Companies: Hillhurst Biopharmaceuticals Inc.
Drugs: HBI-002, carbon monoxide
Hillhurst Bio doses first subject in Phase 2a HBI-002 Parkinson's trial
100% citation coverage1 regulatory sources
Intelligence Snapshot
Executive Summary
Hillhurst Bio has initiated a Phase 2a clinical trial for HBI-002 in patients with Parkinson's disease , with the first subject now dosed.
Key Insights
- HBI-002 is an oral low-dose carbon monoxide therapeutic candidate .
-
The Phase 2a trial is currently recruiting and will assess safety, tolerability,…
The Phase 2a trial is currently recruiting and will assess safety, tolerability, pharmacokinetics, and biomarkers across multiple centers.
- Hillhurst is also developing HBI-002 in a Phase 1/2 study for sickle cell disease .
Market Impact
| Regulatory | medium |
|---|---|
| Commercial | medium |
| Competitive | high |
| Investment | medium |
Hillhurst Bio doses first subject in a Phase 2a clinical trial of HBI-002 for Parkinson's disease. The study is recruiting and is listed on ClinicalTrials.gov as a randomized, double-blind, placebo-controlled multiple-dose trial evaluating safety, tolerability, and biomarkers in patients with the neurodegenerative condition.
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Key Questions
- What is HBI-002?
- What indications is HBI-002 being studied for?
- What is the trial design for the Parkinson's study?
- What is the scientific basis for studying carbon monoxide in Parkinson's disease?
- Has HBI-002 been tested before?
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Contents9 sections
Hillhurst Bio Doses First Subject in Phase 2a HBI-002 Parkinson's Trial
Key Takeaways
- Hillhurst Bio has initiated a Phase 2a clinical trial for HBI-002 in patients with Parkinson's disease, with the first subject now dosed.
- HBI-002 is an oral low-dose carbon monoxide therapeutic candidate.
- The Phase 2a trial is currently recruiting and will assess safety, tolerability, pharmacokinetics, and biomarkers across multiple centers.
- Hillhurst is also developing HBI-002 in a Phase 1/2 study for sickle cell disease.
IntelligenceRegulatory Impact
FDA decisions frame this story. Regulatory relevance is medium for Parkinson's disease, with HBI-002 and carbon monoxide most exposed. Track designations, submission types, and label or guidance shifts that could move timelines.
The Development
Hillhurst Biopharmaceuticals Inc. has advanced HBI-002 into a Phase 2a multicenter, randomized, double-blind, placebo-controlled multiple-dose study in Parkinson's disease. The trial, registered as NCT07005180 on ClinicalTrials.gov, has now dosed its first subject and remains in recruiting status.
The study is designed to evaluate safety, tolerability, pharmacokinetics, and biomarkers in Parkinson's disease patients. Research suggests that low doses of carbon monoxide may protect against neuronal cell loss in Parkinson's disease, providing the scientific rationale for the trial.
The company previously completed a Phase 1 trial assessing the safety and pharmacokinetics of HBI-002 in healthy volunteers. That earlier study established foundational safety data for the program.
IntelligenceCompetitive Intelligence
Competitive pressure is high. Hillhurst Biopharmaceuticals Inc. reshape positioning, formulary leverage, and partnership options. Benchmark pipeline differentiation and regional market access assumptions against this development.
Parallel Development in Sickle Cell Disease
Beyond the Parkinson's program, Hillhurst is evaluating HBI-002 in a Phase 1/2 trial for sickle cell disease, which is also currently recruiting. The company has also filed HBI-002 for evaluation of its potential to prevent vaso-occlusive crises in patients with sickle cell disease.
These two active programs represent the extent of HBI-002 development disclosed in the current trial registry. No other indications or development stages are confirmed in available sources.
IntelligenceMarket Signals
Commercial pull is medium and investment relevance medium for Parkinson's disease. Expect implications for pricing, access, and launch sequencing.
What the Evidence Confirms
The trial registry and supporting sources confirm four core facts about HBI-002 and its development status. First, HBI-002 is an oral low-dose carbon monoxide therapeutic candidate. Second, the Parkinson's trial (NCT07005180) is in Phase 2a and recruiting. Third, a separate Phase 1/2 study in sickle cell disease is also recruiting. Fourth, the scientific premise linking low-dose carbon monoxide to neuroprotection in Parkinson's disease is documented in the trial rationale.
