Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Litapiprant · 1 trial · 1 indication
To assess the safety and tolerability after a single dose of Litapiprant Tablets
| Arm | Type | Description |
|---|---|---|
| 25mg single doses | PLACEBO_COMPARATOR | Intervention Drug: 25mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily |
| 50mg single doses | PLACEBO_COMPARATOR | Intervention Drug: 50mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily |
| 100mg single doses | PLACEBO_COMPARATOR | Intervention Drug: 100mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily |
| 200mg single doses | PLACEBO_COMPARATOR | Intervention Drug: 200mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily |
| 400mg single doses | PLACEBO_COMPARATOR | Intervention Drug: 400mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily |
| 600mg single doses | PLACEBO_COMPARATOR | Intervention Drug: 600mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily |
| 800mg single doses | PLACEBO_COMPARATOR | Intervention Drug: 800mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily |
| Name | Type | Description |
|---|---|---|
| Litapiprant Tablet | DRUG | Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells |
Inclusion Criteria: * Male or female, overall healthy subjects，female VS male 1:1 ratio; * Between 18 and 45 years of age, inclusive, similar ages; * Body weight should be≥50 kg; Body Mass Index (BMI) is between 19.0 and 28.0 kg/m2, inclusive; * Able to comprehend and sign the ICF voluntarily prior...
Litapiprant is an investigational small molecule being developed for the treatment of asthma. 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 pharmacokinetic profile in healthy subjects.
Litapiprant is being developed by Sunshine Biopharma Inc., a company listed on the stock exchange under the ticker symbol SBFM. The company is conducting clinical trials to evaluate the drug's safety and tolerability in healthy volunteers.
Litapiprant is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing.
Litapiprant has one completed Phase 1 clinical trial registered under NCT03663686. The study, titled "The Safety, Tolerability and Pharmacokinetic Study of Litapiprant Tablets in Healthy Male and Female Subjects," enrolled 60 participants in China. It was a randomized, double-blind, placebo-controlled trial.
No, Litapiprant is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial focused on safety, tolerability, and pharmacokinetics in healthy volunteers, and further studies are needed before any approval can be considered.