Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TUL108 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part1: TUL108 | EXPERIMENTAL | A single ascending dose (SAD) of intravenous (IV) TUL108 (50mg\~1500mg) |
| Part1: Placebo | PLACEBO_COMPARATOR | Placebo |
| Part2: TUL108 | EXPERIMENTAL | A multiple ascending dose (MAD) of intravenous (IV) TUL108 (125 mg\~500mg q8h) |
| Part2: Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| TUL108 | DRUG | 50 mg、125 mg、250 mg、500 mg、1000 mg、1500 mg |
| Placebo | DRUG | 0.9% Sodium Chloride Injection |
Inclusion Criteria: 1. Participants must sign the informed consent form prior to the study, fully understand the study, procedures, and potential adverse reactions, and be voluntary participate in and able to complete the study as required by the protocol. 2. Male or female participants aged 18-45 ...
TUL108 is an investigational small molecule being developed for the treatment of complicated urinary tract infections (cUTI). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied for its safety, tolerability, and pharmacokinetics in healthy participants.
The molecular target of TUL108 has not been disclosed. As a small molecule intended for complicated urinary tract infections, its specific mechanism of action is not publicly detailed in the available information. The drug is currently being evaluated in early-stage clinical trials to assess its safety and pharmacokinetic profile.
TUL108 is being developed by United Therapeutics Corporation, a publicly traded biopharmaceutical company listed on NASDAQ under the ticker symbol UTHR. The company is conducting a Phase 1 clinical trial of TUL108 for complicated urinary tract infections in healthy volunteers.
TUL108 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The ongoing Phase 1 trial is designed to evaluate the safety, tolerability, and pharmacokinetics of TUL108 for injection in healthy participants, with a planned enrollment of 72 subjects.
TUL108 is being studied in a single Phase 1 clinical trial registered as NCT07719257, titled 'Evaluation of the Safety, Tolerability and Pharmacokinetics of TUL108 for Injection in Healthy Participants (SAD/MAD)'. This randomized, double-blind, placebo-controlled trial is not yet recruiting and is being conducted in China.
No alternative names for TUL108 have been reported. The drug is identified solely by its code name TUL108 in clinical trial registrations and development documentation. It is a distinct investigational compound being developed by United Therapeutics Corporation for complicated urinary tract infections.