Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-932 · 6 trials · 8 indications
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
12-lead resting ECG will be recorded.
Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
SAS (Simpson-Angus Scale): is a 10-item rating scale for assessment of antipsychotic-induced parkinsonism in both clinical practice and research settings. Minimum: 0 (no symptoms) Maximum: 40 (very severe symptoms; 10 items scored 0-4 each).
AIMS (Abnormal Involuntary Movement Scale): assesses abnormal involuntary movements, such as tardive dyskinesia, associated with antipsychotic drugs; it measures facial, oral, extremities, and trunk movements, as well as the participant's awareness of abnormal movements. Minimum: 0 (no abnormal movements) Maximum: 42 (most severe; 7 items scored 0-4 each), some versions use 0-4 on 10 items for a max of 40/40.
BARS (Barnes Akathisia Rating Scale): is a 4-item rating scale used to assess drug-induced akathisia. The scale comprises items for rating the observable restless movements that characterize the condition, the subjective awareness of restlessness, and any distress associated with the akathisia. Minimum: 0 (no akathisia) Maximum: 14 (severe akathisia; 4 items scored, most items 0-3 or 0-5)
C-SSRS rates an individual's degree of suicidal ideation (SI) and behaviors on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent."
ESS (Epworth Sleepiness Scale): is a scale that is intended to measure daytime sleepiness. Minimum: 0 (no sleepiness) Maximum: 24 (severe sleepiness; 8 items scored 0-3 each)
The YMRS (Young Mania Rating Scale): is an 11-item, clinician-rated scale that assesses manic symptoms based on the participant's perception of their condition over the previous 48 hours, as well as the physician's clinical observations during the interview. Minimum: 0 (no mania) Maximum: 60 (severe mania; 11 items, some scored 0-4, others 0-8)
Number of participants with abnormal change in ocular examinations in areas like best corrected visual acuity (BCVA), and refraction.
An AE is defined as any untoward medical occurrence in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
The HAM-A is a 14-item, clinician-reported measure used to quantify and categorize the participant's anxiety over the past week. Items are rated on a 5-point Likert rating scale. The HAM-A total score ranges from 0 to 56, with higher scores indicating greater anxiety severity.
The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.
Cmax of ABBV-932 and active metabolites DCAR and DDCAR
Tmax of ABBV-932 and active metabolites DCAR and DDCAR
Ctrough of ABBV-932 and active metabolites DCAR and DDCAR
(β) of ABBV-932 and active metabolites DCAR and DDCAR
Terminal phase elimination half-life of ABBV-932 and active metabolites DCAR and DDCAR
AUCt of ABBV-932 and active metabolites DCAR and DDCAR
AUCinf of ABBV-932 and active metabolites DCAR and DDCAR
Cmax will be assessed.
Tmax will be assessed.
Ctrough will be assessed.
AUCtau will be assessed.
Cmax of ABBV-932.
Tmax of ABBV-932.
Terminal phase elimination rate constant (beta) of ABBV-932.
Terminal phase elimination half-life of ABBV-932.
AUCt of ABBV-932.
AUCinf of ABBV-932.
Cmax of DCAR.
Tmax of DCAR.
Terminal phase elimination rate constant (beta) of DCAR.
Terminal phase elimination half-life of DCAR.
AUCt of DCAR.
AUCinf of DCAR.
Cmax of DDCAR.
Tmax of DDCAR.
Terminal phase elimination rate constant (beta) of DDCAR.
Terminal phase elimination half-life of DDCAR.
AUCt of DDCAR.
AUCinf of DDCAR.
