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Mecobalamin

Phase 3

Patients Undergoing Open Thyroid Surgery | Small molecule | Endocrine |JIN MEDICAL INTERNATIONAL LTD.|Last Updated: Dec 10, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment528
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07274696Mecobalamin in Promoting Recurrent Laryngeal Nerve Function Recovery After Thyroid SurgeryPHASE3 NOT YET_RECRUITING 528Dec 1, 2025Dec 1, 2028Dec 10, 20251 China
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Study Endpoints
Primary Endpoints
Jitter
Preoperative, within two weeks after surgery, 1 month postoperative, 3 months postoperative, and 6 months postoperative

Jitter reflects the regularity of the voice in terms of frequency. A smaller jitter value indicates higher regularity of the voice in terms of frequency.

Shimmer
Preoperative, within two weeks after surgery, 1 month postoperative, 3 months postoperative, and 6 months postoperative

Shimmer reflects the regularity of the voice in terms of amplitude. A smaller shimmer value indicates higher regularity of the voice in terms of amplitude.

Fundamental frequency (F0)
Preoperative, within two weeks after surgery, 1 month postoperative, 3 months postoperative, and 6 months postoperative
Maximum Phonational Frequency Range (MPFR)
Preoperative, within two weeks after surgery, 1 month postoperative, 3 months postoperative, and 6 months postoperative

The frequency range from the lowest to the highest pitch a person can produce (in Hz or semitones).

Noise-to-Harmonic Ratio (NHR)
Preoperative, within two weeks after surgery, 1 month postoperative, 3 months postoperative, and 6 months postoperative

The NHR parameter is the ratio of non-harmonic components within the 1,500-4,500 Hz range to harmonic components within the 70-4,500 Hz range. It can be used to assess the proportion of noise components in the voice.

Secondary Endpoints
The Voice Handicap Index-10 (VHI-10)
Preoperative, 1 day postoperative, 1 month postoperative, 3 months postoperative, and 6 months postoperative
The Voice-Related Quality of Life (V-RQOL-10) scale
Preoperative, 1 day postoperative, 1 month postoperative, 3 months postoperative, and 6 months postoperative
The subjective auditory-perceptual assessment of voice quality (GRBAS Scale)
Preoperative, 1 day postoperative, 1 month postoperative, 3 months postoperative, and 6 months postoperative
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Mecobalamin GroupEXPERIMENTALThe patient began taking mecobalamin tablets orally within 24 hours after thyroid surgery, three times a day, 0.5mg each time, for three consecutive months.
Control groupPLACEBO_COMPARATORThe patient was given a placebo within 24 hours after thyroid surgery, which was identical in appearance, size, color, dosage form, weight, taste, and smell to mecobalamin tablets, three times a day, 0.5mg each time, for three consecutive months.
Interventions
NameTypeDescription
MecobalaminDRUGThe patient began taking mecobalamin tablets orally within 24 hours after thyroid surgery, three times a day, 0.5mg each time, for three consecutive months.
placeboDRUGThe patient was given a placebo within 24 hours after thyroid surgery, which was identical in appearance, size, color, dosage form, weight, taste, and smell to mecobalamin tablets, three times a day, 0.5mg each time, for three consecutive months.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Patients aged 18-75 years (inclusive) Scheduled to undergo thyroid surgery (including thyroid gland and isthmus resection, total thyroidectomy, etc.) Preoperative laryngoscopy confirms normal bilateral vocal cord mobility Intraoperative neuromonitoring (IONM) technology is used ...

Countries:China
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07274696studyFirstPostDate: changed