Vamorolone is a synthetic corticosteroid and pharmaceutical active pharmaceutical ingredient (API) belonging to the glucocorticoid class. It is a structurally modified steroid developed for its glucocorticoid receptor activity and is used in pharmaceutical applications associated with Duchenne muscular dystrophy (DMD).
Vamorolone is identified by CAS No. 13209-41-1, molecular formula C22H28O4, and molecular weight approximately 356.46 g/mol. FDA substance records identify Vamorolone by UNII 8XP29XMB43, while PubChem lists CAS 13209-41-1 and molecular weight 356.5 g/mol.
Vamorolone is a fully synthetic corticosteroid structurally related to glucocorticoid steroids. It is also known by names including VBP-15, VBP-15 free alcohol, and 17,21-dihydroxy-16α-methylpregna-1,4,9(11)-triene-3,20-dione.
Principal product characteristics include:
FDA's substance record confirms the chemical identity and formula, while the FDA AGAMREE label describes Vamorolone as a corticosteroid.
Vamorolone is used in the treatment of Duchenne muscular dystrophy in appropriate patients. FDA approved AGAMREE (vamorolone) on October 26, 2023 for treatment of DMD in patients 2 years of age and older.
The drug acts as a corticosteroid and glucocorticoid receptor agonist. PubChem identifies its FDA pharmacological class as a corticosteroid and its mechanism as a corticosteroid hormone receptor agonist.
FDA describes Vamorolone as a white to off-white powder. It is reported to be freely soluble in methanol and dioxane and sparingly soluble in ethanol and acetone.
Published technical information also reports limited aqueous solubility. One pharmaceutical development source reports thermodynamic aqueous solubility of approximately 33–37 µg/mL at 37°C across pH 1–7, while another FDA review reports approximately 0.07 mg/mL in FeSSIF. These are formulation/development measurements rather than a universal API release specification.
Several crystalline forms of Vamorolone have been described in patent literature. One published patent specifically describes Vamorolone Form I and characterizes it using solid-state analytical techniques.
For Form I, the patent reports a DSC melting event with an onset around 231.0°C and a peak around 234.7°C. The same patent describes Form I as having chemical purity of at least about 95%, including embodiments of at least 99% and 99.5% HPLC purity. These values are patent-described technical characteristics, not a universal pharmacopeial release specification.
Therefore, a general Vamorolone product page should not claim a particular polymorph unless the supplied API has been specifically characterized.
Public technical literature demonstrates HPLC methods for Vamorolone and describes chemical-purity controls. A recent synthesis publication reports Vamorolone material at >99% area/area by LC/MS and, following recrystallization, approximately >99% area/area and 99% w/w. These are process-specific results rather than an official universal specification.
For commercial API release, assay, related substances, residual solvents, water, residue on ignition and other quality attributes should be controlled according to the manufacturer's approved specification and applicable regulatory requirements.
Swapnroop Drugs & Pharmaceuticals supports pharmaceutical customers requiring Vamorolone API for pharmaceutical development and manufacturing applications.
As a Vamorolone API manufacturer and supplier in India, the product can be positioned for pharmaceutical customers requiring a synthetic corticosteroid API with controlled identity, purity, impurity profile and appropriate solid-state characterization.
Typical pharmaceutical documentation may include:
Vamorolone API should be stored in suitable pharmaceutical packaging under controlled environmental conditions according to the approved product specification and stability data.
The applicable storage conditions should be established from the API stability program rather than inferred solely from the finished pharmaceutical product.
Vamorolone is a synthetic glucocorticoid API with CAS 13209-41-1, molecular formula C22H28O4, and molecular weight 356.46 g/mol. It is a non-salt small-molecule corticosteroid and is associated with pharmaceutical applications for Duchenne muscular dystrophy.
Crystalline forms of Vamorolone have been described in patent literature. Because polymorphic form can affect solid-state characteristics, a product marketed simply as Vamorolone should not be assigned a particular crystalline form unless the material has been confirmed by an appropriate analytical method such as PXRD.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 97.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Individual Impurity | NMT 0.5% |
| Melting Point | Approx. 231–235°C |