the opportunity to contribute to paradigm shifting research that could change the future of mental health care. We are currently investigating HLP0031, a proprietary deuterated NSA, in Phase 3 trials, which has shown promise in earlier studies to quickly and sustainably improve symptoms of depression. Additionally, we are advancing the development of HLP0042, a proprietary deuterated NSA molecule being studied for its potential to improve symptoms of anxiety disorders.  These investigational medicines are not currently approved to be sold in any country. The purpose of these trials is to show that they are safe and effective. Participation not only helps us advance science but also brings us one step closer to providing new hope for those struggling with mental health challenges. Each trial is conducted in close collaboration with healthcare professionals and under rigorous safety standards to ensure participants’ well-being throughout the process. 

Notes:
1 – Formerly referred to as CYB003
2- Formerly referred to as CYB004

Ongoing Clinical Trials

Helus Pharma is currently sponsoring the following trials. You can click on the trial title for more information (if available) and on the recruitment link to find details on how to participate should you be interested. 

Trial Name
Product
Status
Condition
Phase
Location
Recruitment Link
A study of CYB003 in Humans with Major Depressive Disorder

(APPROACH)
HLP003
Recruiting
Major Depressive Disorder
3
USA

Learn More
Apply for Trial Here
A Phase 3 Trial to Assess CYB003 in Major Depressive Disorder

(EMBRACE)
HLP003
Recruiting
Major Depressive Disorder
3
Australia, Czech Republic, Germany, Greece, Ireland, Poland, UK, USA

Learn More
Apply for Trial Here
Phase III Long-term Extension Trial to Assess Safety and Efficacy of CYB003 in MDD

(EXTEND)
HLP003
Participants invited following completion of APPROACH & EMBRACE
Major Depressive Disorder
3
Same as APPROACH & EMBRACE
Participants will need to complete either the APPROACH or EMBRACE trial to participate

APPROACH

A study of CYB003 in Humans with Major Depressive Disorder
(Phase 3)

Status:

Recruiting

Condition:

Major Depressive Disorder

Location:

USA

(Learn More)

Recruitment Link:

Apply for the Trial Here

EMBRACE

A Phase 3 Trial to Assess CYB003 in Major Depressive Disorder (Phase 3)

Status:

Recruiting

Condition:

Major Depressive Disorder

Location:

Australia, Czech Republic, Germany, Greece, Ireland, Poland, UK, USA

(Learn More)

Recruitment Link:

Apply for the Trial Here

EXTEND

Phase 3 Long-term Extension Trial to Assess Safety and Efficacy of CY003 in MDD
(Phase 3)

Status:

Participants invited following completion of APPROACH & EMBRACE

Condition:

Major Depressive Disorder

Location:

Same as APPROACH & EMBRACE

Recruitment Link:

Participants will need to complete either the APPROACH or EMBRACE trial to participate.