Medicine
Niktimvo 22 mg/0.44 mL injection
Niktimvo 22 mg/0.44 mL injection is a prescription medicine containing Axatilimab for intravenous use, marketed by Incyte, 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 refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to…
Key facts
- Active ingredient (INN)
- Axatilimab
- Brand
- Niktimvo
- Strength
- 22 mg/0.44 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 0.44 mL
- Marketing authorisation holder
- Incyte
- Manufacturer
- Incyte
- Origin register
- US FDA, United States
- Storage
- Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze or shake.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 January 2025
- Identifiers
- RxCUI 2703023, 2703024, 2703025 +5DailyMed set ID bb6dba23-e7a6-4765-a1e6-b9e277ce0381NDC 50881-023Application BLA761411
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, single-use in 1 carton / .44 mL in 1 vial, single-use | 50881-023-11 | Incyte | 15 January 2025 |
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 14 August 2024 | 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
Other strengths and forms of Axatilimab
Clinical summary
Axatilimab is a colony stimulating factor-1 receptor blocker indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult, among other approved uses. MedsAcross supplies Axatilimab 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 AxatilimabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- NIKTIMVO prescribing information (Incyte) · U.S. National Library of Medicine, DailyMed
Need Niktimvo 22 mg/0.44 mL 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.