The sources do not confirm approval status, sales projections, enrollment targets, specific biomarker endpoints, or comparative efficacy data. No timeline for Phase 2a completion or advancement decisions has been disclosed.
IntelligenceStrategic Takeaways
Hillhurst Bio has initiated a Phase 2a clinical trial for HBI-002 in patients with Parkinson's disease , with the first subject now dosed. HBI-002 is an oral low-dose carbon monoxide therapeutic candidate . The Phase 2a trial is currently recruiting and will assess safety, tolerability, pharmacokinetics, and biomarkers across multiple centers.
Trial Snapshot
| Trial | Title | Status | Phase | Sponsor |
|---|---|---|---|---|
| NCT07005180 | Low-dose Carbon Monoxide (HBI-002) Trial to Evaluate Safety, Tolerability, PK, and Biomarkers in Parkinson's Disease | RECRUITING | PHASE2 | Hillhurst Biopharmaceuticals, Inc. |
| NCT06144749 | A Safety, Efficacy, and Pharmacokinetic (PK) Study of HBI-002, an Oral Carbon Monoxide (CO) Therapeutic, in Subjects With Sickle Cell Disease (SCD) | RECRUITING | PHASE1, PHASE2 | Hillhurst Biopharmaceuticals, Inc. |
| NCT03926819 | A Study to Assess the Safety and Pharmacokinetics of HBI-002, an Oral Carbon Monoxide Therapeutic, in Healthy Volunteers | COMPLETED | PHASE1 | Hillhurst Biopharmaceuticals, Inc. |
| NCT05415761 | Comparative Effectiveness of Mobile Health Smoking Cessation Approaches Among Underserved Patients in Primary Care | RECRUITING | NA | University of Florida |
| NCT05480904 | Characterizing Sleep Among Long-term Survivors of Childhood Cancer | ACTIVE_NOT_RECRUITING | — | St. Jude Children's Research Hospital |
IntelligenceEvidence Quality
Grounded in 1 regulatory source.
Competitor Matrix
| Company / Program | Indication | Active trials |
|---|---|---|
| Fasikl Inc. | Parkinson's disease | 1 |
| Annovis Bio Inc. | Parkinson's disease | 1 |
| Rennes University Hospital | Parkinson's disease | 1 |
| Medical University of South Carolina | Parkinson's disease | 1 |
| Energenesis Biomedical Co., Ltd. | Parkinson's disease | 1 |
| McMaster University | Parkinson's disease | 1 |
Timeline
- Recruiting trial NCT07005180 (PHASE2)
- Recruiting trial NCT06144749 (PHASE1, PHASE2)
- Recruiting trial NCT05415761 (NA)
- Active_Not_Recruiting trial NCT05480904 (phase n/a)
- Recruiting trial NCT06601998 (phase n/a)
Frequently Asked Questions
What is HBI-002?
HBI-002 is an oral low-dose carbon monoxide therapeutic candidate being developed by Hillhurst Biopharmaceuticals Inc.
What indications is HBI-002 being studied for?
HBI-002 is currently in clinical development for two indications. A Phase 2a trial is evaluating HBI-002 in Parkinson's disease, and a Phase 1/2 trial is assessing its use in sickle cell disease.
What is the trial design for the Parkinson's study?
The Phase 2a trial is a multicenter, randomized, double-blind, placebo-controlled multiple-dose study designed to evaluate safety, tolerability, pharmacokinetics, and biomarkers. The trial is registered as NCT07005180 and is actively recruiting participants.
What is the scientific basis for studying carbon monoxide in Parkinson's disease?
Research suggests that low doses of carbon monoxide may protect against neuronal cell loss in Parkinson's disease. This premise forms the rationale documented in the trial registry.
Has HBI-002 been tested before?
Yes. A Phase 1 trial assessing the safety and pharmacokinetics of HBI-002 in healthy volunteers has been completed.
What happens next with the Parkinson's trial?
The Phase 2a trial is actively recruiting. No completion date, enrollment target, or interim analysis timeline has been disclosed in the trial registry or supporting sources.
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- Sources analyzed
- 1
- Evidence strength
- 93/100
- Last verified
- Jun 15, 2026
- AI-assisted review
- Yes
- Editorial review
- Dr. Sarah Chen
Critical source quality · grounded in cited primary and secondary sources.
Sources & references 1 primary sources
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