Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NNC126-0083 · 4 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| NNC126-0083 | EXPERIMENTAL | - |
| Norditropin NordiFlex® | ACTIVE_COMPARATOR | - |
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| C | EXPERIMENTAL | - |
| D | EXPERIMENTAL | - |
| E | EXPERIMENTAL | - |
| Norditropin® SimpleXx® 0.02 mg/kg + NNC126-0083 | EXPERIMENTAL | - |
| Norditropin® SimpleXx® 0.04 mg/kg + NNC126-0083 | EXPERIMENTAL | - |
| Norditropin® SimpleXx® 0.02 mg/kg + placebo | PLACEBO_COMPARATOR | - |
| Norditropin® SimpleXx® 0.04 mg/kg + placebo | PLACEBO_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| NNC126-0083 | DRUG | One single dose administered in four dose levels in an escalating order |
| somatropin | DRUG | A daily dose of Norditropin NordiFlex® for seven days. Dose will remain constant |
| placebo | DRUG | Dose level 1; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks |
| Norditropin® SimpleXx® | DRUG | One of two dose levels, followed by NNC126-0083, administered subcutaneously (under the skin) |
Inclusion Criteria: * Confirmed diagnosis of growth hormone insufficiency as defined by two different GH provocation tests, defined as a peak of GH level less than 7ng/ml * Pre-pubertal children * Growth hormone replacement treatment for at least three months Exclusion Criteria: * Evidence of tum...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 8 | PHASE3 | Somapacitan |
| Ascendis Pharma A/S | ASND | 3 | PHASE3 | Lonapegsomatropin, Somatropin Pen Injector |
| BioMarin Pharmaceutical Inc. | BMRN | 2 | PHASE2 | Vosoritide, Human Growth Hormone |
| Abbott Laboratories | ABT | 1 | N/A | Undisclosed |
| Pfizer Inc. | PFE | 3 | - | NGENLA |
| Johnson & Johnson | JNJ | 1 | N/A | Undisclosed |
NNC126-0083 is an investigational small molecule being developed for growth hormone disorders, including adult growth hormone deficiency and growth hormone deficiency in children. It is a long-acting growth hormone being studied as a potential treatment option for patients with these conditions.
NNC126-0083 is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting clinical trials to evaluate the safety, pharmacokinetics, and pharmacodynamics of this investigational drug.
NNC126-0083 is in Phase 2 clinical development. It has completed four clinical trials, including two Phase 2 studies and two Phase 1 studies. The drug is still investigational and has not been approved by regulatory authorities for commercial use.
NNC126-0083 has completed four clinical trials: NCT00715689, a Phase 2 dose study in growth hormone deficient adults; NCT00722540, a Phase 1 study in healthy Japanese males; NCT00936403, a Phase 2 single dose trial in growth hormone deficient children; and NCT01034202, a Phase 1 study comparing NNC126-0083 to Norditropin SimpleXx in healthy males.
NNC126-0083 is a long-acting growth hormone designed to replace or supplement endogenous growth hormone in patients with growth hormone deficiency. It is being studied to understand its safety, pharmacokinetics, and pharmacodynamics in both adult and pediatric populations with growth hormone disorders.
NNC126-0083 is not the same as Norditropin. Norditropin is a brand of recombinant human growth hormone also developed by Novo Nordisk. In clinical trial NCT01034202, NNC126-0083 was compared directly to Norditropin SimpleXx to evaluate its safety, pharmacokinetics, and pharmacodynamics in healthy males.