ABBV-932 · program
ABBV-932 for Generalized anxiety disorder
Indications for ABBV-932: Bipolar depression · Phase 2 Generalized anxiety disorder · Phase 2
ABBV-932 (RGH-932), an oral prodrug of the D3-preferring D3/D2 partial agonist desmethyl-cariprazine, as an adjunct to antidepressant therapy in adults with generalized anxiety disorder who have had an inadequate response to antidepressants. The randomized, double-blind, placebo-controlled, fixed-dose Phase 2 study (NCT06846320) plans about 315 participants at about 50 US and Puerto Rico sites. It tests two doses of ABBV-932 or placebo added to current antidepressant therapy for 6 weeks, with change in HAM-A total score as the efficacy primary endpoint. The study is recruiting, with ClinicalTrials.gov estimating primary completion in November 2026.
Development timeline
- UpcomingClinicalTrials.gov estimated primary completion of the Phase 2 adjunctive GAD study of ABBV-932 (NCT06846320): November 2026.
- Phase 2 adjunctive GAD study NCT06846320 started per ClinicalTrials.gov.
- Trial startedPhase 2 study of ABBV-932 as adjunctive treatment in GAD starts
- First-in-human single-ascending-dose and food-effect study NCT05738850 started (registered under GAD; healthy participants; 104 enrolled; completed 2024-05-31).
Readouts
- November 2026AnticipatedRegistry resultsNCT06846320
ClinicalTrials.gov estimated primary completion of the Phase 2 adjunctive GAD study of ABBV-932 (NCT06846320): November 2026.
Clinical trials in Generalized anxiety disorder
NCT06846320M25-099Phase 2Recruitingn=315
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose Study to Evaluate the Efficacy, Safety, and Tolerability of ABBV-932 as an Adjunct to Antidepressant Therapies in the Treatment of Subjects With Generalized Anxiety Disorder Who Have Had an Inadequate Response to Antidepressant Therapies
NCT06024239M23-893Phase 1Completedn=72
A Multiple Dose Escalation Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of ABBV-932 in Healthy Adult Subjects, Subjects With Generalized Anxiety Disorder (GAD) and Subjects With Bipolar Disorder
NCT05738850M23-889Phase 1Completedn=104
Generalized Anxiety Disorder (GAD): A First-in-Human Single Ascending Dose and Food Effect Study of ABBV-932 in Healthy Adult Subjects
Formulations
| Formulation | Route | Regimen | Pharmacokinetics |
|---|---|---|---|
| ABBV-932 oral capsule (once daily) Oral capsules once daily in Phase 2 (bipolar depression: three undisclosed fixed doses, labelled Dose A/B/C on ClinicalTrials.gov, for 6 weeks; GAD: two undisclosed fixed doses added to antidepressant therapy). An oral tablet was compared with the capsule in a Phase 1 relative-bioavailability study (NCT06849791). | Oral | Once daily | — |
Mechanism of action
ABBV-932 is a prodrug of desmethyl-cariprazine (DCAR), a dopamine D3 receptor-preferring D3/D2 receptor partial agonist. DCAR and didesmethyl-cariprazine (DDCAR), both known active metabolites of cariprazine, are measured as analytes in the ABBV-932 Phase 1 pharmacokinetic studies. Brain D2 and D3 receptor occupancy after multiple doses was assessed by PET in healthy volunteers (NCT06300580); no occupancy or binding values have been published.
| Target | Action | Affinity |
|---|---|---|
| D3primaryDRD3 | Partial agonist | —ⓘ |
| D2DRD2 | Partial agonist | —ⓘ |
← Full ABBV-932 compound page (identity, identifiers, all indications)
Sources
- M23-991: Open-Label PET Study to Evaluate Dopamine Receptor occupancy after doses of ABBV-932 (research summary) — NHS Health Research Authority
- NCT05738850: First-in-human SAD and food-effect study of ABBV-932 — ClinicalTrials.gov
- NCT06024239: Multiple-dose escalation study of ABBV-932 — ClinicalTrials.gov
- NCT06605599: Phase 2 ABBV-932 in bipolar I/II depression — ClinicalTrials.gov
- NCT06846320: Phase 2 ABBV-932 adjunctive to antidepressants in GAD — ClinicalTrials.gov