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hMG subcutaneous injection
hMG subcutaneous injection is a Growth hormone Small molecule drug developed by Granata Bio Corporation. It is currently in Phase 3 development for Growth hormone deficiency in children.
hMG subcutaneous injection is a recombinant human growth hormone used to treat growth hormone deficiency.
hMG subcutaneous injection is a recombinant human growth hormone used to treat growth hormone deficiency. Used for Growth hormone deficiency in children.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | hMG subcutaneous injection |
|---|---|
| Sponsor | Granata Bio Corporation |
| Drug class | Growth hormone |
| Target | Growth hormone receptor |
| Modality | Small molecule |
| Therapeutic area | Endocrinology |
| Phase | Phase 3 |
Mechanism of action
It works by replacing the body's natural growth hormone to stimulate growth and development in children with growth hormone deficiency. The exact mechanism of action is not fully understood, but it is believed to involve the stimulation of growth plates in bones and the regulation of growth hormone receptors.
Approved indications
- Growth hormone deficiency in children
Common side effects
- Injection site reaction
- Gallstones
- Diabetes mellitus
- Scoliosis
- Headache
- Nausea
- Vomiting
- Abdominal pain
- Fatigue
- Muscle weakness
Key clinical trials
- The Value of Addition of Human Menopausal Gonadotropin Drug Following Oocytes Retrieval in IVF Cycles (PHASE4)
- Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer. (PHASE3)
- Effect of GnRH Agonist Treatment Protocols on Ovarian Reserve (NA)
- Lipid Management in Renal Transplant Recipients Using Evolocumab. (PHASE4)
- Comparative Study on the Efficacy of Ovarian Stimulation Protocols on the Success Rate of ICSI in Female Infertility (PHASE1, PHASE2)
- LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy (PHASE2)
- Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects (PHASE2)
- Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-4 (PHASE3)
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:
- hMG subcutaneous injection CI brief — competitive landscape report
- hMG subcutaneous injection updates RSS · CI watch RSS
- Granata Bio Corporation portfolio CI
Frequently asked questions about hMG subcutaneous injection
What is hMG subcutaneous injection?
How does hMG subcutaneous injection work?
What is hMG subcutaneous injection used for?
Who makes hMG subcutaneous injection?
What drug class is hMG subcutaneous injection in?
What development phase is hMG subcutaneous injection in?
What are the side effects of hMG subcutaneous injection?
What does hMG subcutaneous injection target?
Related
- Drug class: All Growth hormone drugs
- Target: All drugs targeting Growth hormone receptor
- Manufacturer: Granata Bio Corporation — full pipeline
- Therapeutic area: All drugs in Endocrinology
- Indication: Drugs for Growth hormone deficiency in children
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing