MAM-1004-1/Budesolv is a nasal spray containing the corticosteroid budesonide solubilized with Marinomeds proprietary Marinosolv solubilization technology. Budesolv is intended to treat severe allergic rhinitis and has met all endpoints in a phase III clinical trial. Due to the solubilized, readily available form, a therapeutic effect could be achieved with a significantly lower dose (85% lower than comparable marketed products). Furthermore, the increased bioavailability allows a significantly faster onset of action: Budesolv led to a noticeable reduction in allergic nasal symptoms and a significant reduction in asthmatic symptoms in less than three hours after the first dose. The unique Marinosolv-formulation offers further advantages: due to the dissolved form of the active ingredient, shaking is not necessary and the risk of misdosing is greatly reduced. The formulation is free of potentially irritating preservatives and well tolerated. Furthermore, the reduction of the amount of active pharmaceutical ingredient contributes to sustainability, as less drug substance pollutes the environment, particularly the wastewater.
MAM-1004-1/Budesolv
Short facts
Active pharmaceutical ingredient | Budesonide (corticosteroid) |
Indication | Allergic rhinitis |
Development phase | Filing in preparation |
Classification | Pharmaceutical product |
Available for partnering! If you are interested, please visit our BD website or contact bd@marinomed.com.

Allergic rhinitis (AR) is one manifestation of a type I hypersensitivity reaction caused by an immune reaction to otherwise innocuous agents such as pollen or house dust mites. The disease can occur both perennially (e.g. house dust mite allergy) or seasonally (e.g. grass pollen allergy). In the past decades, a globally rising trend of AR has been observed with widely varying prevalence, particularly in the developing countries. Up to 30% of the global population may be affected. While allergic rhinitis refers to an inflammatory process of the nasal passages, symptoms involve the nose and may extend beyond to affect the eyes, ears, sinuses and bronchi. Commonly reported nasal symptoms include nasal itching and congestion, runny nose and sneezing. Often, AR will involve the conjunctivae; such patients may experience itching, tearing and red eyes. About 40% of AR patients also suffer from asthmatic symptoms like cough, wheeze and dyspnea. In fact, AR is considered an independent risk factor for subsequent asthma. Some studies have shown that treatment for AR can reduce healthcare costs and lead to a better asthma control.
Apart from allergen avoidance and physical measures, current therapy of AR comprises two main treatment options: Pharmaceuticals targeting the effects of messenger substances secreted by mast cells or hypersensitization to specific allergens. Anti-allergic pharmaceuticals can be divided into three categories: Antihistamines prevent histamine from binding to its receptor, mast cell stabilizers (e.g. cromoglycate) are supposed to reduce the secretion of messengers, and glucocorticoids inhibit the production and release of proinflammatory substances such as TNF-alpha.
Poor solubility and associated poor bioavailability result in delayed onset of action, especially when applied locally in the nose. The suspension with undissolved particles used must be applied for a number of days before an effect occurs.
- Faster onset of action
- Reduced dose
- Preservative-free
- Suitable for sensitive tissues such as the nasal mucosa
- No shaking necessary
- Decreased risk of misdosing
MAM-1003-1/Tacrosolv
Short facts
Active pharmaceutical ingredient | Tacrolimus (immunosuppressant) |
Indication | Severe inflammatory ocular surface diseases |
Development phase | Phase II clinical study |
Classification | Pharmaceutical product |
Available for partnering! If you are interested, please visit our BD website or contact bd@marinomed.com.

MAM-1003-1/Tacrosolv is a topically applied, anti-inflammatory and immunomodulating ophthalmic solution, containing Tacrolimus solubilized with Marinomeds proprietary Marinosolv solubilization technology. Tacrolimus is a well-known calcineurin inhibitor and highly potent immunosuppressant used in organ transplantation as well as inflammatory eye and skin conditions. However, Tacrolimus is a highly lipophilic substance with very low water solubility. Based on the proprietary Marinosolv technology, Marinomed has developed a novel aqueous formulation, which allows the complete solubilization of the compound using known excipients. Thus, Marinosolv is able to unfold the full potential of Tacrolimus even at very low concentrations.
It could be demonstrated that the topical application of Tacrosolv results in higher concentrations of Tacrolimus in ocular tissue compared to Talymus (Tacrolimus in suspension), a product marketed in Asia to treat vernal keratoconjunctivitis. Even though the concentration of the drug was reduced up to 95%, sufficient concentrations of the drug were detected in different tissues of the eyes, such as conjunctiva and cornea. An exploratory phase II clinical trial for dose finding was performed in the model indication of allergic rhinoconjunctivitis. The higher dose group demonstrated a significant relief of allergic symptoms in the eyes and also in the nose already after eight days of treatment.
Based on its anti-inflammatory and immunomodulatory effect, Tacrosolv offers great potential as treatment in different ocular surface diseases, such as dry eye disease, ocular graft versus host disease, severe refractive conjunctivitis, vernal/atopic keratoconjunctivits or herpetic stromal keratitis.
Management of anterior segment inflammatory eye diseases often involve the long-term use of topical and/or systemic corticosteroids, which can lead to raised intraocular pressure and associated complications such as cataract and glaucoma. Alternative treatment options include the use of immunosuppressive compound cyclosporin, which has a comparable safety profile to Tacrolimus but is ~100 times less potent.
- Faster onset of action
- Reduced dose
- Suitable for sensitive tissues such as eyes
- Suitable for a wide range of ocular diseases