About us

about us

The Next Generation of Soft Mist Inhalators

Softhale is developing pharmaceutical inhalation products for major respiratory markets in the USA, Europe, and Asia.

Based in Diepenbeek, Belgium, Softhale N.V. is a pharmaceutical company specializing in the development of inhalable respiratory products for the medical treatment of various indications including, for example, Asthma or COPD. In Softhale’s office and labs, the focus lies on product development, formulation development, and analytical capabilities. The team is led by international industry experts (hardware, formulation, analytics, manufacturing, commercialization) and supported by external (inter-)national services providers.

We are extending our in-house capabilities and competences to prepare the company to be able to become a production company in addition to a product development company.

Development Focus

The rise in the number of chronic obstructive pulmonary disease patients (COPD), TB, asthma, pneumonia, and other diseases of the respiratory tract and lung remains the major driver of the industry. Chronic respiratory diseases affect the entire airway system and other parts of the lungs. Respiratory symptoms are among the major causes of consultation with doctors and physicians in primary health care centers. There is an increasing need of innovative, and at the same time affordable, inhalable medications.

Therefore, high-quality but more affordable alternative treatment options to already established inhalation products are the initial and most advanced targets.

In addition, we plan to use the inhaler platform technology for innovative inhalation products either by combining approved drugs with the Soft Mist Inhaler and/ or by delivering New Chemical Entities (NCE). The latter ones are development activities with partner companies.


Softhale performs much of the feasibility assessment work, early formulation, analytics and device development, and performance evaluation internally. Softhale also has a core respiratory product development team that is leading a network of international partners to perform the full/ late-stage development work for regulatory submission. Development activities for projects according to FDA 505(j) and 505(b)(2) abbreviated approval pathways are ongoing. Additional projects are also under assessment.

Meet our Team of Experts

As a group, our Board offers profound medical, pharmaceutical/chemical, medical device, and consumer product expertise. It consists of members of the Series A & B multi-national venture capital consortium, the CEO, a non-executive director, a founder’s representative, and the chairman.

Meet our Team