Small Molecule · ABBV-932

ABBV-932

Phase 2Gedeon Richter Plc. (RICHTER)

Investigational oral drug discovered by Gedeon Richter and co-developed by AbbVie and Richter for neuropsychiatric disorders. ABBV-932 is a prodrug of desmethyl-cariprazine (DCAR), a dopamine D3-preferring D3/D2 receptor partial agonist and an active metabolite of Richter's marketed antipsychotic cariprazine (VRAYLAR/REAGILA). In Phase 2 for depressive episodes associated with bipolar I or II disorder and as an adjunct to antidepressants in generalized anxiety disorder. An exploratory 6-week Phase 2 bipolar depression study (161 patients) missed its primary MADRS endpoint overall, with an efficacy signal in a prespecified bipolar I subgroup and a placebo-like safety profile including extrapyramidal side effects.

Also known as: ABBV-932, RGH-932, ABBV 932

Data current as of

Key facts

Modality
Small molecule
Chemistry
Prodrug
Mechanism
D3 Partial agonist
Highest phase
Phase 2
Lead indication
Bipolar depression
Developer
Gedeon Richter Plc. (RICHTER)
Trials
6 tracked · 2 recruiting · 146 sites
Next catalyst
November 2026 — Registry results (Generalized anxiety disorder)

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.

TargetActionAffinity
D3primaryDRD3Partial agonist—ⓘ
D2DRD2Partial agonist—ⓘ

Formulations#

FormulationRouteRegimenPharmacokinetics
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).
OralOnce daily—

Development timeline#

202420252026TodayPhase 131 Aug 2023 — phase change — Multiple-dose escalation study NCT06024239 started, enrolling healthy adults plus participants with GAD and with bipolar disorder (72 enrolled; completed 2025-03-04).15 Feb 2023 — phase change — First-in-human single-ascending-dose and food-effect study NCT05738850 started (registered under GAD; healthy participants; 104 enrolled; completed 2024-05-31).Phase 230 Nov 2026 — upcoming — ClinicalTrials.gov estimated primary completion of the Phase 2 adjunctive GAD study of ABBV-932 (NCT06846320): November 2026.29 Apr 2026 — readout (missed) — 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.10 Dec 2025 — Trial (portion) completed — Phase 2 ABBV-932 bipolar depression study completed29 Apr 2025 — phase change — Phase 2 adjunctive GAD study NCT06846320 started per ClinicalTrials.gov.29 Apr 2025 — Trial started — Phase 2 study of ABBV-932 as adjunctive treatment in GAD starts31 Oct 2024 — Trial started — ABBV-932 enters Phase 2 in bipolar depression: first patient dosed15 Oct 2024 — phase change — Phase 2 placebo-controlled bipolar depression study NCT06605599 started per ClinicalTrials.gov. Richter reports the first patient was dosed on 2024-10-31.
Phase change Readout Event UpcomingHover a marker for details.
Phase 2Oct 2024 – Nov 2026
  1. UpcomingClinicalTrials.gov estimated primary completion of the Phase 2 adjunctive GAD study of ABBV-932 (NCT06846320): November 2026.Generalized anxiety disorder
  2. 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.Bipolar depression↗
  3. Trial (portion) completedPhase 2 ABBV-932 bipolar depression study completedBipolar depression
  4. Phase 2 adjunctive GAD study NCT06846320 started per ClinicalTrials.gov.Generalized anxiety disorder
  5. Trial startedPhase 2 study of ABBV-932 as adjunctive treatment in GAD startsGeneralized anxiety disorder
  6. Trial startedABBV-932 enters Phase 2 in bipolar depression: first patient dosedBipolar depression↗
  7. Phase 2 placebo-controlled bipolar depression study NCT06605599 started per ClinicalTrials.gov. Richter reports the first patient was dosed on 2024-10-31.Bipolar depression
Phase 1Feb 2023 – Aug 2023
  1. Multiple-dose escalation study NCT06024239 started, enrolling healthy adults plus participants with GAD and with bipolar disorder (72 enrolled; completed 2025-03-04).Bipolar depression
  2. First-in-human single-ascending-dose and food-effect study NCT05738850 started (registered under GAD; healthy participants; 104 enrolled; completed 2024-05-31).Generalized anxiety disorder

ABBV-932 for Bipolar depression#

Phase 2ActiveBipolar depression indication →

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.

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. ↗

ABBV-932 for Generalized anxiety disorder#

Phase 2RecruitingGeneralized anxiety disorder indication →

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.

Readouts

  • November 2026AnticipatedRegistry resultsNCT06846320

    ClinicalTrials.gov estimated primary completion of the Phase 2 adjunctive GAD study of ABBV-932 (NCT06846320): November 2026.

Clinical trials#

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

Started Aug 2026· Primary completion Feb 2027

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

Started Sept 2025· Primary completion Mar 2027· 49 sites across 2 countries

United StatesPuerto Rico

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

Started Apr 2025· Primary completion Nov 2026· 52 sites across 2 countries

United StatesPuerto Rico

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

Started Oct 2024· Primary completion Nov 2025· 40 sites across 3 countries

United StatesJapanPuerto Rico

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

Started Aug 2023· Primary completion Mar 2025· 3 sites across 1 country

United States

Show all 6 trials

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

Started Feb 2023· Primary completion May 2024· 2 sites across 1 country

United States

Sources#

  1. Gedeon Richter Q3 2024 results presentation — Gedeon Richter Plc. (via Budapest Stock Exchange)
  2. M23-991: Open-Label PET Study to Evaluate Dopamine Receptor occupancy after doses of ABBV-932 (research summary) — NHS Health Research Authority
  3. NCT05738850: First-in-human SAD and food-effect study of ABBV-932 — ClinicalTrials.gov
  4. NCT06024239: Multiple-dose escalation study of ABBV-932 — ClinicalTrials.gov
  5. NCT06605599: Phase 2 ABBV-932 in bipolar I/II depression — ClinicalTrials.gov
  6. NCT06846320: Phase 2 ABBV-932 adjunctive to antidepressants in GAD — ClinicalTrials.gov
  7. NCT07071532: Itraconazole DDI study of ABBV-932 in bipolar disorder — ClinicalTrials.gov
  8. NCT07220460: Open-label long-term safety of ABBV-932 in bipolar depression — ClinicalTrials.gov
  9. 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)