ALV-200
Low EvidenceALV-200 is Alveus Therapeutics' highly selective amylin receptor 3 (AMYR3) peptide agonist in IND-enabling development for obesity, designed to capture amylin's weight-loss and lean-mass-preserving benefits while avoiding the nausea and aversion tied to calcitonin-receptor activation. It is engineered for once-weekly dosing.
What It Is
ALV-200 is a next-generation amylin analog built around a receptor-selectivity thesis. Amylin, a pancreatic hormone co-secreted with insulin, drives satiety and slows gastric emptying and is one of obesity medicine's most clinically validated pathways beyond GLP-1. But amylin signals through several receptors: the calcitonin receptor (CTR) and the amylin receptors AMYR1, AMYR2 and AMYR3 (each formed by the calcitonin receptor paired with a receptor-activity-modifying protein, RAMP1/2/3). Most amylin analogs now in the clinic - including cagrilintide, petrelintide and older agents - are dual amylin-calcitonin receptor agonists (DACRAs) that activate CTR as well as the amylin receptors. Alveus's hypothesis, reflected in ALV-200's design, is that amylin's desirable metabolic effects (appetite suppression, weight loss and, notably, preservation of lean mass) are driven largely through AMYR3, whereas the gastrointestinal liabilities of amylin agonism - nausea, vomiting and food aversion - are driven mainly by CTR activation. By selectively agonizing AMYR3 with significant selectivity over CTR, ALV-200 aims to keep the weight-loss efficacy while improving tolerability. In Alveus's preclinical models the molecule maintained weight-loss efficacy while showing meaningful CTR selectivity, and it is engineered for once-weekly subcutaneous dosing. ALV-200 is the injectable centerpiece of Alveus's amylin franchise, which also includes oral small molecules and multifunctional formats. Alveus Therapeutics - a Philadelphia- and Copenhagen-based obesity company that launched from stealth on January 8, 2026 with a $159.8 million Series A (upsized to roughly $197 million in a February 2026 final close) - has said it plans to bring ALV-200 into first-in-human clinical studies within roughly 18 months of launch. The company's lead clinical program is ALV-100, a bifunctional GIPR-antagonist / GLP-1R-agonist fusion protein. ALV-200 reflects the broader 2026 'amylin renaissance,' in which receptor-selective and lean-mass-sparing mechanisms are being pursued as the next pillar of obesity medicine alongside GLP-1-based drugs.
Regulatory Status
In IND-enabling (preclinical) development; no IND cleared and no human trials begun as of mid-2026. Alveus has stated plans to start first-in-human studies within roughly 18 months of its January 2026 launch. Not approved in any jurisdiction.
Effective: 2026
View FDA SourceWhy Researchers Study It
ALV-200 tests a specific, mechanistically appealing idea: that separating amylin's benefits from its side effects is possible at the receptor level. If the beneficial metabolic effects of amylin - especially lean-mass preservation - really are AMYR3-driven while the nausea and aversion are CTR-driven, then an AMYR3-selective agonist could deliver amylin's weight-loss efficacy with markedly better gastrointestinal tolerability than the dual amylin-calcitonin receptor agonists (DACRAs) that dominate the current amylin pipeline. Researchers also study it because amylin is one of the most validated non-GLP-1 obesity pathways, because lean-mass-sparing weight loss is a central goal of next-generation obesity drugs, and because the asset is well financed and backed by a leadership team drawn from Novo Nordisk and Eli Lilly metabolic programs.
Proposed Mechanisms
- Selectively agonizes amylin receptor 3 (AMYR3) - the calcitonin receptor paired with RAMP3 - to drive satiety and weight loss
- Shows significant selectivity over the calcitonin receptor (CTR), the receptor implicated in amylin-related nausea and food aversion
- Aims to preserve lean mass during weight loss, an effect attributed largely to AMYR3 signaling
- Engineered for once-weekly subcutaneous dosing to reduce treatment burden
- Positioned as a more receptor-selective alternative to dual amylin-calcitonin receptor agonists (DACRAs)
Evidence Snapshot
| Study Type | Model | Outcome | Link |
|---|---|---|---|
| Preclinical | Alveus obesity/metabolic preclinical models | ALV-200 maintained weight-loss efficacy while showing significant selectivity for AMYR3 over the calcitonin receptor (CTR); suitable for once-weekly dosing | Source |
| Company / financing | Alveus Therapeutics Series A financing | Launched Jan 8, 2026 with $159.8M Series A (upsized to ~$197M in Feb 2026); proceeds support IND filing of ALV-200 and its amylin pipeline, with first-in-human studies planned within ~18 months | Source |
Commonly Discussed Benefits
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Safety & Cautions
- Preclinical / IND-enabling only - no human safety or efficacy data yet
- The AMYR3-vs-CTR selectivity hypothesis (benefits from AMYR3, side effects from CTR) is not yet confirmed in humans
- Human weight-loss magnitude, lean-mass benefit and tolerability advantage are unproven
- Long-term safety and efficacy unknown
- Not available outside eventual clinical trials; not FDA-approved and not a compounding-eligible peptide
- Any 'ALV-200' offered by a vendor is unverified - it is a proprietary investigational candidate
Comparisons
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Citations
- [1] Alveus Therapeutics - Science (ALV-200 AMYR3-selective amylin agonist) PubMed
- [2] Alveus Therapeutics Launches with $160 Million Series A Financing (Jan 8, 2026) PubMed
- [3] Alveus Therapeutics Announces Second and Final Closing of Oversubscribed Series A (~$197M total) PubMed
- [4] Fierce Biotech - Equipped with $160M Series A, Alveus debuts into crowded obesity landscape PubMed
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Eloralintide
Medium EvidenceA selective, long-acting amylin receptor agonist in Phase 3 trials for obesity, offering a GLP-1-independent weight loss mechanism with up to 20.1% weight loss in Phase 2.
Amycretin
Medium EvidenceA unimolecular GLP-1 and amylin receptor dual agonist in Phase 3 trials, available in both subcutaneous and oral formulations, with up to 22% weight loss in Phase 1b/2a.
ALV-100
Low EvidenceA bifunctional GIPR-antagonist / GLP-1 receptor-agonist peptide in early clinical development for obesity, designed to improve the quality and durability of weight loss and long-term weight maintenance.
Petrelintide
Medium EvidenceA long-acting amylin analog in late-stage clinical development for chronic weight management, designed to deliver double-digit weight loss with a tolerability profile comparable to placebo.
ASC39
Low EvidenceASC39 is Ascletis Pharma's investigational once-daily oral small-molecule amylin-selective amylin receptor agonist for obesity. In head-to-head preclinical assays it matched Eli Lilly's injectable peptide eloralintide on amylin-receptor potency, selectivity over the calcitonin receptor, and weight loss in diet-induced obese rats. Ascletis plans to file a U.S. FDA IND for ASC39 - and for a fixed-dose combination with its oral GLP-1 agonist ASC30 - in the third quarter of 2026.
MET-233i
Medium EvidenceMET-233i is a first-in-class, once-monthly ultra-long-acting amylin analog for obesity, originally developed by Metsera and now a Pfizer asset. In its Phase 1 trial it produced up to 8.4% placebo-subtracted weight loss after five weekly doses and showed a roughly 19-day half-life - the most durable of any reported amylin analog - supporting once-monthly subcutaneous dosing. It is engineered to be combined with Metsera's monthly GLP-1 agonist MET-097i in a single once-monthly injection.