Mirivadelgat

CAS 1804941-96-5

MF C30H34FN3O5 MW535.6 g/mol

L-Valine, [2-[4-(cyclopropylmethoxy)-3-[[[(3-fluoro-4-methoxyphenyl)methyl]amino]carbonyl]phenyl]-3-pyridinyl]methyl ester

[2-[4-(cyclopropylmethoxy)-3-[(3-fluoro-4-methoxyphenyl)methylcarbamoyl]phenyl]-3-pyridinyl]methyl (2S)-2-amino-3-methylbutanoate

L-Valine, [2-[4-(cyclopropylmethoxy)-3-[[[(3-fluoro-4-methoxyphenyl)methyl]amino]carbonyl]phenyl]-3-pyridinyl]methyl ester

{2-[4-(cyclopropylmethoxy)-3-{[(3-fluoro-4-methoxyphenyl)methyl]carbamoyl}phenyl]pyridin-3-yl}methyl
L-valinate
aldehyde dehydrogenase 2 activator, antianaemic, FP 045, 22TB7Q431D

Mirivadelgat (also known as FP-045) is a first-in-class, orally bioavailable small molecule that acts as a selective activator of mitochondrial aldehyde dehydrogenase 2 (ALDH2). Developed by Foresee Pharmaceuticals, this novel therapy helps cells clear toxic reactive aldehydes, reducing mitochondrial stress, cellular inflammation, and fibrosis. It is currently being evaluated in clinical trials for its disease-modifying potential across several serious conditions.

Current Clinical Development

The drug is undergoing clinical evaluation for multiple indications:

• Pulmonary Hypertension with Interstitial Lung Disease (PH-ILD): Mirivadelgat is currently in a multinational, Phase 2 trial known as the WINDWARD Study. The double-blind trial is assessing whether the drug can safely improve pulmonary vascular resistance and overall lung and cardiac function.
• Parkinson’s Disease: The drug was selected for the SLEIPNIR multi-drug Phase 2a platform trial funded by Cure Parkinson’s. It will evaluate mirivadelgat’s safety, brain penetration, and ability to clear the toxic waste products that drive Parkinson’s progression.
• Fanconi’s Anaemia: It has also reached Phase I/II testing for this rare genetic condition.
• Other Conditions: Early-stage Phase I research has explored its utility for metabolic and kidney disorders.

Mechanism of Action

When administered once daily, mirivadelgat targets deep cellular mechanics:

1. ALDH2 Activation: It binds selectively to the ALDH2 enzyme in the mitochondria.
2. Waste Clearance: It accelerates the metabolism of toxic reactive aldehydes produced by oxidative stress.
3. Mitochondrial Protection: Lowering toxic aldehyde levels protects cellular structures and shields tissues from fibrosis and dysfunction.

Mirivadelgat is an orally bioavailable selective activator of the mitochondrial isoform of aldehyde dehydrogenase (ALDH2), with potential protective activity. Upon oral administration, mirivadelgat increases ALDH2 activity. This increases the metabolism of toxic reactive aldehydes and lowers the level of the toxic aldehydes. This may protect cells from the toxic aldehydes and prevent mitochondria diseases and disorders. ALDH2, a mitochondrial regulator of toxic aldehyde metabolism, plays an important role in the metabolism of toxic aldehydes. Toxic aldehydes are produced by oxidative stress.

Study to Evaluate Safety and Efficacy of Mirivadelgat in PH-ILD

CTID: NCT06475781, Phase: Phase 2, Status: Recruiting, Date: 2025-10-06

• OriginatorForesee Pharmaceuticals
• ClassAntianaemics; Antihypertensives; Cardiovascular therapies; Hepatoprotectants; Small molecules
• Mechanism of ActionAldehyde dehydrogenase 2 stimulants
• Phase IIPulmonary hypertension
• Phase I/IIFanconi’s anaemia
• Phase IKidney disorders; Metabolic disorders
• No development reportedCardiovascular disorders; Non-alcoholic fatty liver disease; Non-alcoholic steatohepatitis
• 08 Jun 2026Foresee Pharmaceuticals in collaboration with Haukeland University Hospital plans a phase IIa SLEIPNIR Platform trial for Parkinson’s disease (PO)
• 02 Jun 2026Helse Bergen HF, Cure Parkinson’s, Norwegian Parkinson’s Association plan the phase IIa SLEIPNIR-2 trial for Parkinson’s disease in Norway (PO, Capsule), in September 2026 , (CTIS2025-523570-17-00)
• 28 Oct 2025No recent reports of development identified for phase-I development in Cardiovascular-disorders in USA (PO)

PAT

https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2015127137&_cid=P20-MR2WCE-70172-1

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References

• Mitochondrial aldehyde dehydrogenase-2 binding compounds and methods of use thereofPublication Number: US-9879036-B2Priority Date: 2014-02-19Grant Date: 2018-01-30
• Mitochondrial aldehyde dehydrogenase-2 binding compounds and methods of use thereofPublication Number: US-2017057982-A1Priority Date: 2014-02-19
• Mitochondrial aldehyde dehydrogenase 2 (aldh2) binding polycyclic amides and their use for the treatment of cancerPublication Number: EP-3107899-B1Priority Date: 2014-02-19Grant Date: 2020-08-12

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