Approval Probability
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AMG 691 · 1 trial · 1 indication
An adverse event (AE) is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurred after the participant received study treatment. Serious AEs (SAEs) are defined as any untoward medical occurrence that, meet at least 1 of the following serious criteria: Immediately life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect. Includes AEs of interest (AEOI), and AEs leading to discontinuation.
| Arm | Type | Description |
|---|---|---|
| Part A: Single Ascending Dose (SAD) | EXPERIMENTAL | Healthy participants will be randomized in a 3:1 ratio to receive either AMG 691 or placebo. |
| Part B: Multiple Ascending Dose (MAD) | EXPERIMENTAL | Healthy participants will be randomized in a 3:1 ratio to receive either AMG 691 or placebo. |
| Part C: Multiple Dose | EXPERIMENTAL | Participants with mild-to-moderate asthma will be randomized in a 2:1 ratio to receive either AMG 691 or placebo. |
| Name | Type | Description |
|---|---|---|
| AMG 691 | DRUG | Subcutaneous (SC) injection |
| Placebo | DRUG | SC injection |
Inclusion Part A and B * Participants must be capable of giving informed consent and have provided informed consent. * Participants must be 18 to 65, inclusive at time of signing of informed consent. * Participants must have a Body Mass Index between 18.0 to 30 kg/m\^2 and total body weight ≥ 40 kg...
Top 16 of 18 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 5 | PHASE3 | QVM149, QMF149, Glycopyrronium bromide |
| GSK plc Sponsored ADR | GSK | 10 | PHASE3 | Trelegy Ellipta, Depemokimab, HFA-152a, GSK5784283, Ventolin |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 4 | PHASE3 | TEV-56248, ProAir (albuterol sulfate eMDPI), Budesonide/Formoterol SPIROMAX, Reslizumab |
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Dupilumab, Lunsekimig |
| AstraZeneca PLC | AZN | 27 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | tilrekimig and rHuPH20, PF-07275315, PF-08103402 |
| Generate Biomedicines, Inc. | GENB | 3 | PHASE3 | GB-0895 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Incyte Corporation | INCY | 1 | PHASE2 | povorcitinib |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE2 | ARO-RAGE |
| Amgen Inc. | AMGN | 1 | PHASE1 | AMG 691 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Apogee Therapeutics, Inc. | APGE | 1 | PHASE1 | APG777 |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE1 | CDX-622 |
AMG 691 is an investigational small molecule drug being developed by Amgen Inc. for asthma, a respiratory condition. It is in Phase 1 clinical development and has not been approved for any use. Amgen is studying it in healthy participants and in people with mild-to-moderate asthma.
AMG 691 is being studied for the treatment of asthma. The only clinical trial of AMG 691 to date enrolls adults with mild-to-moderate asthma as well as healthy participants. Because the drug remains in Phase 1 testing, it is investigational and is not approved for treating asthma or any other condition.
AMG 691 is developed by Amgen Inc., the biotechnology company that trades on Nasdaq under the ticker AMGN. Amgen is running the Phase 1 program for the drug in asthma, including a study conducted across the United States, Australia, Belgium, Canada, and the United Kingdom.
AMG 691 is in Phase 1 clinical development. It has one active trial, which is currently not recruiting, and no completed trials. The study is a randomized, double-blind, placebo-controlled Phase 1 trial, and the drug has not been approved by the FDA or any other regulator.
AMG 691 is being evaluated in the Phase 1 trial NCT06637371, titled A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma. The trial has an enrollment of 21 participants, is active but not recruiting, and is conducted in the United States, Australia, Belgium, Canada, and the United Kingdom.
Yes, the AMG 691 Phase 1 trial in asthma is biomarker selected, meaning participants are enrolled based on a specified biomarker rather than an unselected asthma population. The study is randomized, double-blind, and placebo-controlled, and it includes both healthy volunteers and adults aged 18 years and older with mild-to-moderate asthma.