tivoxavir marboxil (TRX100) / Traws Pharma - LARVOL DELTA

Study of TRX-100 Evaluating the Safety, Pharmacokinetics, and Food Effect in Healthy Volunteers (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Traws Pharma, Inc. | N=24 ➔ 32

Enrollment change

Study of TRX-100 Tablets Evaluating the Safety, Pharmacokinetics, and Food Effect in Healthy Volunteers (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Traws Pharma, Inc. | Not yet recruiting ➔ Recruiting | N=16 ➔ 24

Enrollment change • Enrollment open • Trial initiation date

Study of TRX-100 Tablets Evaluating the Safety, Pharmacokinetics, and Food Effect in Healthy Volunteers (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Traws Pharma, Inc.

New P1 trial

Phase 2a Study of the Efficacy and Safety of TRX-100 in a Human Influenza A Challenge Model (clinicaltrials.gov) - P2 | N=165 | Not yet recruiting | Sponsor: Traws Pharma, Inc.

New P2 trial • Infectious Disease • Influenza • Respiratory Diseases

Effect of Doum (Hyphaene thebaica) mesocarp and endosperm extracts on Triton X-100 induced hyperlipidemic rat: mitigative cardiovascular and renal dysfunction risks. (PubMed, Front Nutr) - "Wistar rats were divided into seven groups: a negative control, a Triton X-100 (TrX-100)-induced hyperlipidemic model group, a group treated with atorvastatin, and groups receiving DM or DE at doses of 500 or 1,000 mg/kg alongside TrX-100 induction. The performance of DM was dose-dependent. A Low dose of DE had a more pronounced effect than a high dose, making it a point for future research on DE safety and reliability."

Journal • Preclinical • Cardiovascular • Dyslipidemia • Hypertriglyceridemia • Nephrology • Renal Disease

A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of TRX-100 Tablets Evaluating the Safety, Pharmacokinetics, and Food Effect of Single Ascending Doses of TRX-100 in Healthy Volunteers (ANZCTR) - P1 | N=16 | Not yet recruiting | Sponsor: Traws Pharma, Inc

New P1 trial • Infectious Disease • Influenza • Respiratory Diseases

This is an Early-stage Clinical Trial to Determine a Safe and Effective Dose for Tivoxavir Marboxil in Patients With Mild to Moderate Influenza (clinicaltrials.gov) - P2 | N=105 | Active, not recruiting | Sponsor: Traws Pharma, Inc. | Trial completion date: Jun 2026 ➔ Jan 2027 | Trial primary completion date: Jun 2026 ➔ Dec 2026 | Withdrawn ➔ Active, not recruiting

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Influenza • Respiratory Diseases

This is an Early-stage Clinical Trial to Determine a Safe and Effective Dose for Tivoxavir Marboxil in Patients With Mild to Moderate Influenza (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Traws Pharma, Inc.

New P2 trial • Infectious Disease • Influenza • Respiratory Diseases

A Clinical Study Aiming to Assess Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TRX-100 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=66 | Completed | Sponsor: Traws Pharma, Inc. | Recruiting ➔ Completed | N=32 ➔ 66

Enrollment change • Trial completion

Traws Pharma Files Tivoxavir Marboxil Investigational New Drug (IND) Application for Influenza Therapy... (The Manila Times)

IND • Influenza

A Randomized, Double-Blind, Placebo-Controlled, Phase 1, Dose Escalation (with optional food effect) Study of Orally Administered TRX-100 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of TRX-100 in Healthy Volunteers (ANZCTR) - P1 | N=40 | Completed | Sponsor: Trawsfynydd Therapeutics AU Pty Ltd (on behalf of Traws Pharma, Inc.) | Recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

A Clinical Study Aiming to Assess Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TRX-100 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Traws Pharma, Inc.

New P1 trial

A Randomized, Double-Blind, Placebo-Controlled, Phase 1, Dose Escalation (with optional food effect) Study of Orally Administered TRX-100 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of TRX-100 in Healthy Volunteers (ANZCTR) - P1 | N=40 | Recruiting | Sponsor: Trawsfynydd Therapeutics AU Pty Ltd (on behalf of Traws Pharma, Inc.) | Not yet recruiting ➔ Recruiting | Initiation date: Aug 2024

Enrollment open • Trial initiation date • Infectious Disease • Influenza • Respiratory Diseases