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Pila Pharma was founded by Dorte X. Gram after she discovered that TRPV1 antagonists can be used for treatment of diabetes and obesity. These surprising discoveries were made at the turn of the millennium when Dorte X. Gram during her PhD studies, and as part of her work as a researcher at Novo Nordisk A/S, investigated the effects of capsaicin receptor modulator (TRPV1) in animal models. Two decades later, several important milestones have been reached.

Important milestones

Year Milestone
1999 Dorte X. Gram discovers that TRPV1 can regulate blood sugar in diabetic rats through improved insulin secretion
1999-2005 The Gram-hypothesis is formulated and preclinical studies support the hypothesis
2005 Dorte X. Gram files use patents on the treatment of diabetes and obesity with TRPV1 antagonists for Novo Nordisk
2008 For strategic reasons, Novo Nordisk shuts down or sells all projects and patents regarding small molecules

The rights/use patent application on the discovery for treatment of diabetes and obesity with TRPV1 antagonists are acquired by Gram through her company XENIA PHARMA, Denmark, from Novo Nordisk, Denmark

2011 For strategic reasons, Bayer closes all urogenital projects and patents, and sells its TRPV1 assets to Ario Pharma

Use patent in the US issued to XENIA PHARMA for treatment of obesity with TRPV1 antagonists

2013 Use patent in the US and Europe issued to XENIA PHARMA for treatment of type 1 and 2 diabetes, insulin resistance and impaired glucose tolerance with TRPV1 antagonists
2014 Pila Pharma founded in Sweden as a fully owned subsidiary to XENIA PHARMA, Denmark

Use patents are transferred to the Company

2015 Almi Invest invests and finances preclinical screenings of selected clinical development candidates
2016 TRPV1 antagonist assets including XEN-D0501 licensed from Ario Pharma, UK (indirectly Bayer, Germany)
2017 Permission to try single ascending dose for patients with type 2 diabetes with XEN-D0501 (clinical study PP-CT01)
2018 The concession agreement regarding Ario Pharma TRPV1 renegotiated

The clinical study PP-CT01 shows a good safety profile of XEN-D0501 after patients with type-2 diabetes are treated with single doses

Permission to treat patients with type 2 diabetes with XEN-D0501 for 28 days (clinical study PP-CT02)

2019 The clinical study PP-CT02 is conducted
2020 Licensing agreement regarding royalties for XEN-D0501 to Ario Pharma ceases

The clinical study PP-CT02 shows a good safety profile and effect of XEN-D0501 on insulin secretion after 28 days of treatment of patients with type-2 diabetes

The company’s Board decides on a listing on the stock exchange and Göteborg Corporate Finance is hired as a financial advisor

2021 During the first quarter, the Company carries out a new share issue, which is oversubscribed The Company receives MSEK 14.1, after issue costs (before listing)

The Company is registered as a public company

The Company implements a 10:1 split, with the condition that each share held yields ten new shares

During the second quarter, the Company carries out a new share issue in connection with listing on the Nasdaq First North Growth Market in Stockholm, and the Company receives MSEK 31.5, after issue costs

Several important agreements are signed with partners, including the British Quay Pharma for manufacture of new tablets, the British Almac for manufacture of API, and the French ERBC for implementation of a three-month preclinical study

2022 Production of study drug (XEN-D0501 API) was completed with very good results and certificate of analysis obtained

An agreement was signed with British Quay Pharma on the development of a suitable formulation of XEN-D0501 API for use in the upcoming preclinical studies in diabetes type-2

An agreement was signed with British LGC Drug Development Solutions on the establishment of an analytical method to measure XEN-D0501 in samples from the preclinical studies

The company held an annual general meeting on June 7, 2022, whereby the board was authorized to, in the time until the next annual general meeting, decide on a new issue of shares, warrants and/or convertibles. At the annual general meeting, Milan Zdravkovic was elected as a board member

In July 2022, Pila Pharma was granted Orphan Drug Designation in the USA for XEN-D0501 for the treatment of the rare disease erythromelalgia

Dr. Hans Quiding was hired as project manager for work on new projects, including the erythroemalgia project

Pila Pharma, in collaboration with ERBC, France, in the period June 2022 to March 2023 conducted a 13-week preclinical safety studies with the development candidate XEN-D0501 in two animal species without registration of side effects, which enables XEN-D0501 to be included in clinical studies of up to 3 months duration

During quarter 4, the company carried out a rights issue and the company received SEK 6.9 million after issue costs

European Journal of Neuroscience, Volume 25, Issue 1, pages 213–223, January 2007

In 1999, Dorte X. Gram’s first experimental study in diabetic rats most surprisingly revealed a very dramatic effect on the control of hyperglycemia following the systemic administration of capsaicin (sensory desensitization). This led to a change of focus during the PhD studies to exploring the role of sensory nerves in experiemental diabetes.

Use Patent Application

Download as PDF:
use-patent application

Download patents as PDF:
US7879866B2 / US8455504B2EP1771162B1

Read the:
General EU announcement as PDF 
The project abstract as PDF here

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