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TNP-2092

Phase 1

Hyperammonemia | Small molecule | Other |cbdMD, Inc.|Last Updated: Apr 25, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker

Total Trials1

Total Enrollment58

FDA Designations

No designations recorded

Clinical trial landscape

TNP-2092 · 1 trial · 1 indication

Phase 1 1

NCT06178718A Phase 1 Study to Evaluate PK Profile and Food Effects on PK Parameters of TNP-2092 CapsulesHyperammonemia

COMPLETED58 Analytics

PHASE1COMPLETED

A Phase 1 Study to Evaluate PK Profile and Food Effects on PK Parameters of TNP-2092 Capsules

Hyperammonemia

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Study Endpoints

Primary Endpoints

Safety of TNP-2092 by Assessment of the Number of Participants With Adverse Events (AEs)

Up to 8 days after the first dosing.

To investigate the safety and tolerability of TNP-2092 by assessment of the number of participants with AEs. An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.

Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf) in Single Ascending Dose Study

Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration

Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma Pharmacokinetics (PK) parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.

Area Under the Plasma Concentration Versus Time Curve From 0 to the Last Measurable Concentration (AUC0-last) in Single Ascending Dose Study

Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration

Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.

Maximum Observed Plasma Concentration (Cmax) of TNP-2092 in Single Ascending Dose Study

Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration

Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.

Time to Maximum Plasma Concentration (Tmax) of TNP-2092 in Single Ascending Dose Study

Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration

Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.

Terminal Elimination Half-life (T1/2) in Single Ascending Dose Study

Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration

Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.

Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf) in Food Effect Study

Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration

Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.

Area Under the Plasma Concentration Versus Time Curve From 0 to the Last Measurable Concentration (AUC0-last) in Food Effect Study

Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration

Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.

Maximum Observed Plasma Concentration (Cmax) of TNP-2092 in Food Effect Study

Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration

Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.

Time to Maximum Plasma Concentration (Tmax) of TNP-2092 in Food Effect Study

Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration

Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.

Terminal Elimination Half-life (T1/2) in Food Effect Study

Before the first (Day1) administration (within 15 minutes), and 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 hours (h) after administration

Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.

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Study Design & Arms

AllocationRANDOMIZED

MaskingDOUBLE

ModelSEQUENTIAL

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
TNP-2092 capsules	EXPERIMENTAL	In single ascending dose study, participants received single oral dose of TNP-2092 capsules 100 to 1200 mg in fasted state. In food effect study, participants received single oral dose of TNP-2092 capsules 400 mg in fasted or fed state in a two-sequence, two-period crossover design.
Placebo	PLACEBO_COMPARATOR	In single ascending dose study, participants received single oral dose of TNP-2092 placebo capsules in fasted state. In food effect study, participants received single oral dose of TNP-2092 placebo capsules in fasted or fed state in a two-sequence, two-period crossover design.

Interventions

Name	Type	Description
TNP-2092 capsules	DRUG	Administered orally, 100 to 1200 mg
TNP-2092 placebo capsules	DRUG	Administered orally

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Eligibility Criteria

Age Range18 Years to 45 Years

SexALL

Healthy VolunteersYes

Study Sites1

Inclusion Criteria: * Sex: male or female; * Age: 18-45 years, inclusive; * BMI: 19.0-26.0 kg/m2, inclusive; * Female subjects of childbearing potential must agree to practice abstinence or take effective contraceptive measures during the study and at least 70 days (10 weeks) after administration; ...

Countries:China

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Frequently asked questions about TNP-2092

What is TNP-2092 used for?

TNP-2092 is an investigational small molecule being developed for hyperammonemia, a condition characterized by elevated ammonia levels in the blood. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes TNP-2092?

TNP-2092 is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker symbol YCBD. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetic profile.

What phase is TNP-2092 in?

TNP-2092 is in Phase 1 clinical development. A Phase 1 study has been completed, and the drug remains investigational. It has not received regulatory approval and is still undergoing clinical evaluation for hyperammonemia.

What clinical trials is TNP-2092 in?

TNP-2092 has one completed clinical trial, NCT06178718, a Phase 1 study evaluating the pharmacokinetic profile and food effects of TNP-2092 capsules. The trial enrolled 58 participants in China, including healthy volunteers, and was placebo-controlled and double-blind.

Is TNP-2092 FDA approved?

TNP-2092 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for hyperammonemia. The completed Phase 1 trial focused on pharmacokinetics and food effects, and further studies would be needed before any approval consideration.