Strong patent protection beyond 2040

Follicum has a strong foundation of patents providing solid market protection until 2040. There are two key patents: firstly, the composition of matter of FOL005 and its use to stimulate hair growth (WO2013021212) which is granted in all major markets and secondly, the unique topical formulation of FOL005 enabling the peptide to penetrate the skin (PCT/EP2020/061453).

In addition, a priority application has been submitted for the use of FOL005 in wound healing in May 2022. All patents are submitted in major markets including the US, Europe, Canada, Australia, Japan, China and India.

Next steps – costs, partnering and out-licensing

Roadmap until 2025

The primary objective of Follicum will be to develop FOL005 for the treatment of hair loss and secondarily to develop FOL005 for the treatment of diabetic wounds. The planning of clinical trials is ongoing and depending on design of these studies and appropriate funding, we currently predict the following key milestones until the end of 2025:

Hair loss (andro-genetic alopecia) – preliminary milestones 
2H 2023: Finalization of pre-clinical 9 months tolerability testing
2H 2023: Key partners identified for funding and development of FOL005
1H 2024: First patient in phase IIb study (FCS-004) in hair loss.
2H 2025: Key results of phase IIb FCS-004
2H 2025: Scientific Advice meetings to prepare phase III pivotal program

Wound healing – preliminary milestones
1H 2024: First patient in phase II study (FCS-004) in hair loss.
1H 2025: Key results of phase II FCS-004

Clinical cost

The goal is to identify a license or co-development partner for financing the clinical trials with FOL005 in hair loss and in wound healing. Depending on the number of study patients and length of study, we estimate the following clinical cost:

Total cost for the pre-clinical tolerability studies: 6-9 mSEK.

Phase IIb clinical trial – hair loss
Total cost of implementation and completion of the phase IIb study: 50-70 mSEK.

Phase IIa clinical trial wound healing
Total cost of implementation and completion of phase IIa study: 20-25 mSEK

Exit strategy

We believe there is a high likelihood of success based on the previous clinical data. The next phase IIb will strongly increase the value of FOL005 and our strategy is to identify a license or co-development partner to share the risk of further development. Our goal is to make a license co-development agreement before initiating the phase IIb clinical trial in hair loss.


FOL005 is among the very few assets in late stage development for hair loss and truly represents a novel mode of action. Ignoring the companies developing reformulations of existing marketed products, the late stage pipeline is dominated by companies developing topical androgen receptor antagonists. Kintor Pharmaceutical has advanced furthest and is in phase III with KX-826 in China for the treatment of male hair loss. Breezula from Cosmo Pharma has not progressed since reporting phase IIb data in 2019. (, GlobalData)