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| US Clinical Trail Options | |||
| Field(s): | Type(s): | Status(es): | Phase(s): |
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| US FDA Submission Options | |||
| Field(s): | Class(s): | Type(s): | |
| US Drug Marketing Status Options | |||
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| EU Drug Marketing Status Options | |||
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| CA Drug Marketing Status Options | |||
| Field(s): | |||
| General Options | |||
| Historical Years: | Display Records Number: | ||
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| Price Chart: | Technical Indicators: | Clinical Trails: | FDA Submissions: |
| US Marketing: | EU Marketing: | CA Marketing: |
| Full Name:Axsome Therapeutics Inc. | Industry:pharmaceuticals | CIK:1579428 | Fiscal Year End:12-31 | State/Country:NEW YORK |
Check Quant Chart for other overlays (E.g. SEC filings, Insider tradings) to get more accurate projection of price movement
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Instructions
US clinical trial status
Size of symbol reflects the phase of clinical trial. E.g. Phase 3 trial has the largest size.
Shape definition
▲ Up-triangle: study first submitted.
◼ Square: study completion(actual/anticipated).
⬤ Circle: result first posted.
Color definition
▶ Green: study is ongoing.
▶ Blue: recruitment completed.
▶ Red: study aborted/terminated/withdrawn.
▶ Pink: study in abnormal state.
US FDA submission
Size of symbol reflects the type of submission. E.g. Type 1 drug has the largest size.
◆: Approved.
◆: Tentative Approval.
Drug marketing & current status
Circle bubble denotes new drug marketing. Size is determined by drug type and market(i.e. population) size. E.g. Type 1 drug marketed in US has the largest size. Drug marketed in CA has the smallest size due to small population size.
Color definition
⬤ Blue circle: drug marketed (EU,CA), FDA submission approved (US).
⬤ Cyan circle: drug approved (CA), tentative approval (US), received positive opinion (EU)
⬤ Red circle: drug marketed/approved on the corresponding day but was later withdrawn, discontinued, cancelled, or received negative opinion.
Drug marketing status change
Square bubble denotes marketing status change. Size is determined by drug type and market(i.e. population) size.
Color definition
◼ Blue square: change from other status to marketed.
◼ Cyan square: change from other status to tentative status.
◼ Red square: change from other status to abnormal or withdrawn status.
Clinical Trials Summary Statistics
| Year | Recruiting | Enrolling By Invitation | Active, Not Recruiting | Completed | Unknown Status |
|---|---|---|---|---|---|
| ALL | 1 | ||||
| 2024 | |||||
| 2023 | |||||
| 2022 |
| Year | Recruiting | Enrolling By Invitation | Active, Not Recruiting | Completed | Unknown Status |
|---|---|---|---|---|---|
| ALL | 1 | 4 | |||
| 2024 | |||||
| 2023 | |||||
| 2022 |
| Year | Recruiting | Enrolling By Invitation | Active, Not Recruiting | Completed | Unknown Status |
|---|---|---|---|---|---|
| ALL | 1 | ||||
| 2024 | |||||
| 2023 | |||||
| 2022 |
| Year | Recruiting | Enrolling By Invitation | Active, Not Recruiting | Completed | Unknown Status |
|---|---|---|---|---|---|
| ALL | 4 ⬤ | 2 ⬤ | 1 | 8 ⬤ | 1 |
| 2024 | 1 ⬤ | ||||
| 2023 | 1 ⬤ | ||||
| 2022 | 2 ⬤ |
| Year | Recruiting | Enrolling By Invitation | Active, Not Recruiting | Completed | Unknown Status |
|---|---|---|---|---|---|
| ALL | 1 | 1 | |||
| 2024 | 1 | ||||
| 2023 | |||||
| 2022 |
| Year | Phase 1 | Phase 2 | Phase 2|Phase 3 | Phase 3 | Phase 4 |