| Arm | Type | Description |
|---|---|---|
| ABBV-932 | EXPERIMENTAL | Participants will receive oral ABBV-932 for a 26-week treatment period followed by a 30-day follow-up |
| ABBV-932 Dose A | EXPERIMENTAL | Participants will receive ABBV-932 dose A in addition to prescribed antidepressant therapies (ADTs). |
| ABBV-932 Dose B | EXPERIMENTAL | Participants will receive ABBV-932 dose B in addition to prescribed antidepressant therapies (ADTs). |
| Placebo for ABBV-932 | PLACEBO_COMPARATOR | Participants will receive placebo for ABBV-932 in addition to prescribed antidepressant therapies (ADTs). |
| ABBV-932 Dose C | EXPERIMENTAL | Participants will receive ABBV-932 Dose C. |
| ABBV-932 with Itraconazole | EXPERIMENTAL | Participants will receive ABBV-932 in Period 1 followed by Itraconalzole in combination with ABBV-932 in Period 2. |
| Part A, ABBV-932 | EXPERIMENTAL | Participants will receive ABBV-932 once daily (QD) for 14 days. |
| Part A, Placebo for ABBV-932 | EXPERIMENTAL | Participants will receive placebo for ABBV-932 QD for 14 days. |
| Part B, ABBV-932 | EXPERIMENTAL | Participants will receive ABBV-932 QD for 28 days. |
| Part B, Placebo for ABBV-932 | EXPERIMENTAL | Participants will receive placebo for ABBV-932 QD for 28 days. |
| Part C, ABBV-932 | EXPERIMENTAL | Participants will receive ABBV-932 QD for 28 days. |
| Part C, Placebo for ABBV-932 | EXPERIMENTAL | Participants will receive placebo for ABBV-932 QD for 28 days. |
| Part D, ABBV-932 | EXPERIMENTAL | Participants will receive ABBV-932 QD for 42 days. |
| Part D, Placebo for ABBV-932 | EXPERIMENTAL | Participants will receive placebo for ABBV-932 QD for 42 days. |
| Part 1: ABBV-932 | EXPERIMENTAL | Participants will receive ABBV-932 on Day 1 and followed for 30 days. |
| Part 1: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo on Day 1 and followed for 30 days. |
| Part 2: Sequence 1 | EXPERIMENTAL | Participants will receive ABBV-932 on Day 1 in Period 1 under fasting conditions and followed for 30 days. Participants will receive ABBV-932 with food on Day 1 in Period 2 and followed for 30 days. |
| Part 2: Sequence 2 | EXPERIMENTAL | Participants will receive ABBV-932 with food on Day 1 in Period 1 and followed for 30 days. Participants will receive ABBV-932 on Day 1 in Period 2 under fasting conditions and followed for 30 days. |
| Part 3: Japanese Participants: ABBV-932 | EXPERIMENTAL | Japanese participants will receive ABBV-932 on Day 1 in Period 1 and followed for 30 days. |
| Part 3: Japanese Participants: Placebo | PLACEBO_COMPARATOR | Japanese participants will receive placebo on Day 1 in Period 1 and followed for 30 days. |
| Part 3: Han-Chinese Participants: ABBV-932 | EXPERIMENTAL | Han-Chinese participants will receive placebo on Day 1 in Period 1 and followed for 30 days. |
| Name | Type | Description |
|---|---|---|
| ABBV-932 | DRUG | Oral Capsule |
| Placebo for ABBV-932 | DRUG | Oral Capsule |
| Antidepressant Therapy (ADT) | DRUG | Standard of care |
| Itraconazole | DRUG | Oral Capsule |
| Placebo | DRUG | Oral Capsule |
Inclusion Criteria: * Body Mass Index (BMI) \>= 18.0 to \<= 40.0 kg/m\^2, inclusive. * Participants who currently meet the Diagnostic and Statistical Manual of Mental Disorders treatment (DSM-5-TR) criteria for bipolar I or II disorder without psychotic features based on the Mini International Neur...
Top 10 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 4 | PHASE3 | Xanomeline and trospium chloride, Xanomeline/Trospium Chloride |
| AbbVie, Inc. | ABBV | 3 | PHASE3 | Cariprazine, ABBV-932, Icalcaprant |
| Xenon Pharmaceuticals Inc. | XENE | 2 | PHASE3 | Azetukalner |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Rapport Therapeutics, Inc. | RAPP | 1 | PHASE2 | RAP-219 |
| Neurocrine Biosciences, Inc. | NBIX | 1 | PHASE2 | NBI-1117568 |
| Alto Neuroscience, Inc. | ANRO | 1 | PHASE2 | ALTO-100 |
| LB Pharmaceuticals, Inc. | LBRX | 1 | PHASE2 | LB-102 |
| BioXcel Therapeutics, Inc. | BTAI | 1 | PHASE1 | BXCL501 |
| Alzamend Neuro, Inc. | ALZN | 1 | PHASE1 | AL001 |
ABBV-932 is an oral small molecule drug developed by AbbVie Inc. (ticker ABBV) for psychiatric conditions. It is being studied in bipolar disorder, including Bipolar I and Bipolar II disorder, and in generalized anxiety disorder. ABBV-932 remains investigational and is not approved for any indication.
ABBV-932 is being studied for bipolar disorder, including Bipolar I and Bipolar II disorder, and for generalized anxiety disorder (GAD). Trials have enrolled adults with depressive episodes associated with Bipolar I or II disorder and adults with GAD who are also taking antidepressant therapies. It is investigational and not approved for these uses.
ABBV-932 is developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie sponsors the clinical program evaluating the oral small molecule in bipolar disorder and generalized anxiety disorder.
ABBV-932 is in clinical development, with Phase 1 and Phase 2 trials conducted to date. It is investigational and has not been approved by the FDA. Studies have evaluated oral ABBV-932 in adults with bipolar disorder and generalized anxiety disorder.
ABBV-932 has been studied in several trials, including NCT06605599 in Bipolar I or II disorder, which is completed, and NCT06846320 in generalized anxiety disorder, which is recruiting. NCT07220460 in Bipolar I or II disorder is active but not recruiting, and NCT07071532 is a Phase 1 drug interaction study with itraconazole that is recruiting.
The mechanism of action for ABBV-932 has not been publicly detailed. It is an oral small molecule being evaluated in bipolar disorder and generalized anxiety disorder. Its trials assess adverse events and changes in disease activity rather than a defined molecular target.