Back to Stakeholders
Research, Drug Development & Manufacturing
Research, Drug Development & ManufacturingCompany-Led Drug Development & CommercializationClinical Research & Pipeline Products
Research, Drug Development & ManufacturingCompany-Led Drug Development & Commercialization
Lead program: Phase I

Lophora

Also known as: Lophora ApS

2 Drug Candidates

Lophora ApS is a Danish biotech developing next-generation selective 5-HT2A receptor agonists for psychiatric disorders. Their lead compound LPH-5, a novel cyclized phenethylamine, is in Phase 1 trials at Biotrial in Rennes, France. LPH-5 shows exceptional 5-HT2A selectivity and can produce antidepressant effects at sub-psychedelic doses. Secondary candidate LPH-48 is being explored for alcohol use disorder.

Development Programmes

2

LPH-5

Phase I
Treatment-Resistant Depression (TRD)Major Depressive Disorder (MDD)

Treatment-resistant depression

Programme Tracker

Treatment-Resistant Depression (TRD)

Primary: EU (EMA)
Phase IActive

Phase I SAD/MAD trial in healthy volunteers active at Biotrial, Rennes, France; first subjects dosed May 2025; expected completion Q4 2025

Milestones

Phase I started

Completed

Actual: May 1, 2025

First subjects dosed in Phase I SAD/MAD trial (EudraCT 2023-000463-32); trial site: Biotrial, Rennes, France

Why it matters: LPH-5 is the first 5-HT2A agonist NCE from a Scandinavian spinout to enter human trials. The EU CTA plus ANSM (French) approval validates LPH-5's preclinical safety package. SAD/MAD design in healthy volunteers will establish dose range and PK/PD for patient trials.

Watch next: Phase I topline safety and PK/PD data expected Q4 2025; IND filing for US Phase II

Funding milestone

Completed

Actual: Jan 1, 2025

$3M financing closed (BioInnovation Institute, Innovation Fund Denmark, EIFO)

Why it matters: LPH-5 is a next-generation 5-HT2A agonist NCE engineered for selectivity — a novel psychedelic-inspired compound with composition-of-matter patents in US, EU, China, Japan. The $3M financing enables Phase I completion. BII is a Novo Nordisk Foundation subsidiary, adding credibility to the programme.

Recorded Events

May 1, 2025: Phase I started

Jan 1, 2025: Funding milestone

LPH-48

Pre-clinical
Major Depressive Disorder (MDD)

CNS / neuropsychiatric disorders

Programme Tracker

Major Depressive Disorder (MDD)

Primary: EU (EMA)
Pre-clinicalActive

Preclinical development of fast-follower 5-HT2A agonist NCE with optimised receptor selectivity profile vs. LPH-5

Milestones

Pre-clinical started

ongoing

Why it matters: LPH-48 is a second NCE in Lophora's proprietary 5-HT2A agonist series, designed with an optimised profile relative to LPH-5. A two-asset pipeline reduces single-compound risk and provides backup if LPH-5 hits unexpected safety or PK issues in Phase I.

Watch next: Lead compound selection and IND-enabling study initiation

Quick Facts

Type
Private Biotech
Founded
2018
Lead Stage
Phase I
Website
Visit