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AGN-199201
AGN-199201 is a Selective androgen receptor modulator (SARM) Small molecule drug developed by Allergan. It is currently in Phase 3 development for Muscle wasting and weakness in aging males, Osteoporosis or bone loss.
AGN-199201 is a selective androgen receptor modulator (SARM) that activates androgen signaling in target tissues.
AGN-199201 is a selective androgen receptor modulator (SARM) that activates androgen signaling in target tissues. Used for Muscle wasting and weakness in aging males, Osteoporosis or bone loss.
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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).
| 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-199201 |
|---|---|
| Sponsor | Allergan |
| 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 like AGN-199201 bind to androgen receptors with tissue selectivity, promoting anabolic effects in muscle and bone while minimizing androgenic side effects seen with traditional androgens. This selective activation aims to provide therapeutic benefits for conditions requiring androgen activity without the full systemic effects of conventional hormone replacement.
Approved indications
- Muscle wasting and weakness in aging males
- Osteoporosis or bone loss
Common side effects
- Testosterone suppression
- Liver enzyme elevation
- Headache
Key clinical trials
- A Study of the Concurrent Use of AGN-190584 and AGN-199201 in Participants With Presbyopia (PHASE2)
- A Safety, Efficacy and Pharmacokinetic Study of AGN-199201 and AGN-190584 in Patients With Presbyopia (PHASE2)
- Safety and Efficacy of Oxymetazoline HCl Cream 1.0% in Patients With Persistent Erythema Associated With Rosacea (PHASE3)
- Efficacy and Safety of AGN-199201 in Patients With Persistent Erythema Associated With Rosacea (PHASE3)
- A Long-Term Safety and Efficacy Study AGN-19920 in Patients With Persistent Erythema Associated With Rosacea (PHASE3)
- Safety and Tolerability of AGN-199201 in Patients With Erythema Associated With Rosacea (PHASE1)
- AGN-199201 for the Treatment of Erythema With Rosacea (PHASE2)
- Safety and Efficacy of AGN-199201 and AGN-190584 in Patients With Presbyopia (PHASE2)
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-199201 CI brief — competitive landscape report
- AGN-199201 updates RSS · CI watch RSS
- Allergan portfolio CI
Frequently asked questions about AGN-199201
What is AGN-199201?
How does AGN-199201 work?
What is AGN-199201 used for?
Who makes AGN-199201?
What drug class is AGN-199201 in?
What development phase is AGN-199201 in?
What are the side effects of AGN-199201?
What does AGN-199201 target?
Related
- Drug class: All Selective androgen receptor modulator (SARM) drugs
- Target: All drugs targeting Androgen receptor (AR)
- Manufacturer: Allergan — full pipeline
- Therapeutic area: All drugs in Endocrinology / Musculoskeletal
- Indication: Drugs for Muscle wasting and weakness in aging males
- Indication: Drugs for Osteoporosis or bone loss
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing