Science with a different perspectiveA Danish biopharmaceutical company ↗

Our products

Established medicines. New possibilities.

AFYX develops and commercializes specialty pharmaceutical products, with a focus on reformulation, repurposing and unmet medical needs.

Women’s health · Regulatory milestone

EU approval for low-dose oral misoprostol.

In May 2026, AFYX Therapeutics received approval for its low-dose oral misoprostol tablet for induction of labour in 20 European countries and Northern Ireland.

The approval is an important regulatory milestone and reflects AFYX’s continued focus on women’s health and medicines developed for use within established clinical care settings.

The proprietary 25 microgram oral tablet is a ready-to-use low-dose formulation intended to avoid manual tablet fractioning or pharmacy compounding. Misoprostol is recommended by the World Health Organization as a first-line option for labour induction, with extensive clinical experience supporting its use.

AFYX has described an estimated 1.2 million labour inductions annually in the EU and plans a stepwise commercial roll-out with local and regional partners, subject to national pricing and reimbursement. The company has also described preparation for regulatory submissions beyond Europe.

AFYX is preparing next steps required to make the product available in approved markets, working with relevant partners and authorities as applicable.

Important information: Induction of labour is a medical procedure that should only be performed when clinically indicated and under the supervision of qualified healthcare professionals, in accordance with local clinical protocols and approved product information. Healthcare professionals should refer to the locally approved Summary of Product Characteristics and local guidance.

Read the approval announcement
AFYX product packagingAFYX product presentation

Areas of development

Our portfolio at a glance.

Head & neck cancer

Nimorazole (Nimox) is a hypoxic radiosensitizer used alongside radiotherapy. AFYX also develops proprietary patch technologies for cancer and mucosal conditions.

Cluster headache

AFYX holds a U.S. patent for intranasal ketamine treatment of cluster headache. The company has described a Phase 2B study planned for 2027.

Women’s health

Gefena is AFYX’s low-dose 25 microgram oral misoprostol tablet for induction of labour, approved in 20 European countries and Northern Ireland in May 2026.

Pain & addiction

AFYX’s public pipeline includes diamorphine and buprenorphine programs, alongside established specialty medicines including Diaphine.

Oral and mucosal disease

The June 2026 pipeline includes clobetasol patch programs for oral lichen planus, vulvar lichen sclerosus and recurrent aphthous stomatitis.

Additional patch programs

The public pipeline also lists AFYX patch programs for oral premalignant lesions and head and neck cancer.

Named programs · June 2026

ProgramAsset / technologyIndication shown in the public pipeline
AFYX-001NimorazoleHead & neck cancer
AFYX-002Diamorphine & buprenorphineAddiction
AFYX-003MisoprostolLabour induction
AFYX-004Intranasal esketamineCluster headache
AFYX-005Clobetasol patchOLP, VLS and RAS
AFYX-006/007Patch with chemotherapyOral premalignant lesions / head & neck cancer

Historical product names in AFYX materials include Gefena, Nimox and Diaphine. Development programs and product availability vary by country. For the source pipeline graphic, see AFYX’s pipeline.

AFYX laboratory research

From research to care

Built on proven science.

AFYX seeks to create new opportunities by combining established medicines, innovative formulations and focused clinical development.

Read the latest company updates

Patient safety

Experiencing a side effect? Let us know.

Patients, carers and healthcare professionals can report a suspected side effect to AFYX Pharmacovigilance. Please report suspected effects even if you are unsure they were caused by a medicine.

Open the side-effect report form

Share only information needed for AFYX’s safety team to assess your report. On submission, your email app opens with the form details for you to review; this website does not store or send the report automatically. Email is not suitable for urgent medical concerns. Contact a healthcare professional or emergency services if you need urgent help.

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