Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MRG-201
Remlarsen · 2 trials · 2 indications
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. |
| MRG-201 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Remlarsen | DRUG | Intradermal injection at site of one excisional wound |
| Placebo | DRUG | Intradermal injection at site of second excisional wound |
| MRG-201 | DRUG | Intradermal injection of single ascending doses and multiple ascending doses in healthy volunteers. |
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 RNA therapy being studied for the treatment of keloids, which are raised scars that grow beyond the original wound site. It is being developed by CASI Pharmaceuticals, Inc. and has been evaluated in a Phase 2 clinical trial in subjects with a history of keloids.
Remlarsen is an antisense oligonucleotide, a type of RNA therapy. It is designed to target RNA to modulate gene expression. This mechanism is intended to interfere with the biological pathways involved in keloid formation, though the specific molecular target has not been publicly disclosed.
Remlarsen is being developed by CASI Pharmaceuticals, Inc., which trades under the ticker symbol CASI. The company is responsible for the clinical development of the drug, including the completed Phase 2 trial in keloids.
Remlarsen is in Phase 2 clinical development. A Phase 2 trial has been completed, and the drug remains investigational. It has not been approved by the FDA for any indication.
Remlarsen has been studied in one clinical trial: NCT03601052, titled 'Efficacy, Safety, and Tolerability of Remlarsen (MRG-201) Following Intradermal Injection in Subjects With a History of Keloids.' This Phase 2 trial was completed and enrolled 14 participants in the United States.
Yes, Remlarsen is also known as MRG-201. The clinical trial for Remlarsen refers to it as MRG-201, and both names refer to the same investigational RNA therapy being developed by CASI Pharmaceuticals for keloids.