|---|---|---|---|---|---|
| ALL | 4 ⬤ | 1 | |||
| 2024 | 1 ⬤ | 1 | |||
| 2023 | 1 ⬤ | ||||
| 2022 | 2 ⬤ |
| Year | Phase 1 | Phase 2 | Phase 2|Phase 3 | Phase 3 | Phase 4 |
|---|---|---|---|---|---|
| ALL | 1 | 2 ⬤ | |||
| 2024 | |||||
| 2023 | |||||
| 2022 |
| Year | Phase 1 | Phase 2 | Phase 2|Phase 3 | Phase 3 | Phase 4 |
|---|---|---|---|---|---|
| ALL | 1 | ||||
| 2024 | |||||
| 2023 | |||||
| 2022 |
| Year | Phase 1 | Phase 2 | Phase 2|Phase 3 | Phase 3 | Phase 4 |
|---|---|---|---|---|---|
| ALL | 1 | 4 | 1 | 8 ⬤ | 1 |
| 2024 | |||||
| 2023 | |||||
| 2022 |
| Year | Phase 1 | Phase 2 | Phase 2|Phase 3 | Phase 3 | Phase 4 |
|---|---|---|---|---|---|
| ALL | 1 | ||||
| 2024 | |||||
| 2023 | |||||
| 2022 |
| Phase | Recruiting | Enrolling By Invitation | Active, Not Recruiting | Completed | Unknown Status |
|---|---|---|---|---|---|
| Phase 1 | 1 | ||||
| Phase 2 | 1 | 4 | |||
| Phase 2|Phase 3 | 1 | ||||
| Phase 3 | 4 ⬤ | 2 ⬤ | 1 | 8 ⬤ | 1 |
| Phase 4 | 1 | 1 |
| Phase | Recruiting | Enrolling By Invitation | Active, Not Recruiting | Completed | Unknown Status |
|---|---|---|---|---|---|
| Phase 1 | |||||
| Phase 2 | |||||
| Phase 2|Phase 3 | |||||
| Phase 3 | 1 ⬤ | ||||
| Phase 4 | 1 |
| Phase | Recruiting | Enrolling By Invitation | Active, Not Recruiting | Completed | Unknown Status |
|---|---|---|---|---|---|
| Phase 1 | |||||
| Phase 2 | |||||
| Phase 2|Phase 3 | |||||
| Phase 3 | 1 ⬤ | ||||
| Phase 4 |
| Phase | Recruiting | Enrolling By Invitation | Active, Not Recruiting | Completed | Unknown Status |
|---|---|---|---|---|---|
| Phase 1 | |||||
| Phase 2 | |||||
| Phase 2|Phase 3 | |||||
| Phase 3 | 2 ⬤ | ||||
| Phase 4 |
Note: "Year" represents clinical trail start year determined by study first submit date.
Three grouping strategies present the same statistical data from different angles, choose any one you are comfortable with.
⬤ at least one study with latest update posted within 7 days.
⬤ at least one study with latest update posted within 30 days.
⬤ at least one study with latest update posted within 90 days.
Clinical Trials Records
| Sponsor | Overall Status | Phase | Brief Title | Disease Condition | Intervention Name | Study First Submit Date | Last Update Post Date | Results First Post Date | Completion Date | Completion Date Type | Enrollment Count |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Axsome Therapeutics, Inc. | Recruiting | Phase 3 | Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol | Major Depressive Disorder | Solriamfetol 300 mg|Placebo | 2024-04-08 | 2024-04-11 | 2025-12-01 | Anticipated | 300 | |
| Axsome Therapeutics, Inc. | Recruiting | Phase 3 | A Study to Access the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS) | ADHD | Solriamfetol 150 mg|Solriamfetol 300 mg|Placebo | 2023-07-25 | 2024-04-26 | 2024-12-01 | Anticipated | 450 | |
| Axsome Therapeutics, Inc. | Recruiting | Phase 3 | A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation | Agitation in Patients With Dementia of the Alzheimer's Type|Alzheimer Disease|Agitation | AXS-05|Placebo | 2022-09-23 | 2024-04-26 | 2025-06-01 | Anticipated | 350 | |
| Axsome Therapeutics, Inc. | Recruiting | Phase 3 | Open-Label Study of AXS-07 for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor (EMERGE) | Migraine | AXS-07 (meloxicam-rizatriptan) | 2022-09-19 | 2024-04-26 | 2024-12-01 | Anticipated | 100 |
Note: Use 'Search' box on top right cornor to narrow down search results. E.g. type in "phase 3" (case insensitive, with double quote) to show Phase 3 trials.
⬤ latest update posted within 7 days.
⬤ latest update posted within 30 days.
