Monepantel: a brain-penetrant mTOR inhibitor

FDA Lifts Clinical Hold on NUZ-001

  • U.S. FDA lifts the Clinical Hold on NUZ‑001, Neurizon®’s lead investigational therapy for ALS
  • Clears the way for entry into the HEALEY ALS Platform Trial expected to commence in Q4 CY2025
  • IND supported by robust preclinical safety data and comprehensive manufacturing and quality information from the previously signed Elanco licensing agreement
  • Expedites NUZ-001 as a platform molecule with pipeline expansion potential for other neurodegenerative diseases
  • Positions Neurizon for accelerated regulatory pathways and future partnering opportunities
2 Likes

FDA Clears NUZ-001 for Entry into HEALEY ALS Platform Trial

Highlights:

  • FDA has completed their review of the Neurizon NUZ-001 regimen to the HEALEY ALS Platform Trial Master Protocol
  • This marks the official entry of NUZ-001 as Regimen I in the HEALEY ALS Platform Trial
  • Next steps include obtaining single IRB approval, site initiations and clinical start-up activities ahead of commencement of patient enrollment expected early in 2026
  • Milestone strengthens Neurizon’s pathway toward advancing a potential new treatment for ALS
2 Likes

NUZ-001 Data Shows Multi-Pathway Protein Clearance

New preclinical data show NUZ-001 increases activity of multiple protein clearance pathways in neuronal models
Demonstrates enhanced activity of both autophagy and proteasomal systems, key processes involved in clearing aggregated proteins
Supports a differentiated, multi-pathway approach targeting disrupted protein homeostasis in
neurodegenerative disease
Findings further characterise the biological activity of NUZ-001 and strengthen its scientific foundation
Continues to build evidence supporting NUZ-001 as it progresses through clinical evaluation

If anyone here knows how to purchase and deliver monepantel… Asking for a friend :eyes:

Procurement Market Analysis: Standardized Monepantel (Zolvix)

In the context of biotech and healthcare longevity research, identifying and sourcing compounds that influence metabolic pathways requires navigating fragmented international supply chains. Procuring standardized Monepantel presents an immediate logistical hurdle: the compound is not commercially manufactured in tablet or capsule form.

Acquiring Monepantel at scale practically dictates sourcing veterinary oral drenches (Zolvix and Zolvix Plus) from agricultural suppliers in Australia, New Zealand, and the UK. Currently, Monepantel lacks FDA approval for domestic veterinary use in the US, making direct local procurement impossible outside of highly priced research chemical suppliers.

A critical analytical constraint: The widely available “Zolvix Plus” formulations contain Abamectin (2 mg/mL) alongside Monepantel (25 mg/mL). If your objective is isolated molecular investigation, the presence of a macrocyclic lactone like Abamectin introduces significant confounding variables and an altered toxicity profile. Pure research-grade Monepantel powder is included at Rank 10 to illustrate the extreme cost disparity of isolating the compound without parasiticides.

All veterinary liquid formulations below contain a standardized concentration of 25 mg/mL of Monepantel. Foreign currencies (AUD, GBP, NZD) have been converted to approximate USD values for direct comparison.

