ABBV-932 · program
ABBV-932 for Bipolar depression
Indications for ABBV-932: Bipolar depression · Phase 2 Generalized anxiety disorder · Phase 2
ABBV-932 (RGH-932), an oral once-daily prodrug of the D3-preferring D3/D2 partial agonist desmethyl-cariprazine, for depressive episodes associated with bipolar I or II disorder. Co-developed by AbbVie and Gedeon Richter. A randomized, double-blind, placebo-controlled, fixed-dose 6-week Phase 2 study (NCT06605599; 161 patients; three dose levels vs placebo) did not reach statistical significance on the primary endpoint, change in MADRS total score at Week 6, across all patients. An efficacy signal was seen in a prespecified bipolar I subgroup, and the safety profile was generally similar to placebo, including extrapyramidal side effects. Richter reported in April 2026 that next steps in bipolar I depression are under evaluation. A 26-week open-label safety study (NCT07220460) is active but no longer recruiting, and a Phase 1 drug-interaction study in patients with bipolar disorder is recruiting.
Development timeline
- missedPhase 2 ABBV-932 bipolar depression study misses its primary MADRS endpoint overall, with an efficacy signal in the prespecified bipolar I subgroup and a placebo-like safety profile.↗
- Trial (portion) completedPhase 2 ABBV-932 bipolar depression study completed
- Phase 2 placebo-controlled bipolar depression study NCT06605599 started per ClinicalTrials.gov. Richter reports the first patient was dosed on 2024-10-31.
- Multiple-dose escalation study NCT06024239 started, enrolling healthy adults plus participants with GAD and with bipolar disorder (72 enrolled; completed 2025-03-04).
Readouts
- 2026-04-29ReportedTopline datamissedNCT06605599
Phase 2 ABBV-932 bipolar depression study misses its primary MADRS endpoint overall, with an efficacy signal in the prespecified bipolar I subgroup and a placebo-like safety profile. ↗
Clinical trials in Bipolar depression
NCT07071532M24-966Phase 1Recruitingn=20
A Phase 1 Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of ABBV-932 in Adult Subjects With Bipolar Disorder
NCT07220460M25-456Phase 2Activen=84
Multicenter, Open-label Study to Evaluate the Long-term Safety and Tolerability of ABBV-932 in Subjects With Depressive Episodes Associated With Bipolar I or II Disorder
NCT06605599M23-894Phase 2Completedn=161
Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Fixed-dose Study to Evaluate the Efficacy, Safety, and Tolerability of ABBV-932 in Subjects With Depressive Episodes Associated With Bipolar I or II Disorder
missedprimaryChange from baseline to Week 6 in MADRS total score vs placebo (three fixed doses)
The overall drug-placebo difference was not statistically significant. A prespecified bipolar I subgroup analysis showed an efficacy signal. ABBV-932 was generally safe and well tolerated at all doses, with a safety profile generally similar to placebo, including extrapyramidal side effects. Effect sizes and p-values were not disclosed.
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
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
- Gedeon Richter Q3 2024 results presentation — Gedeon Richter Plc. (via Budapest Stock Exchange)
- M23-991: Open-Label PET Study to Evaluate Dopamine Receptor occupancy after doses of ABBV-932 (research summary) — NHS Health Research Authority
- NCT06024239: Multiple-dose escalation study of ABBV-932 — ClinicalTrials.gov
- NCT06605599: Phase 2 ABBV-932 in bipolar I/II depression — ClinicalTrials.gov
- NCT07071532: Itraconazole DDI study of ABBV-932 in bipolar disorder — ClinicalTrials.gov
- NCT07220460: Open-label long-term safety of ABBV-932 in bipolar depression — ClinicalTrials.gov
- Update on Phase II study of ABBV-932 (RGH-932) for the treatment of bipolar depression (2026-04-29) — Gedeon Richter Plc. (via Budapest Stock Exchange)