Tharimmune
Clinical Trials
2
Trial Phases
2 Phases
Drug Approvals
0
Drug Approvals
No drug approvals found
This company may not have drug approvals in our database
Clinical Trials
Distribution across different clinical trial phases (2 trials with phase data)• Click on a phase to view related trials
TH104 for the Treatment of Pruritus in Primary Biliary Cholangitis
- Conditions
- PruritusPrimary Biliary Cholangitis
- Interventions
- Drug: Placebo
- First Posted Date
- 2024-12-13
- Last Posted Date
- 2024-12-17
- Lead Sponsor
- Tharimmune Inc
- Target Recruit Count
- 40
- Registration Number
- NCT06733519
An Evaluation of The Absolute Bioavailability of TH104
- First Posted Date
- 2024-01-10
- Last Posted Date
- 2025-04-08
- Lead Sponsor
- Tharimmune Inc
- Target Recruit Count
- 20
- Registration Number
- NCT06198686
- Locations
- 🇺🇸
Novum Pharmaceutical Research Services, Las Vegas, Nevada, United States
News
Tharimmune Appoints New CEO and Board Members to Advance Opioid Antagonist TH104 Development
Tharimmune announced key leadership changes with Sireesh Appajosyula becoming CEO and Vincent LoPriore appointed Executive Chairman in June 2025.
FDA Clears Expedited Pathway for Tharimmune's TH104 Opioid Defense Drug Without Additional Clinical Trials
Tharimmune received positive FDA feedback allowing a 505(b)(2) NDA submission for TH104 as prophylaxis against ultrapotent opioid exposure, with no additional clinical trials required.
Tharimmune Reports Breakthrough in Oral Delivery of TNF-α Inhibitor for Inflammatory Diseases
Tharimmune's novel oral antibody TH023 demonstrated successful delivery of infliximab in preclinical studies, achieving serum concentrations higher than required for therapeutic efficacy in standard injection treatments.
Tharimmune's TH104 Advances to Phase 2 for Pruritus in Primary Biliary Cholangitis
Tharimmune plans to initiate a Phase 2 clinical trial in 2025 to evaluate TH104 for moderate-to-severe pruritus associated with primary biliary cholangitis (PBC).
Pharma Update: FDA Eases CGT Path, Tharimmune Surges on EMA Feedback, Lexeo Dips on Alzheimer's Data
The FDA is creating a more accessible regulatory environment for cell and gene therapy companies, according to executives at BioFuture 2024.
Tharimmune's TH104 Receives Positive EMA Feedback for Pruritus in Primary Biliary Cholangitis
Tharimmune received positive feedback from the EMA regarding its Phase 2 and Phase 3 clinical program for TH104, targeting moderate-to-severe pruritus in primary biliary cholangitis (PBC).
EMA Endorses Tharimmune's TH104 Clinical Program for Chronic Pruritus in Primary Biliary Cholangitis
The EMA has endorsed Tharimmune's TH104 clinical program for chronic pruritus in primary biliary cholangitis (PBC), supporting the company's development strategy.