Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Remlarsen · 1 trial · 1 indication
The percentage of subjects with confirmed keloid formation at treated versus untreated lesions at 24 weeks (± 7 days) after first dose, analyzed using the modified Vancouver Scar Scale which reports a cumulative score based on subscores for vascularity, pliability and height.
| Arm | Type | Description |
|---|---|---|
| Remlarsen - Intradermal | EXPERIMENTAL | Six doses remlarsen (5.3 mg) over a period of 2 weeks at the site of one excisional skin wound and six doses Placebo over the same period at the site of a second excisional skin wound. Each subject will serve as their own simultaneous control. |
| Placebo - Intradermal | PLACEBO_COMPARATOR | Six doses remlarsen (5.3 mg) over a period of 2 weeks at the site of one excisional skin wound and six doses Placebo over the same period at the site of a second excisional skin wound. Each subject will serve as their own simultaneous control. |
| Name | Type | Description |
|---|---|---|
| Remlarsen | DRUG | Intradermal injection at site of one excisional wound |
| Placebo | DRUG | Intradermal injection at site of second excisional wound |
Key Inclusion Criteria: * Must provide written informed consent. * Females must not be pregnant, or lactating, and have negative pregnancy tests. * Study candidates should be likely to form keloids in the upper back/shoulder area after punch biopsy based on a history of a high frequency of keloid f...
Remlarsen is an investigational small molecule being developed for the treatment of keloid, a type of raised scar. It is administered via intradermal injection and is currently in Phase 2 clinical development. Remlarsen is not yet approved and remains under investigation for this dermatological condition.
Remlarsen is being developed by CASI Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol CASI. The company is conducting clinical research to evaluate the safety and efficacy of Remlarsen for the treatment of keloids.
Remlarsen is in Phase 2 clinical development. It has completed one Phase 2 trial, and no active trials are currently listed. The drug is investigational and has not been approved by regulatory authorities for any use.
Remlarsen has been studied in one completed Phase 2 clinical trial with the identifier NCT03601052. This trial evaluated the efficacy, safety, and tolerability of Remlarsen following intradermal injection in subjects with a history of keloids. The study enrolled 14 participants in the United States.
Yes, Remlarsen is also known as MRG-201. The clinical trial NCT03601052, which evaluated Remlarsen for keloid treatment, refers to the drug as MRG-201. Both names refer to the same investigational compound being developed by CASI Pharmaceuticals.