⬤ latest update posted within 90 days.
US FDA Submission Summary Statistics*
| Year | TYPE 1 | TYPE 3/4 |
|---|---|---|
| ALL | 1 | 1 |
| 2024 | ||
| 2023 | ||
| 2022 | 1 |
Note: "Year" determined by submission status date.
* Original submissions only. Supplementary records not counted.
⬤ at least one submission within 7 days.
⬤ at least one submission within 30 days.
⬤ at least one submission within 90 days.
US FDA Submission Records
| Sponsor | Application Type | Drug Name | Active Ingredient | Submission Code | Submission Type | Submission Status | Status Date | Application Number |
|---|---|---|---|---|---|---|---|---|
| Axsome | NDA | Auvelity | Bupropion Hydrochloride; Dextromethorphan Hydrobromide | Type 3/4 | Orig | Approval | 2022-08-18 | 215430 |
Note: Use 'Search' box on top right cornor to narrow down search results. E.g. type in "NDA" (case insensitive) to show records with "NDA" (New Drug Applications) tag.
⬤ submission status date within 7 days.
⬤ submission status date within 30 days.
⬤ submission status date within 90 days.
| Category | Sponsor | Marketing Date | Current Marketing Status | Drug Name | Active Ingredient | Submission Status Date | Submission Code | Submission Status | Marketing Status Change Date |
|---|---|---|---|---|---|---|---|---|---|
| Human Non-Bioproduct | Axsome | 2022-08-18 | Prescription | Auvelity | Bupropion Hydrochloride; Dextromethorphan Hydrobromide | 2022-08-18 | Type 3/4 | Approval | 2023-11-30 |
Note: This table contains human and animal drugs regulated by US FDA, and biological products regulated by CBER (Center for Biologics Evaluation and Research).
Use 'Search' box on top right cornor to narrow down search results. E.g. type in "discontinued" (case insensitive) to show discontinued drug products.
For human non-bioproduct, marketing date was set to submission approval date.
Possible marketing statuses: Marketed, Prescription, Over-the-counter, Discontinued, None (Tentative Approval).
⬤ any of (marketing/submission/status change) within 7 days.
⬤ any of (marketing/submission/status change) within 30 days.
⬤ any of (marketing/submission/status change) within 90 days.
No marketed drug found matching current filtering criteria
Note: This table contains human and animal drugs regulated by EMA (European Medicines Agency), and summary of opinion published by EMA based on the CHMP's or CVMP's positive or negative recommendation.
Use 'Search' box on top right cornor to narrow down search results. E.g. type in "withdrawn" (case insensitive) to show drugs withdrawn.
Possible marketing statuses: Authorised, Refused, Withdrawn, Summary of Opinion.
Summary of Opinion: published by European Medicines Agency (EMA) based on the CHMP's or CVMP's positive or negative recommendation. Further marketing authorization is partially based on this opinion.
⬤ any of (authorization/withdrawn/opinion/status change) date within 7 days.
⬤ any of (authorization/withdrawn/opinion/status change) date within 30 days.
⬤ any of (authorization/withdrawn/opinion/status change) date within 90 days.
| Category | Sponsor | Authorization Date | Current Marketing Status | Status Date | Drug Name | Active Ingredient |
|---|---|---|---|---|---|---|
| Human | Axsome Malta Ltd. | 2021-05-13 | Marketed | 2022-11-17 | Sunosi | Solriamfetol (Solriamfetol Hydrochloride) (75 Mg) |
| Human | Axsome Malta Ltd. | 2021-05-13 | Marketed | 2022-11-17 | Sunosi | Solriamfetol (Solriamfetol Hydrochloride) (150 Mg) |
Note: This table contains human, animal drugs, radiopharmaceutical and disinfectant regulated by CFIA(Canadian Food Inspection Agency) and Health Canada.
Use 'Search' box on top right cornor to narrow down search results. E.g. type in "marketed" (case insensitive) to show drugs marketed.
Possible marketing statuses: Marketed, Approved, Dormant, Cancelled Pre Market, Cancelled Post Market, Cancelled (Safety Issue), Cancelled (Unreturned Annual).
⬤ any of (authorization/status change) date within 7 days.
⬤ any of (authorization/status change) date within 30 days.
⬤ any of (authorization/status change) date within 90 days.