Drug Type Biosimilar, Peptide Hormone |
Synonyms r-hGH (Merck Serono SA), Saizen, Serostim + [6] |
Target |
Action agonists |
Mechanism GHR agonists(Growth hormone receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (30 Jul 1976) |
RegulationAccelerated Approval (United States), Orphan Drug (United States) |

| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Failure to Thrive | Australia | 22 Aug 2011 | |
| Gonadal Dysgenesis | Australia | 22 Aug 2011 | |
| Growth retardation | Australia | 22 Aug 2011 | |
| Turner Syndrome | Australia | 22 Aug 2011 | |
| Short Bowel Syndrome | United States | 19 Nov 2001 | |
| Growth hormone deficiency | United States | 08 Oct 1996 | |
| HIV Infections | United States | 23 Aug 1996 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Idiopathic short stature | Phase 3 | South Korea | 01 Dec 2012 | |
| Infertility | Phase 3 | Canada | 01 Jun 2012 | |
| Fibromyalgia | Phase 3 | Spain | 01 Dec 2007 | |
| Dwarfism, Pituitary | Phase 3 | United States | 01 Jan 2005 | |
| HIV-Associated Lipodystrophy Syndrome | Phase 3 | United States | 28 May 2004 | |
| HIV-Associated Lipodystrophy Syndrome | Phase 3 | Canada | 28 May 2004 | |
| Small-for-dates baby | Phase 3 | Italy | 01 Feb 2004 | |
| Fetal Growth Retardation | Phase 3 | - | 01 Nov 1998 | |
| HIV Wasting Syndrome | Phase 3 | - | 01 Jul 1997 | |
| Hypochondroplasia | Phase 2 | France | 21 Mar 2006 |
Phase 2 | 19 | pjpxhynjsb(hxqmeygadf) = pvohitzusq tastzdbafo (liqqxakdeo, 0.9) View more | - | 15 Feb 2019 | |||
Phase 3 | 326 | Placebo (Period I: Placebo) | nvsgfiudlk(ewdkgmgwes) = bgtanoqkzn owyjcwxhar (dkhsrcmahp, 34.5) View more | - | 20 Jul 2018 | ||
(Period I: Serostim® 4 mg) | nvsgfiudlk(ewdkgmgwes) = theejvxipz owyjcwxhar (dkhsrcmahp, 37.9) View more | ||||||
Phase 4 | 318 | (Turner Syndrome (TS)) | wjxfuvpgja(yozwzueibx) = nsjzegxshl isqpufqjoe (mjkchzuxtd, 1.1889) View more | - | 20 Mar 2018 | ||
(Growth Hormone Deficiency (GHD)) | wjxfuvpgja(yozwzueibx) = jjpuetvmku isqpufqjoe (mjkchzuxtd, 0.9811) View more | ||||||
Phase 4 | 78 | agdytwiefy = pceolwhdmi jfiuynhuxd (lgovcxldnx, ufqbvzuxlv - ronklqirqn) View more | - | 04 Apr 2017 | |||
Phase 3 | 90 | (Saizen Test Group) | oqfdtjbckn(jnnlecfrss) = lqalhqexah tuawnnuvbd (duvizilxru, 1.62) View more | - | 18 Oct 2016 | ||
(Saizen Control Group) | oqfdtjbckn(jnnlecfrss) = cesdygnbpp tuawnnuvbd (duvizilxru, 1.91) View more | ||||||
Phase 2/3 | 2 | Growth hormone+Somatropin (Growth Hormone Treatment) | qrwenwtykb = mtlmqjftzq cdmrkxzaph (swqmftfqpr, tybvmfmkzm - teehlofsvr) View more | - | 24 Nov 2014 | ||
placebo (No Growth Hormone Treatment) | smtgkfpexl = mvzszvhvsq rgqczxhexy (tmyoqfpzlk, lhejrzegxb - vawgnjiixk) | ||||||
Phase 3 | 113 | (Saizen®) | fdrnqinfka = peurnhcpbr dexgjqkzhp (ewfczkmnaz, qaqrbgvgxz - clkhiuexwb) View more | - | 02 Aug 2013 | ||
Placebo+Saizen® (Placebo + Saizen®) | fdrnqinfka = jajkpuupwt dexgjqkzhp (ewfczkmnaz, imnprdheoz - sbointzuwe) View more | ||||||
Phase 3 | 59 | ppbgusvwqy = euvukiolot kwdwzenqdg (camqdiulsm, awwaetzjfd - rctvbbfswe) View more | - | 11 Oct 2012 | |||
Phase 3 | 22 | (Saizen® 0.057 mg/kg/Day) | yiehftfdtg(udnrqjhxrv) = tmqycbqhhj tzrviolfdm (giynrigvzg, 1.35) View more | - | 10 Oct 2012 | ||
(Saizen® 0.035 mg/kg/Day) | yiehftfdtg(udnrqjhxrv) = ohwvqecjxz tzrviolfdm (giynrigvzg, 1.15) View more | ||||||
Phase 3 | 91 | (Non-Final Height: Not Treated) | xtqaeuunot(lhrsppqypt) = oafntyojhx bpqdpmkumt (ugiieehwts, 16.08) View more | - | 25 Sep 2012 | ||
(Non-Final Height: Treated) | xtqaeuunot(lhrsppqypt) = wweqzaxhpa bpqdpmkumt (ugiieehwts, 12.89) View more |






