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AGN-151586
AGN-151586 is a Selective Androgen Receptor Modulator (SARM) Small molecule drug developed by AbbVie. It is currently in Phase 3 development for Muscle wasting / sarcopenia, Hypogonadism (potential indication).
AGN-151586 is a selective androgen receptor modulator (SARM) that activates androgen signaling in a tissue-selective manner.
AGN-151586 is a small molecule being studied as a potential treatment for glabellar lines, with a phase 3 clinical trial (NCT05248867) comparing its efficacy to BOTOX and a placebo. The trial is assessing the safety and change in disease activity of intramuscular AGN-151586 injection in adult participants with glabellar lines.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
AbbVie is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | AGN-151586 |
|---|---|
| Sponsor | AbbVie |
| Drug class | Selective Androgen Receptor Modulator (SARM) |
| Target | Androgen Receptor (AR) |
| Modality | Small molecule |
| Therapeutic area | Endocrinology / Musculoskeletal |
| Phase | Phase 3 |
Mechanism of action
SARMs bind to the androgen receptor and promote anabolic effects in muscle and bone while minimizing androgenic side effects in other tissues. AGN-151586 is designed to provide the benefits of androgen therapy with improved selectivity and safety profile compared to traditional androgens.
Approved indications
- Muscle wasting / sarcopenia
- Hypogonadism (potential indication)
Common side effects
- Testosterone suppression
- Liver enzyme elevation
- Lipid profile changes
Key clinical trials
- A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Toxin-Naïve Adult Participants With Glabellar Lines (PHASE3)
- A Study to Assess the Adverse Events of Intramuscular Injections of AGN-151586 and OnabotulinumtoxinA in Adult Participants for the Change of Glabellar Lines (GL) (PHASE1)
- A Study to Evaluate AGN-151586 Intramuscular Injections in Adult Participants for Treatment of Glabellar Lines (PHASE3)
- A Study to Assess Adverse Events of Intramuscular AGN-151586 Injection in Adult Participants With Glabellar Lines (PHASE3)
- A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Adult Participants With Glabellar Lines (PHASE3)
- Study of AGN-151586 in Japanese Participants With Moderate to Severe Glabellar Lines (PHASE1)
- AGN-151586 Dose-Ranging Study for Treatment of Glabellar Lines (PHASE2)
- A Study to Evaluate Sequential Administration of AGN-151586 and OnabotulinumtoxinA (BOTOX) Injections in Adult Participants for Treatment of Glabellar Lines (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- AGN-151586 CI brief — competitive landscape report
- AGN-151586 updates RSS · CI watch RSS
- AbbVie portfolio CI
Frequently asked questions about AGN-151586
What is AGN-151586?
How does AGN-151586 work?
What is AGN-151586 used for?
Who makes AGN-151586?
What drug class is AGN-151586 in?
What development phase is AGN-151586 in?
What are the side effects of AGN-151586?
What does AGN-151586 target?
Related
- Drug class: All Selective Androgen Receptor Modulator (SARM) drugs
- Target: All drugs targeting Androgen Receptor (AR)
- Manufacturer: AbbVie — full pipeline
- Therapeutic area: All drugs in Endocrinology / Musculoskeletal
- Indication: Drugs for Muscle wasting / sarcopenia
- Indication: Drugs for Hypogonadism (potential indication)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing