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Also known as SAD Dose 1- ABS201 Single Dose, ABS-201 SC Multiple Doses, ABS-201 Multiple Doses
ABS-201 · 1 trial · 2 indications
Safety assessments based on reporting of Treatment Emergent Adverse Events, together with clinically significant changes in vital signs, 12-lead ECG parameters, physical examination findings and clinical safety laboratory tests, and change in neurobehavioral symptoms (PHQ-9 and GAD-7).
| Arm | Type | Description |
|---|---|---|
| SAD IV Dose 1 - 150mg ABS201 or Placebo | EXPERIMENTAL | ABS-201 IV Single Dose |
| SAD IV Dose 2 - 450mg ABS201 or Placebo | EXPERIMENTAL | Single Intra-venous dose of active study drug or placebo in Healthy Volunteers |
| SAD IV Dose 3 - 900mg ABS201 or Placebo | EXPERIMENTAL | Single Intra-venous dose of active study drug or placebo in Healthy Volunteers |
| SAD IV Dose 4 - 1800mg ABS201 or Placebo | EXPERIMENTAL | Single Intra-venous dose of active study drug or placebo in Healthy Volunteers |
| MAD SC Dose 1 - 300mg ABS201 or Placebo | EXPERIMENTAL | Multiple Ascending Doses of active study drug or placebo delivered subcutaneously in Patients with AGA |
| MAD SC Dose 2 - 600mg ABS201 or Placebo | EXPERIMENTAL | Multiple Ascending Doses of active study drug or placebo delivered subcutaneously in Patients with AGA |
| MAD SC Dose 2 - 1200mg ABS201 or Placebo | EXPERIMENTAL | Multiple Ascending Doses of active study drug or placebo delivered subcutaneously in Patients with AGA |
| Name | Type | Description |
|---|---|---|
| SAD IV Dose 1 - 150mg ABS201 IV Single Dose | DRUG | ABS-201 is an IgG1 monoclonal antibody developed to specifically target the prolactin receptor (PRLR) |
| Placebo IV | DRUG | Matching placebo |
| ABS-201 SC Multiple Doses | DRUG | Multiple doses of ABS-201 for Subcutaneous injection |
| Placebo SC Injection | DRUG | Subcutaneous Placebo injection for MAD arms |
Inclusion Criteria (Major): * Participants must be overtly healthy, as determined by medical evaluation, which includes a review of medical and surgical history, physical examination, and a 12-lead ECG. * Must have normal ranges for hematology, clinical chemistry, coagulation tests, and urine analy...
ABS-201 is an investigational small molecule being developed by Absci Corporation for androgenetic alopecia, a common form of hair loss. It is in Phase 1 clinical development and has not been approved by the FDA. It is being studied in both healthy volunteers and adults with androgenetic alopecia.
ABS-201 is being developed for androgenetic alopecia, also known as AGA. The Phase 1 trial enrolls adults with and without androgenetic alopecia, including healthy male and female volunteers. Because it remains investigational, ABS-201 is not currently approved for any indication.
ABS-201 is developed by Absci Corporation, which trades on the Nasdaq under the ticker ABSI. Absci is the sponsor of the Phase 1 study evaluating the drug in adults with and without androgenetic alopecia.
ABS-201 is in Phase 1 clinical development. Its single trial is a Phase 1 study of single and multiple ascending doses in adults with and without androgenetic alopecia, and it is currently recruiting participants. ABS-201 has not been approved by the FDA.
ABS-201 is being studied in one Phase 1 trial, NCT07317544, titled Study of ABS-201 Evaluating Single and Multiple Ascending Doses in Adults With and Without Androgenetic Alopecia. The trial is recruiting 227 participants in Australia, is randomized, double blind, and controlled, and enrolls adults aged 18 years and older.
Yes, ABS-201 and ABS201 refer to the same investigational drug from Absci Corporation. Trial listings also describe it by dose cohorts, including SAD IV Dose 1 - 150mg ABS201 IV Single Dose, SAD Dose 1 - ABS201 Single Dose, ABS-201 SC Multiple Doses, and ABS-201 Multiple Doses.