Medicine
Zycubo 2.9 mg powder for injection
Zycubo 2.9 mg powder for injection is a prescription medicine containing Copper histidinate for subcutaneous use, marketed by Sentynl Therapeutics, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store ZYCUBO vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original…
Key facts
- Active ingredient (INN)
- Copper histidinate
- Brand
- Zycubo
- Strength
- 2.9 mg
- Dosage form
- Powder for injection
- Route
- Subcutaneous
- Packs
- 1 vial
- Marketing authorisation holder
- Sentynl Therapeutics
- Manufacturer
- Sentynl Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store ZYCUBO vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton. Store ZYCUBO reconstituted solution either refrigerated or at controlled room temperature.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 12 January 2026
- Identifiers
- RxCUI 2732219, 2732224DailyMed set ID e3aeefc2-f44d-4337-9c2e-3dba44a89e48NDC 42358-329Application NDA211241
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial, glass in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, glass | 42358-329-01 | Sentynl Therapeutics | 26 January 2026 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 12 January 2026 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Clinical summary
Copper histidinate is a prescription medicine indicated for the treatment of Menkes disease in pediatric patients, among other approved uses. It is available as powder for injection for subcutaneous use. MedsAcross supplies Copper histidinate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Copper histidinateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Zycubo prescribing information (Sentynl Therapeutics) · U.S. National Library of Medicine, DailyMed
Need Zycubo 2.9 mg powder for injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.