Rank Product/Brand Name (Exact title) Vendor Total Weight (Original Unit & Grams) Total Price (USD) Cost Per 250mg of Monepantel 3 (Zolvix) Number Capsules or tablets Needed
1 Zolvix Plus Low Voloume Oral Anthelmintic Broad Spectrum Drench for Sheep 10 Lt The Farmers Mailbox (via eBay) 10 Liters (approx. 10,000g) $1,938.45 **$1.94**
(Calculation: 1938.45 / 250000 * 250)
0 (Commercial capsules do not exist. Requires 10 mL liquid dose.)
2 Elanco Zolvix PLUS - Combination Sheep Drench (10L) Aussie Vet Products 10 Liters (approx. 10,000g) $2,035.12 **$2.04**
(Calculation: 2035.12 / 250000 * 250)
0 (Commercial capsules do not exist. Requires 10 mL liquid dose.)
3 Zolvix Sheep Drench Oral Solution - POM (1L) StowAg 1 Liter (approx. 1,000g) $204.12 **$2.04**
(Calculation: 204.12 / 25000 * 250)
0 (Commercial capsules do not exist. Requires 10 mL liquid dose.)
4 Elanco Zolvix PLUS - Combination Sheep Drench (5L) Aussie Vet Products 5 Liters (approx. 5,000g) $1,086.77 **$2.17**
(Calculation: 1086.77 / 125000 * 250)
0 (Commercial capsules do not exist. Requires 10 mL liquid dose.)
5 Zolvix Plus for Sheep and Cattle (1L) Specialist Sales 1 Liter (approx. 1,000g) $230.75 **$2.31**
(Calculation: 230.75 / 25000 * 250)
0 (Commercial capsules do not exist. Requires 10 mL liquid dose.)
6 Zolvix Plus Sheep & Cattle Oral Drench 1L The Farmers Mailbox 1 Liter (approx. 1,000g) $232.58 **$2.33**
(Calculation: 232.58 / 25000 * 250)
0 (Commercial capsules do not exist. Requires 10 mL liquid dose.)
7 Zolvix Plus Broad Spectrum Oral (1L) N & W Livestock 1 Liter (approx. 1,000g) $234.00 **$2.34**
(Calculation: 234.00 / 25000 * 250)
0 (Commercial capsules do not exist. Requires 10 mL liquid dose.)
8 Elanco Zolvix PLUS - Combination Sheep Drench (1L) Aussie Vet Products 1 Liter (approx. 1,000g) $259.97 **$2.60**
(Calculation: 259.97 / 25000 * 250)
0 (Commercial capsules do not exist. Requires 10 mL liquid dose.)
9 Zolvix Plus Oral Drench for Sheep and Cattle (1L) PGG Wrightson 1 Liter (approx. 1,000g) $311.40 **$3.11**
(Calculation: 311.40 / 25000 * 250)
0 (Commercial capsules do not exist. Requires 10 mL liquid dose.)
10 Monepantel TargetMol 100 mg (0.1g) $1,530.00 **$3,825.00**
(Calculation: 1530.00 / 100 * 250)
0 (Raw powder. Requires exact weight measurement; no commercial capsule exists.)

Shipping & Procurement Logistics

  • Customs & Importation: Because Zolvix is an unapproved veterinary drug in the USA, importing it from foreign agricultural suppliers carries an inherent risk of seizure by US Customs and Border Protection (CBP) or the FDA.
  • Freight Surcharges: International shipping is not included in the base prices above and must be scheduled via third-party freight forwarders or international courier programs (e.g., DHL).
    • Australia/NZ to USA: Expect flat-rate international freight fees ranging from $50.00 to $120.00 USD, heavily dependent on the total liquid weight. Heavy drums (like the 10L option) incur substantial dimensional weight surcharges.
    • UK to USA: Requires specific agricultural export clearance for POM-VPS (Prescription Only Medicines - Veterinarian, Pharmacist, Suitably Qualified Person) tier medications.
    • eBay Global Shipping: Rank 1 leverages eBay’s global network, offering the highest probability of streamlined customs clearance, with shipping rates calculated dynamically at checkout based on zip code.
    • TargetMol: Source 10 ships domestically from USA stock. Shipping is standard hazardous chemical freight, typically $35.00 to $50.00 depending on cold-chain requirements.

Thanks. That’s a problem. Abamectin is an anthelmintic like ivermectin. We need pure Monepantel (Zolvix). Courtesy of ChatGPT:

It’s also approved in Australia and NZ, but it seems only Zolvix Plus is approved there.

ChatGPT: “HPRA says that from 1 December 2025, all antiparasitic veterinary medicinal products for use in food-producing animals in Ireland are subject to veterinary prescription (POM).”

So if someone has a farm and is willing to reexport…