Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ABBV-1354, CVL-354
Icalcaprant · 4 trials · 5 indications
MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Total score ranges from 0 (no depression) to 60 (severely depressed).
An adverse event (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. The investigator assesses the relationship of each event to the use of study
Montgomery-Åsberg Depression Rating Scale (MADRS) The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are to be rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item will be scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.
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 physical examinations in areas like cardiovascular, respiratory, gastrointestinal, and neurological systems will be assessed.
Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
Cmax of ABBV-1354 will be assessed.
Max of ABBV-1354 will be assessed.
Terminal phase elimination half-life (t1/2) of ABBV-1354 will be assessed.
AUCt of ABBV-1354 will be assessed.
AUCinf of ABBV-1354 will be assessed.
Amount of ABBV-1354 excreted in the urine over the sampling period (Aeu) will be assessed.
Percent excreted = 100 × (Aeu/dose).
Amount of ABBV-1354 excreted in the feces over the sampling period (Aeu) will be assessed.
Percent excreted = 100 × (Aeu/dose).
| Arm | Type | Description |
|---|---|---|
| Group 1: Icalcaprant Dose A | EXPERIMENTAL | Participants will receive oral Icalcaprant dose A once daily for 6 weeks and followed for 4 weeks. |
| Group 2: Icalcaprant Dose B | EXPERIMENTAL | Participants will receive oral Icalcaprant dose B once daily for 6 weeks and followed for 4 weeks. |
| Group 3: Placebo for Icalcaprant | PLACEBO_COMPARATOR | Participants will receive oral placebo for Icalcaprant daily for 6 weeks and followed for 4 weeks. |
| Icalcaprant Dose A | EXPERIMENTAL | Participants will receive oral Icalcaprant dose A once daily for 6 weeks and attend a follow up visit 30 days following end of treatment. |
| Icalcaprant Dose B | EXPERIMENTAL | Participants will receive oral Icalcaprant dose B once daily for 6 weeks and attend a follow up visit 30 days following end of treatment. |
| Placebo for Icalcaprant | PLACEBO_COMPARATOR | Participants will receive oral placebo once daily for 6 weeks and attend a follow up visit 30 days following end of treatment. |
| ABBV-1354 | EXPERIMENTAL | Participants will receive a single dose of oral ABBV-1354 and followed 30 days post dose. |
| Name | Type | Description |
|---|---|---|
| Icalcaprant | DRUG | Oral Capsules |
| Placebo for Icalcaprant | DRUG | Oral Capsules |
| CVL-354 | DRUG | Oral solution/capsule |
| [11C]-LY2795050 | DRUG | IV injection |
| [11C]-carfentanil | DRUG | IV injection |
| ABBV-1354 | DRUG | Oral solution |
Inclusion Criteria: * Participants with a diagnosis of bipolar I or II according to the DSM-5-TR without psychotic features, confirmed by the MINI 7.0.2, and currently experiencing an MDE beginning at least 4 weeks prior to consent and not exceeding 12 months prior to Screening. * Body Mass Index (...
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 |
Icalcaprant is an investigational oral small molecule being developed by AbbVie Inc. for psychiatric conditions. It is in Phase 2 clinical development for Major Depressive Disorder and Bipolar I Disorder. It has not been approved by the FDA and remains under clinical study.
Icalcaprant is being studied for the treatment of Major Depressive Disorder and Bipolar I Disorder, including Bipolar II Disorder in one trial. It is an investigational therapy and is not approved for any indication. All use is currently limited to participation in clinical research.
Icalcaprant is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical trials evaluating the drug in Major Depressive Disorder and Bipolar I Disorder.
Icalcaprant is in Phase 2 clinical development. Both of its trials are Phase 2 studies that are currently recruiting adult participants. The drug is investigational and has not received FDA approval for any indication.
Icalcaprant is being evaluated in two Phase 2 trials. NCT07276997 is a placebo-controlled study in adults with Major Depressive Disorder. NCT06696755 is a placebo-controlled study in adults with Bipolar I or II Disorder. Both are randomized, double-blind, and recruiting in the United States.
The Icalcaprant clinical program has a total planned enrollment of 195 participants across its studies. The Phase 2 trial in Major Depressive Disorder and the Phase 2 trial in Bipolar I or II Disorder each list 195 participants. Both trials enroll adults aged 18 years and older.