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Breastmilk
Breastmilk is a Biologic drug developed by Al Adan Hospital Kuwait. It is currently in Phase 1 development. Also known as: experimental.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Breastmilk |
|---|---|
| Also known as | experimental |
| Sponsor | Al Adan Hospital Kuwait |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Pumping to Up Maternal Milk Production for Preterms (NA)
- Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia (NA)
- Breastmilk and the Link to Overweight/Obesity and Maternal Diet in the Mother-breastmilk-child Triad
- Study of Analgesics Drug and Human Milk Transfer in Mature Milk, to Avoid Breastfeeding Cessation Without Scientific Probes
- Human Breast Milk's Role in Food Allergy Development
- Learning Early Infant Feeding Cues (NA)
- Vitamin D Sulfates in Breastmilk (NA)
- Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Breastmilk CI brief — competitive landscape report
- Breastmilk updates RSS · CI watch RSS
- Al Adan Hospital Kuwait portfolio CI
Frequently asked questions about Breastmilk
What is Breastmilk?
Who makes Breastmilk?
Is Breastmilk also known as anything else?
What development phase is Breastmilk in?
Related
- Manufacturer: Al Adan Hospital Kuwait — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: experimental
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing